563 Arch Loader v4.0 10272008_Final

M5.

Medidata Rave® 5.6.3 Architect Loader Training Manual Version 4.0

Medidata Solutions Worldwide Corporate Office 79 Fifth Avenue New York, NY 10003 +1 212 918 1800

Medidata Solutions, Inc. Proprietary – Medidata and Authorized Clients Only. This document contains proprietary information that shall be distributed, routed or made available only within Medidata and its authorized clients, except with written permission of Medidata. February 2008.

Medidata Rave 5.6

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Architect Loader Training Manual

PROPRIETARY – LIMITED DISTRIBUTION

Document Version 4.0

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Revision History Version

Date

Changed by

1.0

January 2007

2.0

November 2007

3.0

May 2008

Dana Cooperman, Instructional Designer Carrie Barent, Instructional Designer Carrie Barent, Instructional Designer

Description of Changes Original Release

5.6.2 Updates: Synchronizing Object Identifiers 5.6.3 Updates: •

Downloading a Draft or Version

•

CRF Draft Worksheet

•

Checks Worksheet

•

Check Actions Worksheet

•

Derivations Worksheet

•

Custom Function Worksheet

•

4.0

October 27, 2008

Shari Berman Instructional Designer

Appendix C: Specifying to Sync with a Version

Minor text edits to page 32 through 36 (results for leaving items blank in workbook used for upload) •

DraftFormActive

•

DraftFieldActive

•

IsVisible

Medidata Solutions, Inc. Proprietary - Medidata and Authorized Clients Only. See proprietary restrictions on title page. Information in this document is subject to change without notice. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including, but not limited to, photocopying and recording, for any purpose without the express permission of Medidata Solutions, Inc. © Copyright 2008 Medidata Solutions, Inc. All rights reserved. Medidata Solutions Worldwide, Medidata Rave, Medidata Edge, Medidata Services, Medidata University and their respective logos are trademarks or registered trademarks of Medidata Solutions, Inc. All other brands or product names used in this document are trademarks or registered trademarks of their respective owners.



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Disclaimer: Given that Rave allows users to translate and change text strings, the screens shown in this document are only a representation of the product and may not match the actual Rave interface you are currently using.

Medidata Rave® 5.6.2 is certified by the Clinical Data Interchange Standards Consortium (CDISC) for Operational Data Modeling (ODM) standards ODM v1.2 and ODM v1.2.1.

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Table of Contents Welcome .................................................................................. 8 Using This Manual .........................................................................................8

Introduction to the Architect Loader Utility ............................ 10 Downloading a Draft or Version ............................................. 12 Architect Loader Overview ..........................................................................14 Downloading a Draft or Version ..................................................................15

The Architect Draft Spreadsheet ............................................ 18 Architect Draft Spreadsheet Overview ........................................................20 CRF Draft Objects in the Spreadsheet .........................................................21 Common Controls in the Spreadsheet .........................................................22 CRF Draft Objects vs. External Objects in the Spreadsheet .........................25 Worksheet Details in the Spreadsheet ........................................................26 CRF Draft Worksheet .................................................................................26 Forms Worksheet ......................................................................................31 Fields Worksheet.......................................................................................33 Folders Worksheet.....................................................................................38 Data Dictionaries Worksheet....................................................................... 39 Data Dictionary Entries Worksheet...............................................................39 Unit Dictionaries Worksheet........................................................................40 Unit Dictionary Entries Worksheet: ..............................................................40 Matrices Worksheet ...................................................................................42 MatrixN#OID Worksheet ............................................................................43 Checks Worksheet.....................................................................................44 Check Steps Worksheet .............................................................................45 Check Actions Worksheet ...........................................................................47 Derivations Worksheet...............................................................................53 Derivation Steps Worksheet: ......................................................................55 Lab Variable Mappings ...............................................................................58 Custom Functions Worksheet...................................................................... 59 Example: Adding a New Form, Field, and Dictionary ...................................60 Editing or Deleting Data (Protected Worksheets)........................................62

Uploading a Draft ................................................................... 64 The Upload Process .....................................................................................66 Uploading a Draft Spreadsheet....................................................................68 Understanding the Upload Progress Page ...................................................71 Warnings in the Upload Process ..................................................................74 Errors in the Upload Process .......................................................................75

Partial Uploads ....................................................................... 78 Partial Uploads............................................................................................80

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After a Successful Upload… .................................................... 82 What Happens after a Draft Spreadsheet is Uploaded? ...............................84 The Upload Trail ..........................................................................................85

Downloading a Draft Spreadsheet Template........................... 88 Downloading a Draft Spreadsheet Template ...............................................90

Appendix A: Architect Security Permiss ions ........................... 94 Architect Security Project Permissions ..........................................................94 Architect Security Global Library Permissions ................................................94

Appendix B: Usage Recommendations.................................... 96 When Do I use Architect Loader?.................................................................96 What Should I Use it For?...........................................................................96 When Might Editing in Rave be more Efficient? ..............................................96

Appendix C: Synchronizing Object Identifiers (OIDs)............. 98 Why Would You Synchronize OIDs? ............................................................99 Understanding System-Defined OIDs ........................................................100 Specifying to Sync with a Version .............................................................101 Synchronizing OIDs: An Example ..............................................................102



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Welcome This manual is designed to be a useful and detailed reference for the Architect Loader utility in Medidata Rave.

Using This Manual The layout and format of this manual is intended to be as user-friendly as possible. The following legend should help differentiate aspects of the information contained in the Training Manual:

These bullets show a list of definitions: •

•

These bullets show a list of options:  

These Numbered Lists Show General Step-by-step Procedures: 1. 2. These bullets show a list of options for a step. 



Note: Information in these gray boxes is to be noted or critical. Be sure to pay

special attention to the instructions or information here. In this manual, there are many screenshots of the windows, dialog boxes, icons and hyperlinks. When instructed to click a specific link or button, a picture will be included in the left margin. For example: Click on the Home Tab or the Home icon, in the upper right corner of the screen, to return to the home page.

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Introduction to the Architect Loader Utility The Architect Loader utility in Rave enables a user to take all the definitions of a project draft or Global Library Volume in Architect and extract them into an Excel spreadsheet, where offline documentation and maintenance of the definitions can be conducted. The downloaded and maintained Excel file can be uploaded back into the Rave system into its srcinal project or Global Library Volume, or can be used to create a new project or Global Library Volume. Once uploaded, the draft can be maintained in the Architect module.

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Downloading a Draft or Version This chapter will cover the following topics:

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

Architect Loader Overview



Downloading a Draft or Version



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Architect Loader Overview The Architect Loader utility in Rave enables a user to take all the definitions of a project draft or Global Library Volume in Architect and extract them into an Excel spreadsheet, where offline documentation and maintenance of the definitions can be conducted. The downloaded and maintained Excel file can be uploaded back into the Rave system into its srcinal project or Global Library Volume, or can be used to create a new project or Global Library Volume. Once uploaded, the draft can be maintained in the Architect module. Using the Architect Loader a Rave user can: 

Create new CRF drafts based on drafts of Projects and Global Library Volumes from local and remote Rave databases



Download CRF draft and Global Library Volume data for offline editing in an Excel spreadsheet.



Copy large chunks of data from one draft to another



Upload spreadsheets into a different project or Global Library Volume within the same database, or into another database



Update and save the existing draft



Download a draft spreadsheet template

The CRF draft data that is downloaded is stored in an XML spreadsheet format that is compatible with MS Excel 2002+. Access to the Architect Loader is available to users with the following Architect Security permissions: 

Global Library: Upload Draft and/or Download Draft



Architect Project: Upload Draft and/or Download Draft

Refer to Appendix A of this manual for additional information. Typically, the following process will be used when taking advantage of the Architect Loader utility:

Step #

Description

1

Build a project or Global Library Volume in Architect

2

Download the project or Global Library Volume draft or version contents into an Architect Loader spreadsheet

3

Edit the downloaded contents in the Architect Loader spreadsheet

4

Update the CRF Draft Worksheet to specify the target location to which the spreadsheet will be uploaded

5

Upload the spreadsheet to the target location

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Downloading a Draft or Version The Architect Loader can be used to download object definitions for a CRF or Global Library Volume draft or version. You can download a complete draft or version, or you can choose to download definitions related to specific objects. During the download, data is extracted into an Excel spreadsheet for offline documentation and maintenance.

Note: The CRF Draft worksheet will always be included in the downloaded

spreadsheet, whether a full or partial download is conducted.

To Download a Draft or Version using the Architect Loader: 1. Access the Architect Module by clicking the Architect link in the sidebar of the Rave homepage.

2. Access a project or Global Library Volume by clicking on the Project or Global Library Volume name in its respective list.

3. Access the draft or version main page by clicking on the desired draft or version name in its respective list.



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4. In the Draft or Version Summary/Download window of the Draft or Version main page, a list of object types is displayed. To include an object type in your download, check the Include in Download checkbox for that object. All boxes are checked by default. Uncheck the box next to any objects that should not be downloaded. 5. Uncheck the Protect Worksheets checkbox if you want the downloaded worksheets to be un-protected. Refer to the “Editing or Deleting Data (Protected Worksheets)” section of this manual for more information. 6. Click the Download link to download the draft or version spreadsheet. The Download link is only available to users with the Architect Security permission to Download.

7. A pop-up is displayed, indicating that a compressed (zip) file must be downloaded to access the spreadsheet. Click Save, and select the location to which the compressed file should be downloaded.

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8.


Browse to the desired location and click Save to save the compressed file. The filename defaults to: <”Project_or_GLV_Name”_”Draft_or_Version_Name”.zip>.

9. Once the download is complete, use your local computer tools to navigate to the saved file. Double-click the file to launch the compressed file. Double-click the spreadsheet filename to launch the spreadsheet in the Microsoft Excel application.

10. When the spreadsheet is launched, it is displayed in the user’s default locale. The contents can be edited as needed. Refer to the next sections of the manual for additional information.



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The Architect Draft Spreadsheet This section will cover the following topics:

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

Architect Draft Spreadsheet Object Overview



CRF Draft Objects in the Spreadsheet



Common Controls in the Spreadsheet

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CRF Draft Objects vs. External Objects in the Spreadsheet

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Worksheet Details in the Spreadsheet

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Example: Adding a New Form, Field, and Dictionary



Editing or Deleting Data (Protected Worksheets)



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Architect Draft Spreadsheet Overview Within the spreadsheet, each object-type sits on its own worksheet. For each object that resides on the spreadsheet, each property is listed. For example, a form object will display the form name, OID, whether it’s template or log, the ordinal, the signature confirmation setting, et cetera. Each property that is defined in Architect is represented on the spreadsheet. Users can move the various worksheets and edit the object definitions as needed, add new definitions, or delete existing definitions. Once all edits have been made, the user will update the Draft worksheet – the first worksheet in thethe spreadsheet. Draft worksheet is used to the iftarget draft into which spreadsheetThe contents will be uploaded. Forspecify example, the spreadsheet will be used to create a new project in another Rave URL, the Draft worksheet would be updated to reflect the name of the project and draft that will be created during the upload process.

Note: The information specified in the Draft worksheet dictates where the

contents of the spreadsheet end up. This worksheet must be filled out carefully. At this point, we have downloaded the project draft or version. Next we’ll take a look at the contents of each worksheet and how they can be edited.

Step #

Description

1


2


3


4


5


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CRF Draft Objects in the Spreadsheet Within the Architect Loader spreadsheet, objects are represented in text format on object-specific worksheets. For example, a Fields worksheet lists each field in the downloaded draft or version, along with its properties as defined in the Architect module. Each property is stored in its own cell of the spreadsheet. To edit a property, simply click in the cell and start typing, or select from a list of pre-defined values available in a dropdown list within the cell. The draft object-types listed below each are represented on their own worksheets within the Architect Loader spreadsheet. In many cases, data from one worksheet is available for selection on another. For example, the Fields worksheet depends on Form OIDs entered on the forms worksheet, when specified what form a field will reside on. Based on these dependencies, below is the recommended order in which the worksheets should be filled out. 1. Custom Functions 2. Folders 3. Forms 4. Matrices 5. Data Dictionaries 6. Data Dictionary Entries 7. Unit Dictionaries 8. Unit Dictionary Entries 9. Fields 10. Checks 11. Check Steps 12. Derivations 13. Derivation Steps 14. Lab Variable Mappings 15. CRF Draft

Note: Each object listed above is found on its own worksheet in the Architect Draft

Spreadsheet. For brief definitions of each object refer to the tables on the following pages. For detailed information on how each object is built and maintained, refer to the Rave Architect Training Manual.



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Common Controls in the Spreadsheet The Architect Loader spreadsheet has certain functionality that is common across all worksheets – navigation, sorting, color-coding, text selection, and more. Each of these common controls is described below.

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Each object-type resides on its own worksheet within the same spreadsheet. To access the worksheet for a particular object-type, click the object-type tab at the bottom of the page. Each tab is clearly marked with the name of the object-type it represents.



Each available property for an object type is displayed in a column on the worksheet, as seen below. The exception to this rule is the individual matrix worksheets. In these worksheets, rows represent forms and columns represent folders.



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In parent-child relationships, as seen across data dictionaries and their entries, unit dictionaries and their entries, forms and their fields, etc, the child object references the parent object Name or OID on the child worksheet. For example, the Data Dictionary “Race” will be an entry on the Data Dictionary worksheet (parent).

On the Data Dictionary Entries worksheet (child), the data dictionary entries will be listed, all referencing the “Race” Dictionary Name.



The child records for each parent Name/OID are grouped and alternately shaded on the worksheet for child objects, as seen in the screenshot above. This is for clarity only, to differentiate between the children of different parents.



Each column heading on a worksheet has a filter that enables a user to filter the list by selecting the desired value in the drop down list. To access the filter, click the dropdown list in the column header.



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Object properties that require users to choose from a list of predefined values (as available in Rave Architect) are available as drop down lists on the worksheet cell. For example, Edit Check Actions are selected from a list of pre-defined actions. This prevents the user from entering an invalid value.



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When entering values into the spreadsheet, all rules that apply in Architect should be adhered to. For example, when defining a form in the spreadsheet, the OID must be unique among the other form OIDs. The OID must be between 1 and 50 alphanumeric characters, and may only include the special character underscore (_). The spreadsheet will allow you to enter values that do not adhere to that standard; however when the file is uploaded into the target database, the invalid value will be returned as an error and the spreadsheet (in its entirety) will not be uploaded.



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CRF Draft Objects vs. External Objects in the Spreadsheet There are two types of draft objects in the XML spreadsheet created by the Architect Loader: Draft Objects and External Objects. Draft Objects are entirely defined within the spreadsheet – they are specific to a CRF draft (as opposed to being a global setting on a URL). The CRF Draft Objects within the spreadsheet are those that we listed earlier in the manual, in the CRF Draft Objects section. Each draft object has its own worksheet in the spreadsheet; they are the various items that you define when building a CRF Draft within the Architect Module. Each of these items is defined completely within the Architect module. They may contain references to items defined on a URL-wide (configuration) basis (for example, a role – specified in the global core configuration – may be referenced in an edit check action or to review/verify a field), but the base elements of each object are defined completely within Architect. That behavior is mimicked within the XML spreadsheet. External Objects are objects that are mentioned in the spreadsheet but that are defined outside the CRF Draft. These objects consist of localizable strings (project names, role names, query messages, etc), projects, roles, review and marking groups, control types, and coding dictionaries. External objects are treated in various ways by the “target database”. The target database is the database into which you are uploading the CRF draft spreadsheet. This can be the same database/URL from which the draft spreadsheet was downloaded, or it can be a completely different database/URL. Because the spreadsheet may be uploaded into a different database, some of the external objects referenced in the spreadsheet may not exist in the target database. Understanding the different types of objects will come in handy when uploading spreadsheets into target databases. This will be discussed further in the Errors in the Upload Process section of this manual.



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Worksheet Details in the Spreadsheet The following sections list the contents of each worksheet in the Architect Loader spreadsheet. For complete definitions of each property and how it is built in Architect, refer to the Architect Training Manual. The worksheets are discussed in the order in which they appear in the Architect Loader spreadsheet, although that may not be the order in which they are filled out.

CRF Draft Worksheet The CRF Draft worksheet is arguably the most important worksheet in the spreadsheet. Its contents are used to determine the target location of the spreadsheet’s contents during the upload process. Objects on this page are defined on the CRF Draft or Version main page and the Project or Global Library (GLV) main page in Architect. Refer to the table below for details on the properties displayed on the CRF Draft worksheet:

CRF Draft Worksheet Property Draft Name

Definition User-defined draft identifier. The Draft Name that is entered will be used to determine into which draft the contents of the spreadsheet will be uploaded. For example, if Draft 1.0 is entered as the Draft Name, during the upload process the system will look for Draft 1.0 in whatever project or Global Library Volume (GLV) is identified as the target for upload. If Draft 1.0 does not exist in that target project or GLV it will be created.

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CRF Draft Worksheet Property Delete Existing

Definition If a Project/Draft or GLV/Draft combination exists in the target database and… •

Delete Existing is set to TRUE, then the entire draft in the target database is deleted from the database before the content of the spreadsheet is uploaded. For example, if Draft 1.0 exists in the target, during the upload process Draft 1.0 will be deleted and replaced with the Draft 1.0 contents from the spreadsheet.

•

Project Name

Delete Existing is set to FALSE, then the upload process will merge the spreadsheet content with the existing draft. While merging, the content in the spreadsheet takes precedence and overwrites the draft content. For example, if Draft 1.0 exists in the target, during the upload process the contents of Draft 1.0 in the spreadsheet will be merged with the contents of Draft 1.0 in the project or GLV. If the same object exists in both the spreadsheet and the project/GLV, the object in the project/GLV will be replaced with the object in the spreadsheet.

User-defined project or Global Library Volume (GLV) name. The Project or GLV name that is entered will be used to determine into which project or GLV the contents of the spreadsheet will be uploaded. For example, if Fixaloid is entered as the Project Name, during the upload process the system will look for a Fixaloid project or GLV in the target database. If Fixaloid exists, the contents of the spreadsheet will be uploaded into that project or GLV. If Fixaloid does not exist in the target database, it will be created.



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CRF Draft Worksheet Property Project Type

Definition Indicates whether the content in the spreadsheet is an Architect project or Global Library Volume. The user will select the Project Type from a dropdown list. The Project Type entered will be used to determine whether the spreadsheet contents will be uploaded into a project or into a Global Library Volume. For example, if the Project Name entered is Fixaloid, and the Project Type is Global Library Volume, during the upload process the system will determine if a Global Library Volume (GLV) called Fixaloid exists in the target database. If the GLV Fixaloid exists, the system will then look to see whether the specified Draft Name exists within that GLV, and so on. If the GLV Fixaloid does not exist in the target database it will be created.

Primary Form OID

Indicates which form in the draft will function as the Primary Form The Primary Form OID is selected from a dropdown list containing all Form OIDs, as defined on the Forms worksheet. Selecting a Primary Form OID is optional.

Default Matrix OID

Indicates which matrix in the draft will function as the Default Matrix for the draft. The Default Matrix is selected from a dropdown list containing all Matrix OIDs, as defined on the Matrices worksheet. Selecting a Default Matrix OID is optional.

Confirmation Message

Indicates the user-defined message displayed for endusers when forms are submitted in the EDC module. Entering a Confirmation Message is optional; however, if a Confirmation Message is not entered all forms within the draft will default to a Confirmation Style of “No Link” upon upload.

Signature Prompt

Indicates the user-defined message displayed for the Investigator when entering a signature. Entering a Signature prompt is optional.

Lab Standard Group

Indicates the Standard Group that is specified for the draft. The Standard Group may be selected from a dropdown list of available standard groups that were downloaded from the source database, or a new value can be istyped into the cell. Entering a Lab Standard Group optional.

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CRF Draft Worksheet Property

Definition

Reference Labs

Indicates the Reference Lab that is selected for the draft. The Reference Lab may be selected from a dropdown list of available Reference Labs that were downloaded from the source database, or a new value can be typed into the cell. Entering a Reference Lab is optional.

Alert Labs

Indicates the Alert Lab that is selected for the draft. The Alert Lab may be selected from a dropdown list of available Alert Labs that were downloaded from the source database, or a new value can be typed into the cell. Entering an Alert Lab is optional.

SyncOID Project

User-defined project or Global Library Volume (GLV) name. The Project or GLV name that is entered will be used as the synchronization srcin; you are telling the system to use the OIDs from the project that is defined as the Sync OID Project. Refer to Appendix C of this manual for more information on Synchronizing OIDs.

SyncOIDDraft

User-defined draft identifier. The Draft name that is entered will be used as the synchronization srcin; are to OID use the OIDs from the draftyou that is telling definedthe assystem the Sync Draft. For example, if Fixaloid is entered as the Project Name, during the upload process the system will look for the Fixaloid project in the target database. When the project has been located, the system will look for the draft name in that project. Once the draft has been found, the OIDs from the spreadsheet will update the OIDs in the Fixaloid project. If the system cannot find the project/draft name combination, the transaction will be rolled back. Refer to Appendix C of this manual for more information on Synchronizing OIDs.

SyncOIDProjectType

Indicates whether the synchronization srcin is an Architect project or Global Library Volume. The user will select the Project Type from a dropdown list. Refer to Appendix C of this manual for more information on Synchronizing OIDs.



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CRF Draft Worksheet Property SyncOIDOriginIsVersion

Definition If set to TRUE, indicates that the system will sync to a project or GL version. If set to FALSE, indicates that the system will sync to a project or GL draft. This setting is set to FALSE by default. Refer to Appendix C of this manual for more information on Synchronizing OIDs.

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Forms Worksheet Refer to the table below for details on the properties displayed on the Forms worksheet. The objects are defined on the Forms draft item and the Restrictions draft item within a project or Global Library Volume draft or version.

Forms Worksheet Property

Definition

OID

User-defined unique identifier for a form. Form OID is required.

Ordinal

Position of the form within the list of forms (1-n). Required.

Draft Form Name

User-defined form name (string) displayed for end-users in the EDC module. Form Name is required.

Draft Form Active

If TRUE, form will be set as active. If FALSE, form will be set as inactive. Specified via a dropdown list. If left blank, defaults to FALSE upon upload.

Help Text

User-defined help text, accessible via a “question mark” icon on the form in the EDC module.

Is Template

If TRUE, form will be set as a Template form. If FALSE, form will be set as a standard (non-template) form. Specified via a dropdown list. If left blank, defaults to False upon upload.

Is Signature Required

If TRUE, form will require Investigator signature. If FALSE, form will not require Investigator signature. Specified via a dropdown list. If left blank, defaults to FALSE upon upload.

View Restrictions

Roles, separated by commas, which will not have access to view a form. For example, if the roles CRC and PI should be restricted from viewing a form, the following would be entered: CRC,PI

Entry Restrictions

Roles, separated by commas, which will not have access to enter data into a form. For example, if the roles CRC and PI should be restricted from entering data into a form, the following would be entered: CRC,PI

Log Direction

If Portrait, log form renders vertically. If Landscape, log form renders horizontally. Specified via a dropdown list. If left blank, defaults to Portrait upon upload if the form contains log fields.



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Forms Worksheet Property

Definition

DDE Option

If Must Not DDE, the form is not a DDE form. If May DDE, the form’s DDE-status is dependant on the Site, and if Must DDE, the form is always a DDE form. Specified via a dropdown list. If left blank, defaults to Must Not DDE upon upload.

Confirmation Style

If Link Next, the confirmation message displays with a hyperlink to the next form in the folder. If No Link, the confirmation displays without any hyperlink. If Link Custom, the confirmation message displays with a link to a specified folder/form. Specified via a dropdown list. If left blank, defaults to No Link during upload.

Link Folder OID

If Link Custom is entered for Confirmation Style, Link Folder OID is used to specify the user-defined unique identifier for the custom link folder. Specified via a dropdown list. Required if Confirmation Style is set to Link Custom.

Link Form OID

If Link Custom is entered for Confirmation Style, Link Form OID is used to specify the user-defined unique identifier for the custom link form. Specified via a dropdown list. Required if Confirmation Style is set to Link Custom.

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Fields Worksheet The following properties are displayed on the Fields object worksheet. Objects below are defined within a project or Global Library Volume draft or version.

Fields Worksheet Property Form OID

Definition Indicates on which form the field will reside. Form OID is selected from a dropdown list of forms. The list’s contents are pulled from the Forms worksheet in the spreadsheet. A form must exist on the Forms worksheet in order for its Form OID to exist in the dropdown list on the Fields worksheet. A Form OID selection is required.

Field OID

User-defined unique identifier for the field. Field OID is required.

Ordinal

Position of the field within the form (1-n). Required.

Draft Field Number

User-specified number that displays to the left of the field label on form. For example, the “1.” in the sample field label below. 1. Please enter subject’s initials:

Draft Field Name

User-defined localizable name for the field. Field Name is required.

Draft Field Active

If TRUE, the field is set as active. If FALSE, the field is set as inactive. Selected via a dropdown list. If left blank, defaults to FALSE.

Variable OID

User-defined unique identifier for the variable. Variable OID is required for all fields, with the exception of heading fields.

Data Format

Format in which the data should be entered by the end user. The format entered must be compatible with the control type selected. Required if a Variable OID has been entered.

Data Dictionary Name

User-defined dictionary name (string) displayed in the form builder when specifying which data dictionary to associate with a field. Selected via a dropdown list, whose contents are pulled from the Data Dictionary worksheet in the spreadsheet. A data dictionary must exist on the Data Dictionary worksheet in order for its name to exist in the dropdown list on the Fields worksheet.



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Fields Worksheet Property

Definition

Unit Dictionary Name

User-defined dictionary name (string) displayed in the form builder when specifying which unit dictionary to associate with a field. Selected via a dropdown list, whose contents are pulled from the Unit Dictionary worksheet in the spreadsheet. A unit dictionary must exist on the Unit Dictionary worksheet in order for its name to exist in the dropdown list on the Fields worksheet.

Coding Dictionary

Name of the coding dictionary associated with the field. Specified via a dropdown list, or can be manually entered. If the dictionary selected does not exist in the target database, an error will be flagged during the upload process and the spreadsheet’s contents (in their entirety) will not be uploaded.

Control Type

The data control used by the end-user when entering data in the EDC module. Specified via a dropdown list. A Control Type selection is required.

Acceptable File Extensions

Indicates what file types may be uploaded into the specified field. Control Type selected must be File Upload if Acceptable File Extensions are entered. Each extension should be entered in its 3-character format, separated by commas. For example, the following might be entered: jpg,bmp,png. Entries must not conflict with file types that are forbidden for upload, as specified in the target database’s Configuration module.

Indent Level

Indicates whether the field should be indented from the left margin (0, 1, 2). If left blank, defaults to 0.

Pre Text

User-defined field label displayed to end-users in the EDC module.

Fixed Unit

User-defined helpful text displayed to the right of the data entry control on the form in the EDC module.

Header Text

User-defined short version of Pre Text (field label), used as a column heading for log fields when displayed in landscape mode.

Help Text

User-defined help text, accessible via a “question mark” icon displayed next to a field in the EDC module.

Source

If TRUE, indicates that the field requires source document

Document

verification. If FALSE, indicates that no verification is required for the field. Specified via a dropdown list. If left blank, defaults to FALSE.

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Definition

Is Log

If TRUE, indicates that the field is a log field. If FALSE, indicates that the field is a standard (non-log) field. Specified via a dropdown list. If left blank, defaults to FALSE.

Default Value

User-defined value displayed in a field by default for the enduser in the EDC module.

SAS Label

User-defined SAS Label.

SAS Format

User-defined SAS Format.

Is Required

If TRUE, a query is fired when the field is submitted blank in the EDC module. If FALSE, field is not required and may be submitted blank. Specified via a dropdown list. If left blank, defaults to FALSE.

Query Future Date

If TRUE, a query is fired when a date in the future is submitted in the EDC module. If FALSE the field accepts future dates. Specified via a dropdown list. If left blank, defaults to FALSE.

Is Visible

If TRUE, the field is set as visible. If FALSE, the field is set as invisible. Specified via a dropdown list. If left blank, defaults to FALSE.

Is Translation Required

If TRUE, the field is set to require translation in the EDC module. If FALSE, the field does not require translation. Specified via a dropdown list. If left blank, defaults to FALSE.

Analyte Name

Analyte which is associated to the field. Specified via a dropdown list.

Is Clinical Significance

If TRUE, indicates that clinical significance is required for the specified Analyte. If FALSE, indicates that clinical significance is not required. Specified via a dropdown list. If left blank, defaults to FALSE.

Query Nonconformance

If TRUE, indicates that a query message should display when non-conformant data is entered in the EDC module. If FALSE, indicates that no query message should display. Specified via a dropdown list. If left blank, defaults to FALSE.

Other Visits

If TRUE, indicates that the field will display previous visit data in the EDC manual. If FALSE, indicates that no previous visit data will display. Specified via a dropdown list. If left blank, defaults to FALSE.



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Definition

Can Set Record Date

If TRUE, indicates that the date entered into the field will be set as the Record Date. If FALSE, indicates that the entered date will not be used as the Record Date. Specified via a dropdown list. If left blank, defaults to FALSE.

Can Set Data Page Date

If TRUE, indicates that the date entered into the field will be set as the Data Page Date. If FALSE, indicates that the entered date will not be used as the Data Page Date. Specified via a dropdown list. If left blank, defaults to FALSE.

Can Set Instance Date

If TRUE, indicates that the date entered into the field will be set as the Instance Date. If FALSE, indicates that the entered date will not be used as the Instance Date. Specified via a dropdown list. If left blank, defaults to FALSE.

Can Set Subject Date

If TRUE, indicates that the date entered into the field will be set as the Subject Date. If FALSE, indicates that the entered date will not be used as the Subject Date. Specified via a dropdown list. If left blank, defaults to FALSE.

Does Not Break Signature

If TRUE, indicates that the calculation or re-calculation of the value in the derived field will not break the Investigator signature. If FALSE, indicates that the calculation or recalculation of the value in the derived field will break the Investigator signature. Specified via a dropdown list. If left blank, defaults to FALSE. Applies only to derived fields.

Lower Range

User-enter value indicating the lowest value that may be entered into the field in EDC that will not cause a query to be fired.

Upper Range

User-entered value indicating the highest value that may be entered into the field in EDC that will not cause a query to be fired.

NC Lower Range

User-enter value indicating the lowest value that may be entered into the field in EDC that will not cause the field status to be set as non-conformant.

NC Upper Range

User-entered value indicating the highest value that may be entered into the field in EDC that will not cause the field status to be set as non-conformant.

View Restrictions

Roles, separated by commas, which will not have access to view a field. For example, “CRC,PI”

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Definition

Entry Restrictions

Roles, separated by commas, which will not have access to enter data into a field. For example, “CRC,PI”

Review Groups

Review group names, separated by commas, which will be flagged to conduct review for the field. For example, “CRC,PI”

Is Visual Verify

If TRUE, indicates that the field will function as a Visual Verify field in second-pass for any sites that use Double-Data Entry (DDE). If FALSE, indicates that the field is not a visual verify field. Specified via a dropdown list. If left blank, defaults to FALSE. Applies only to fields on DDE forms.



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Folders Worksheet The following properties are displayed on the Folders object worksheet. Objects on this page are defined on the Folders draft item page within a project or Global Library Volume draft or version.

Folders Worksheet Property

Definition

OID

User-defined unique identifier for the folder. OID is required.

Ordinal

Position of the folder within the list of folders (1-n). Required.

Folder Name

User-defined folder name (string) displayed for end-users in the EDC module. Folder Name is required.

Access Days

Number of days prior to the target date that the folder may be accessed by the end-user in the EDC module.

Start Win Days

Number of days prior to the target date that the end-user should start entering data into the folder in the EDC module.

Target Days

Ideal number of days after time zero that the end-user should be entering data into the folder in the EDC module.

End Win Days

Number of days after the target date that the end-user should be done entering data into the folder in the EDC module.

Overdue Days

Number days after the target date that data not entered into the folderofshould be flagged as overdue and appear in the enduser’s task summary in the EDC module.

Close Days

Number of days after the target that the folder should no longer be accessible to the end-user for data entry in the EDC module.

Parent Folder OID

User-defined identifier for the parent folder of the specified folder. Specified via a dropdown list.

Is Reusable

If TRUE, indicates that the folder is a reusable folder. If FALSE, indicates that the folder cannot be reused. If left blank, defaults to FALSE. Specified via a dropdown list.

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Data Dictionaries Worksheet The following properties are displayed on the Data Dictionaries object worksheet. Objects on this page are defined on the Data Dictionaries draft item page within a project or Global Library Volume draft or version.

Data Dictionary Worksheet Property

Definition

Data Dictionary

User-defined dictionary name (string) displayed in the form

Name

builder when specifying which dictionary to associate with a field. Dictionary Name is required.

Data Dictionary Entries Worksheet The following properties are displayed on the Data Dictionary Entries object worksheet. Objects on this page are defined within a dictionary on the Data Dictionaries draft item page within a project or Global Library Volume draft or version.

Data Dictionary Entries Worksheet Property

Definition

Data Dictionary Name

User-defined dictionary name (string) displayed in the form builder when specifying which dictionary to associate with a field. Selected via a dropdown list, whose contents are pulled from the Data Dictionary worksheet in the spreadsheet. A data dictionary must exist on the Data Dictionary worksheet in order for its name to exist in the dropdown list on the Data Dictionary Entries worksheet. Data Dictionary Name is required.

Coded Data

User-defined database entry for the field. Coded Data is required.

Ordinal

The position of the data dictionary entry within the list of entries (1-n). Required.

User Data String

User-defined dictionary entry text displayed for the end-user in the EDC module. User Data String is required.

Specify

If TRUE, indicates the entry should contain a specify text box. If FALSE indicates the field will not contain a specify text box. Specified via a dropdown list. If left blank, defaults to FALSE.



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Unit Dictionaries Worksheet The following properties are displayed on the Unit Dictionary object worksheet. Objects on this page are defined on the Unit Dictionaries draft item page within a project or Global Library Volume draft or version.

Unit Dictionary Worksheet Property Unit Dictionary Name

Definition User-defined dictionary name (string) displayed in the form builder when specifying which unit dictionary to associate with a field. Unit Dictionary Name is required.

Standard Unit Name

Indicates which entry in the unit dictionary is the standard unit for the dictionary. Specified via a dropdown list based on the Coded Units entered for the dictionary on the Unit Dictionary Entries worksheet. A Coded Unit must exist on the Unit Dictionary Entries worksheet in order to appear in the dropdown list on the Unit Dictionaries worksheet.

Unit Dictionary Entries Worksheet: The following properties are displayed on the Unit Dictionary Entries object worksheet. Objects on this page are defined within a unit dictionary on the Unit Dictionaries draft item page within a project or Global Library Volume draft or version.

Unit Dictionary Entries Worksheet Property

Definition

Unit Dictionary Name

User-defined dictionary name (string) displayed in the form builder when specifying which unit dictionary to associate with a field. Selected via a dropdown list, whose contents are pulled from the Unit Dictionary worksheet in the spreadsheet. A unit dictionary must exist on the Unit Dictionary worksheet in order for its name to exist in the dropdown list on the Unit Dictionary Entries worksheet. Unit Dictionary Name is required.

Coded Unit

User-defined database entry for the field.

Ordinal

The position of the unit dictionary entry within the list of entries (1-n). Required.

Constant A

A constant in the following formula: Standard Value = Constant A / Constant B (User Value + Constant C) + Constant K

Constant B

A constant in the following formula: Standard Value = Constant A / Constant B (User Value +

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Unit Dictionary Entries Worksheet Property

Definition Constant C) + Constant K

Constant C


Constant K


Unit String

User-defined unit dictionary entry text displayed for the enduser in the EDC module.



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Matrices Worksheet The following properties are displayed on the Matrices object worksheet. Objects on this page are defined on the Matrices draft item page within a project or Global Library Volume draft or version.

Matrices Worksheet Property

Definition

Matrix Name

User-defined matrix name (string). Matrix Name is required.

OID

User-defined unique identifier for the matrix. Matrix OID is required.

Addable

If TRUE, indicates that the matrix can be added to the default matrix via an Add Event dropdown list in the EDC module. Specified via a dropdown list. If left blank, defaults to FALSE.

Maximum

Indicates the maximum number of times a matrix may be added (0-n).

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MatrixN#OID Worksheet The following properties are displayed on the MatrixN#OID object worksheet. Objects on this page(s) are defined within a matrix in the Matrices draft item page within a project or Global Library Volume draft or version. A new worksheet must be created for each matrix. New worksheets can be created using Excel tools.

MatrixN#OID Worksheets Property

Definition

MatrixN#OID (worksheet tab text)

In the tab name, the matrix OID is indicated after a numeric matrix identifier. For example: Matrix1#DEFAULT Matrix2#ADEVENTS Matrix3#CONMEDS Inside the worksheet, Form OIDs are listed in the first column and Folder OIDs are listed in the first row, similar to the display in the Matrices draft item within Architect. An “X” indicates that the specified form is found within the specified folder. The “X” may be selected from a dropdown list. If new forms or folders are added to their respective worksheets, their OIDs must be manually added to the MatrixN#OID worksheet(s).

Subject

The default folder “Subject” is added to each matrix by default.



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Checks Worksheet The following properties are displayed on the Checks object worksheet. Objects on this page are defined in the Edit Checks draft item page within a project or Global Library Volume draft or version.

Checks Worksheet Property

Definition

Check Name

User-defined edit check name (string). Check Name is required.

Check Active

If TRUE, indicates that the edit check is active. If FALSE, indicates that the edit check is inactive. Specified via a dropdown list. If left blank, defaults to TRUE.

Bypass During Migration

If TRUE, indicates that the edit check will be bypassed during CRF Migration. If FALSE, indicates that the edit check will run during CRF Migration. Specified via a dropdown list. If left blank defaults to FALSE.

Infix

Edit check steps and actions converted from post-fix notation format into “plain English” infix notation format. Text entered here is ignored during the upload process.

Copy Source

Indicates the project or Global Library Volume (GLV) details of the source from which you copied. The format of the entry in this cell will be: Project Type: Indicates if the copy source was a Project or a Global Library volume Draft Type: Indicates if the copy source was a project Draft or a project Version Text entered here is ignored during the upload process. If the edit check was not copied using the Global Library, this cell will be blank. Refer to the Architect Training Manual for more information.

Needs Retesting

If TRUE, the edit check was flagged as needing retesting after a Global Library copy. If FALSE, the edit check will function correctly as long as it was properly tested in the copy source. Specified via a dropdown list. Text entered here is ignored during the upload process. Refer to the Architect Training Manual for more information.

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Checks Worksheet Property Retesting Reason

Definition Indicates the reason why the edit check needs to be retested. If the corresponding Needs Retesting value for the object is set to TRUE, a Retesting Reason will be specified. If the Needs Retesting value is set to FALSE, a reason is not specified and the cell is left blank. Common messages include: •

•

Uses wildcarded form references Possible issues in matrix environment for the following forms

•

Target has been changed since the time of copy

•

Source has been changed since the time of copy

•

Contains AddMatrix or MergeMatrix actions

Text entered here is ignored during the upload process. Refer to the “Architect Training Manual for more information.

Check Steps Worksheet The following properties are displayed on the Check Steps object worksheet. Objects on this page are defined in an edit check on the Edit Checks draft item page within a project or Global Library Volume draft or version.

Check Steps Worksheet Property

Definition

Check Name

User-defined edit check name (string). Selected via a dropdown list, whose contents are pulled from the Checks worksheet in the spreadsheet. A check must exist on the Checks worksheet in order for its name to exist in the dropdown list on the Check Steps worksheet. Check Name is required.

Step Ordinal

The position of the check step within the list of check steps for the edit check (1-n). Required.

Check Function

Indicates the check function (if any) used in the check step. Selected a dropdown list of pre-defined entries.

Static Value

Indicates the constant (if any) used in the check step.



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Check Steps Worksheet Property Data Format

Definition If a constant is entered, Indicates the format of that constant. If a Variable OID is entered, the user must enter one of the following values, as specified: •

StandardValue

•

UserValue

•

•

CodedValue DataStatus

•

DataPoint

Variable OID

Indicates the variable (if any) associated with the check step. Specified via a dropdown list. The dropdown contents are based on the Variable OIDs defined on the Fields worksheet.

Folder OID

Indicates the folder (if any) associated with the check step. Selected via a dropdown list. The dropdown contents are based on the Folder OIDs defined on the Folders worksheet.

Form OID

Indicates the form (if any) associated with the check step. Selected via a dropdown list. The dropdown contents are based on the Form OIDs defined in the Forms worksheet.

Field OID

Indicates the field (if any) associated with the check step. Selected via a dropdown list. The dropdown contents are based on the Field OIDs defined in the Fields worksheet.

Record Position

Indicates the record position (if any) associated with the check step.

Custom Function

Indicates the custom function (if any) referenced in the check step. Selected from a dropdown list. The dropdown contents are based on the Custom Function Names defined on the Custom Functions worksheet.

Logical Record Position

Indicates the logical record position (if any) associated with the derivation step. Selected from a dropdown list of pre-defined options.

Form Repeat Number

Indicates the repeat number (if any) for the form referenced in the check step (0-n).

Folder Repeat Number

Indicates the check the steprepeat (0-n).number (if any) for the folder referenced in

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Check Actions Worksheet The following properties are displayed in the Check Actions object worksheet. Objects on this page are defined in the Edit Checks draft item page within a project or Global Library Volume draft or version. Certain Edit Check Actions have additional options that a user must enter in order to execute the edit check successfully. To learn more about these options and the keywords that the user must enter into the spreadsheet for a successful upload, please see the Edit Check Actions section in this chapter.

Check Actions Worksheet Property

Definition

Check Name

User-defined edit check name (string). Specified via a dropdown list. Selected via a dropdown list, whose contents are pulled from the Checks worksheet in the spreadsheet. A check must exist on the Checks worksheet in order for its name to exist in the dropdown list on the Check Steps worksheet. Check Name is required.

Folder OID

Indicates the folder (if any) associated with the check action. Selected via a dropdown list. The dropdown contents are based on the Folder OIDs defined on the Folders worksheet.

Form OID

Indicates the form (if any) associated with the check action. Selected via a dropdown list. The dropdown contents are based on the Form OIDs defined in the Forms worksheet.

Field OID

Indicates the field (if any) associated with the check action. Selected via a dropdown list. The dropdown contents are based on the Field OIDs defined in the Fields worksheet.

Variable OID

Indicates the variable (if any) associated with the check action. Specified via a dropdown list. The dropdown contents are based on the Variable OIDs defined on the Fields worksheet.

Record Position

Indicates the record position (if any) associated with the check action.

Page Repeat Number

Indicates the repeat number (if any) for the form referenced in the check action (0-n).

Instance Repeat Number

Indicates the repeat number (if any) for the folder referenced in the check action (0-n).-

Action Type

Indicates the check action to be performed when the check is fired. Specified via a dropdown list of pre-defined options.

Action String

Indicates the text (if any) displayed to the end-user as a result of the check action.



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Check Actions Worksheet Property

Definition

Action Options

Additional options that the user is required to enter in order for the edit check to execute successfully. Refer to the table below for details.

Action Script

The string or message that may be required when building a check action.

Certain edit checks actions have additional options that the user is required to enter in order for the edit check to execute successfully. The following table describes those options and the keywords that the user must enter into the spreadsheet to ensure a successful upload. Note:

48



Items within quotes must be entered verbatim, excluding the quotes.



If more than one option is required for a check action, separate the options with a delimiter (i.e. comma (,), pipe (|), etc.) The delimiter is configured for the workbook using the menu path File | Properties | Custom…. The default delimiter is a comma (,).



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Architect Settings

Spreadsheet Entries

Edit Check Action

Options

Action Options

Action String

Add Comment

Message

--

User-defined message

Add Deviation

Deviation Code

Deviation Code (required)


Deviation Class

Deviation Class (required)

Message

Separated by a delimiter Example: B,20

Add Form

Form Name

Form OID

--

Add Matrix

Matrix Name

Matrix OID

--

Custom Function

Custom Function Name


--

Merge Matrix

Matrix Name

Matrix OID

--

Open Query

Marking Group

Marking Group Name (required)


Requires Response (checkbox) Requires Manual Close (checkbox) Query Message

“RequiresResponse” “RequiresManualClose” Separate items with a delimiter Example: CRC,RequiresResponse

Place Sticky

Marking Group Sticky Message


Marking Group Name (required)



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Architect Settings

Spreadsheet Entries

Edit Check Action

Options

Action Options

Action String

Requires Review

Review Group

Review Group Name (required)

--

If multiple, separate with a delimiter Example: DM,Safety Requires Verification

--

--

--

Send Message

Target Type (Role, User, User Group)

Target: enter only one (required)


Target

“Role”=Role Name

Urgency

“User”=Username

Message

“UserGroup”=User Group Name Urgency: enter only one (required) “Urgency”=”high” or “normal” or “low” Separate items with a delimiter Example: Role=Safety,Urgency=High

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Architect Settings

Spreadsheet Entries

Edit Check Action

Options

Action Options

Action String

Set Datapoint

Don’t Enter Empty if False (checkbox)

Enter one:

User-defined value

Value

“EnterEmptyIfFalse” “DontEnterEmptyIfFalse”

Set Subject Name

--

--

--

Set Subject Status

Subject Status

Enter one:

--

“FromDataValue” Subject Status Example: Enrolled Example: FromDataValue Set Time Forward

--

--

--

Set Time Zero

--

--

--

Set Non Conformant

--

--

--

Use Name String (checkbox)

Enter one:

Name String

Name String

“true”

Update Folder Name

“false” Update Form Name

Use Name String (checkbox)

Enter one:

Name String

“true”

Name String

“false”



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Architect Settings

Spreadsheet Entries

Edit Check Action

Options

Action Options

Action String

Set Secondary Subject Name

--

--

--

Set Data Point Visible

Visible (checkbox)

Enter one:

--

“true” “false” Set Form Requires Signature

--

--

--

Set Folder Requires Signature

--

--

--

Set Subject Requires Signature

--

--

--

Set Dynamic Search List



--

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Derivations Worksheet The following properties are displayed on the Derivations object worksheet. Objects on this page are defined in the Derivations draft item page within a project or Global Library Volume draft or version.

Derivations Worksheet Property Derivation Name

Definition User-defined derivation name (string). Derivation Name is required.

Active

If TRUE, indicates that the derivation is active. If FALSE, indicates that the derivation is inactive. Specified via a dropdown list. If left blank, defaults to TRUE.

Folder OID

Indicates the folder (if any) associated with the derivation’s Apply To Variable. Specified via a dropdown list. The dropdown contents are based on the Folder OIDs defined on the Folders worksheet.

Form OID

Indicates the form associated with the derivation’s Apply To Variable. Specified via a dropdown list. The dropdown contents are based on the Form OIDs defined on the Forms worksheet.

Field OID

Indicates the field (if any) associated with the derivation’s Apply To Variable. Specified via a dropdown list. The dropdown contents are based on the Field OIDs defined on the Fields worksheet.

Variable OID

Indicates the variable associated with the derivation’s Apply To Variable. Specified via a dropdown list. The dropdown contents are based on the Variable OIDs defined on the Fields worksheet.

Record Position

Indicates the record position (if any) associated with the derivation’s Apply To Variable.

All Variables In Folders

If TRUE, indicates that the derivation should be applied to all instances of the variable within all fields in all folders. If FALSE, indicates that the derivation should be applied only to the specified field/variable. Specified via a dropdown list. If left blank, defaults to FALSE.

All Variables in Fields

If TRUE, indicates that the derivation should be applied to all instances of the variable within all fields in a specified folder. If FALSE, indicates that the derivation should be applied only to the specified field/variable. Specified via a dropdown list. If left blank, defaults to FALSE.



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Derivations Worksheet Property

Definition

Form Repeat Number

Indicates the repeat number (if any) for the form containing the variable to which the derivation should be applied (0-n).

Folder Repeat Number

Indicates the repeat number (if any) for the folder containing the variable to which the derivation should be applied (0-n).

Bypass During

If TRUE, indicates that the derivation will be bypassed during

Migration

CRF Migration. If FALSE, indicates that the derivation will run during CRF Migration. Specified via a dropdown list. If left blank, defaults to FALSE.

Copy Source

Indicates the project or Global Library Volume (GLV) details of the source from which you copied. The format of the entry in this cell will be: Project Type: Indicates if the copy source was a Project or a Global Library volume Draft Type: Indicates if the copy source was a project Draft or a project Version Text entered here is ignored during the upload process. If the derivation was not copied using the Global Library, this cell will be blank. Refer to the Architect Training Manual for more information.

Needs Retesting

If TRUE, the derivation was flagged as needing retesting after a Global Library copy. If FALSE, the derivation will function correctly as long as it was properly tested in the copy source. Specified via a dropdown list. Text entered here is ignored during the upload process. Refer to the Architect Training Manual for more information.

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Derivations Worksheet Property Retesting Reason

Definition Indicates the reason why the derivation needs to be retested. If the corresponding Needs Retesting value for the object is set to TRUE, a Retesting Reason will be specified. If the Needs Retesting value is set to FALSE, a reason is not specified and the cell is left blank. Common messages include: •

•

Uses wildcarded form references Possible issues in matrix environment for the following forms

•

Target has been changed since the time of copy

•

Source has been changed since the time of copy

Text entered here is ignored during the upload process. Refer to the Architect Training Manual for more information.

Derivation Steps Worksheet: The following properties are displayed on the Derivations object worksheet. Objects on this page are defined within a derivation on the Derivations draft item page within a project or Global Library Volume draft or version.

Derivation Steps Worksheet Property

Definition

Derivation Name

User-defined derivation name (string). Selected via a dropdown list, whose contents are pulled from the Derivations worksheet in the spreadsheet. A derivation must exist on the Derivations worksheet in order for its name to exist in the dropdown list on the Derivation Steps worksheet. Derivation Name is required.

Step Ordinal

The position of the derivation step within the list of derivation steps for the derivation (1-n). Required.



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Derivation Steps Worksheet Property Data Format

Definition If a constant is entered, indicates the format of that constant. If Variable OID is entered, the user must enter one of the following values (verbatim): •

StandardValue

•

UserValue

•

•

CodedValue DataStatus

•

DataPoint

Variable OID

Indicates the variable (if any) associated with the derivation step. Specified via a dropdown list. The dropdown contents are based on the Variable OIDs defined on the Fields worksheet.

Step Value

Indicates the constant (if any) used in the derivation step.

Step Function

Indicates the step function (if any) used in the derivation step. Specified via a dropdown list of pre-defined options.

Folder OID

Indicates the folder (if any) associated with the derivation step. Specified via a dropdown list. The dropdown contents are based on the Folder OIDs defined on the Folders worksheet.

Form OID

Indicates the form (if any) associated with the derivation step. Specified via a dropdown list. The dropdown contents are based on the Form OIDs defined in the Forms worksheet.

Field OID

Indicates the field (if any) associated with the derivation step. Specified via a dropdown list. The dropdown contents are based on the Field OIDs defined in the Fields worksheet.

Custom Function

Indicates the custom function (if any) referenced in the derivation step. Specified via a dropdown list. The dropdown contents are based on the Custom Function Names defined on the Custom Functions worksheet.

Record Position

Indicates the record position (if any) associated with the derivation step.

Logical Record Position

Indicates the logical record position (if any) associated with the derivation step. Specified via a dropdown list of pre-defined options.

Form Repeat Number

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Indicates the repeat number (if any) for the form referenced in the derivation step (0-n).



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Derivation Steps Worksheet Property Folder Repeat Number

Definition Indicates the repeat number (if any) for the folder referenced in the derivation step (0-n).



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Lab Variable Mappings The following properties are displayed on the Lab Variable Mappings object worksheet. Objects on this page are defined within the Lab Settings draft item within a project or Global Library Volume draft or version.

Lab Variable Mappings Worksheet Property

Definition

Global Variable

Indicates the name of the Global Variable used in a range type

OID

within the draft.

Form OID

Indicates the form on which the Global Variable’s project/GLVbased counterpart exists in the target draft. The dropdown contents are based on the Form OIDs defined in the Forms worksheet.

Field OID

Indicates the Global Variable’s project/GLV-based counterpart field that exists in the target draft. The dropdown contents are based on the Field OIDs defined in the Fields worksheet.

Folder OID

Indicates the folder (if any) in which the form containing the project/GLV-based Global Variable counterpart field resides. The dropdown contents are based on the Folder OIDs defined on the Folders worksheet.

Location Method

Indicates the location of the specified Global Variable. Selected from a dropdown list of pre-defined options.

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Custom Functions Worksheet The following properties are displayed in the Custom Functions object worksheet. Objects on this page are defined in the Custom Functions draft item page within a project or Global Library Volume draft or version.

Custom Functions Worksheet Property

Definition

Function Name

User-defined custom function name (string). Name is required.

Source Code

User-defined C#, Visual Basic or SQL code.

Lang

The language in which the source code is written. Specified via a dropdown list of pre-defined options.



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Example: Adding a New Form, Field, and Dicti onary The following example will demonstrate how to edit the spreadsheet. In the example, we will add a new form, “Demography” to the spreadsheet. The Demography form will include one field, “RACE1”, which will use a new data dictionary called “Race”. 1. First we need to determine the order in which we are going to build the objects into the spreadsheet. Once we do that we can start building. We know the following dependencies exist: 

Form OID is a property of a field, so we should build the form before we build the field.



Data Dictionary is a property of field, so we should build the data dictionary before we build the field.



Data Dictionary is a property of the data dictionary entries, so we should build the data dictionary before we build the entries.



Based on the above, we should build our Form, then our Data Dictionary, then our Entries, then our Field.

2. Building the form: on the Forms worksheet, we enter the new form OID, and all of its properties in their respective columns.

3. Building the data dictionary: on the Data Dictionary worksheet, we enter the new dictionary name.

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4. Building the dictionary entries: on the Data Dictionary Entries worksheet, we use the Dictionary Name dropdown list to select the Race dictionary, and enter the entry properties into their respective columns. Each entry is entered into its own line, each line referencing the Race dictionary.

5. Building the field: on the Fields worksheet, we use the Form OID dropdown list to select the Demography form, on which the Race field will reside, and enter all the properties for the field in their respective columns. In the Data Dictionary Name column, we select the Race dictionary from the dropdown list.

6. Save the changes using Excel workbook tools (File | Save).



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Editing or Deleting Data (Protected Worksheets) When editing or deleting data from a spreadsheet, you may encounter “protected” worksheets. To prevent inadvertent edits and unwanted deletions, worksheets within the Architect Loader spreadsheet may be protected. The system will display the message below if you attempt to edit or delete a protected worksheet.

Worksheets can be unprotected using the Excel menu path: Tools | Protection | Unprotect Sheet. Once unprotected, the worksheet can be edited as needed. Note that worksheet cells may display a green triangle in their upper left corner. This is a warning from Excel that numeric values may be stored as text. You can ignore this warning.

Note: Keep data dependencies in mind when editing or deleting data. For example, if

you delete a form, you need to also delete all fields on that form. You also need to edit all matrices to remove references to that form, as well as any edit checks and derivations that relate to that form. Luckily, even if we forget to delete dependencies the system will remind us. When we attempt to upload a file if there are dangling object references – such as references to deleted items – we will get detailed error messages letting us know exactly where those errors exist.

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Note: Worksheets can be downloaded without being protected. If the Protect

Worksheets checkbox, on the Summary/Download page, is checked, then the worksheets will be protected. If the Protect Worksheets checkbox is unchecked, then the worksheets will be un-protected.



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Uploading a Draft This chapter will cover the following topics:

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

The Upload Process



Uploading a Draft Spreadsheet



Understanding the Upload Progress Page



Warnings in the Upload Process



Errors in the Upload Process



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The Upload Process An Architect Draft spreadsheet can be uploaded into the Architect module for various results. 

A spreadsheet can be uploaded into the same database from which it was extracted to update an existing draft of a project or Global Library Volume.



A spreadsheet can be uploaded into the same database from which it was extracted to update an existing project or Global Library Volume with a new draft.



A spreadsheet can be uploaded into the same database from which it was extracted to create a new project or Global Library Volume with a new draft.



A spreadsheet can be uploaded into a separate Rave database to update an existing draft of a project or Global Library Volume.



A spreadsheet can be uploaded into a separate Rave database to create existing draft, or create a new one.

At this point in our process, we have downloaded our draft spreadsheet and made the desired edits. We’re now almost ready to upload our spreadsheet back into a Rave database.

Step #

Description

1


2


3


4


5


If we have not already, we now need to make sure that we update our CRF Draft worksheet within our draft spreadsheet. As mentioned earlier, the CRF Draft worksheet tells the system where the contents of the spreadsheet will be uploaded. 

The Project Type column indicates if the system will upload the draft into a Project or Global Library Volume.



The Project Name column indicates the name of the Project or Global Library Volume into which the contents will be uploaded. If the Project or Global Library Volume does not exist in the target database it will



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be created. The Draft Name column indicates the name of the draft into which the contents will be uploaded, within the specified Project or Global



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Library Volume. If the draft does not exist in the target database it will be created.

Note: The contents of the CRF Draft worksheet are the ONLY way the system

knows where to put the draft in the target database. The name of the excel file is irrelevant to this process. Once the CRF Draft worksheet contents have been edited, we can then conduct the upload process. The upload process updates the objects in a CRF draft with the data on the spreadsheet. Once a draft is uploaded it can be maintained through the Architect module. There are three types of upload. The system determines which type of upload to perform based on the value entered in the Delete Existing column on the CRF Draft worksheet, and whether or not the Project, Global Library Volume, or Draft listed in the spreadsheet already exists in the target database. 

Overwrite: If a Project/Draft or Global Library Volume/Draft combination exists in the target database and Delete Existing is set to TRUE, the existing draft in the target database is deleted and replaced with the content of the spreadsheet.



Draft Merge: If a Project/Draft or Global Library Volume/Draft combination exists in the target database and Delete Existing is set to FALSE, the spreadsheet content is merged into the data that already exists in the database. During this merge, content in the spreadsheet takes precedence and overwrites the draft content.



New Draft Creation: If a Project or Global Library Volume exists in the target database, but the specified Draft does not exist within that Project or Global Library volume, the system will create a new draft in the specified Project or Global Library Volume. If the Project or Global Library does not exist in the target database, the system will create a new Project or Global Library Volume and Draft in the target database. In either case, the Delete Existing flag is ignored because the draft does not exist.

Note: The type of upload is not determined by the user. The system determines the

upload type by examining the content of the CRF Draft spreadsheet and the data in the target database.



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Uploading a Draft Spreadsheet According to our Architect Loader process, now that we’ve entered the required information on the CRF Draft worksheet, we’re ready to Upload our spreadsheet into the database.

Step #

Description

1


2


3


4


5


Spreadsheets are uploaded on the Architect main page, not within a specific project/Global Library Volume or draft.

Note: Data on the spreadsheet is uploaded into the specified locale on the

spreadsheet. The locale for the spreadsheet is a custom property defined for the file (in Excel, File | Properties | Custom).

To Upload a Spreadsheet into a Rave Database: 1. Navigate to the Architect module within Rave by clicking on the Architect link on the sidebar of the Rave homepage.

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2. In the sidebar of the Architect main page, click Upload Draft. The link is only displayed to users with the Architect Security permission, Upload.

3. The Upload Draft page is displayed. Click the Browse button to search for and locate the spreadsheet file that will be uploaded. Note that files can be compressed (.zip).

4. Once the file has been located and selected, the path to the file is displayed in the Selected File textbox. If desired, check the Save Upload History for Roll-Back box. This box is checked by default. If checked, the system will make a backup copy of the target draft prior to the upload. This only applies if the target draft already exists in the target database. Refer to the Restoring Drafts section in this manual for additional information.



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5. Click Upload to begin the uploading process. The system begins the upload and a process page displays the progress. A progress bar indicates the status of each object as it is uploaded, and an event log displays a summary of items as they are updated. Refer to the next section of the manual for details about the contents of the progress page.

6. When the upload is complete, the upload transaction will either be saved to the database or rolled-back (not saved). A message indicating that the transaction was saved or rolled-back is displayed at the top of the screen. For additional information, refer to the next section of the manual.

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Understanding the Upload Progress Page During the upload process, the system displays a progress page to indicate the status of the upload. A progress bar indicates the status of each object as it is uploaded. Above the progress bar, text is displayed indicating what action the system is taking, and when the upload is complete, the text will indicate whether the upload was successful or rolled back.

A list of spreadsheet object-types is displayed on the left-hand side of the screen. Icons indicate the status of each object that is being uploaded: 

A clock icon indicates an object type that is yet to be uploaded



A checkmark icon indicates that the object type has uploaded successfully



A non-conformant icon indicates that the object type encountered an error

The right-side of the screen displays an event log, which contains a summary of items as they are updated.

To stop the upload process at any time during the upload process, click the Abort button at the bottom left corner of the page. The upload stops and any data that has already been processed is rolled back.



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When a successful upload occurs, all objects that were uploaded display the checkmark icon, and the event log includes any warnings and any non-rollback events.

Note: When using Internet Explorer, occasionally an object type’s status icon may

display a “clock” icon instead of a checkmark, even if the object type was successfully uploaded. This is due to an issue with Internet Explorer. While Architect Loader does work with all browsers, we recommend using Mozilla Firefox to ensure that the status icons display correctly. A rollback event is any issue found In in the the spreadsheet that will from saving the uploaded content. case of a rollback, no prevent changesthe aresystem made to the target draft. Refer to the Errors in the Upload process section of this manual for additional information. Non-rollback events are system warnings; a spreadsheet can be saved to the target database if warnings exist, however they are noteworthy and thus are mentioned in the event log. Refer to the Warnings in the Upload Process section of this manual for additional information. Click the Copy to Clipboard link below the event log to copy the text in the event log to the system clipboard. Text in the clipboard may be pasted into another application using standard keyboard shortcuts from the operating system.

If desired, click the Back button to return to the Architect Loader upload page.

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Note: When a rollback occurs, the Event Log and the Copy to Clipboard link do not

display. The log is irrelevant because no modifications occurred in the database.



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Warnings in the Upload Process During the upload process, the system checks the validity of the data for each object entered into the spreadsheet using the same validation rules as in Architect. During the validation process, the system may encounter certain specifications that result in warnings; warnings are listed in the event log but do not cause a transaction rollback. A successful upload can occur with or without warnings.

The following are some common conditions which generate warnings -- listed in the event log -- but do not cause a transaction rollback: 

If a Review Group specified for a field does not exist in the target database the system does not load that Review Group.



If a Role specified for a field view and/or entry restriction does not exist in the target database, the system does no load the view or entry restriction for that Role.



If a draft is uploaded without a default matrix.



If an empty dictionary is uploaded.



If a project or Global Library Volume is created during the upload process.



If a draft for the project or Global Library Volume is created via the upload.

These conditions result in warnings because the spreadsheet does not contain enough information to completely define these objects in the target database. For example, a draft can be uploaded without a default matrix. The system provides a warning for this because although a draft can be created and uploaded without a default matrix, that draft cannot be published without first defining a default matrix.

Note: Objects with incomplete identity definitions are ignored and do not cause

rollback or warnings. For example, if a Form is entered into the spreadsheet but the Form OID is left blank, that form is considered to have an “incomplete identity”. That row in the spreadsheet is ignored. This is useful if you do not want to delete an item from the spreadsheet but you do not want to upload it either.

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Errors in the Upload Process During the upload process, the system checks the validity of the data for each object entered into the spreadsheet using the same validation rules as in Architect. If the system encounters a validation error the upload process fails and no changes are made to the target draft. This is called a rollback. Errors in the upload process cause rollbacks. These errors are sometimes referred to as “rollback conditions”. When a rollback condition is encountered, the system aborts the upload process and no changes are made to the target database. The system provides a detailed listing of all the errors found in the spreadsheet so they can be resolved prior to attempting another upload. Rollback conditions are often produced by “essential references to objects that cannot be created by their identities alone.” This concept links back to the External Objects concept discussed earlier in this manual. For example, if a field in the spreadsheet references a coding dictionary (which is an external object), but that coding dictionary does not exist on the target database. Simply naming the coding dictionary in the spreadsheet does not actually create that dictionary in the target database. That coding dictionary needs to be uploaded on the back end of the system in order for that field to be viable. The field cannot work unless that coding dictionary exists on the target database. To eliminate this rollback condition, either the coding dictionary must be uploaded on the backend of the target database prior to the upload or the reference to the coding dictionary must be removed from the spreadsheet. The following are some common conditions generate errors, causing a transaction rollback: 





Dangling draft object references, or said another way, references to non-existent draft objects. For example, referencing a coding dictionary that doesn’t exist in the target draft. Object definitions that are incomplete, invalid, or inconsistent. For example, if you have a dropdown list control type selected for a field, but you have not applied a dictionary to the field. Or, you define data dictionary entry user strings but leave the coded value blank Database and application errors, which are any exceptions caught during the processing of an object.

Only a draft in which all objects are successfully validated will be uploaded to the target database. If a rollback occurs, the upload progress page displays all errors -- in collapsible format -- encountered during the upload, separated by object. To resolve the errors, the data in the spreadsheet must be modified and then uploaded again. Uploading a spreadsheet can be a resource-intensive process. In order to minimize the number of uploads required, the system will process all objects in a spreadsheet during each upload, and will display all errors for the entire draft. Users can then correct all errors before attempting another upload.

Note: Any data that is unacceptable in Architect is unacceptable in the Architect

Loader.



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To View Errors Encountered During the Upload Process: 1. Upload an Architect Draft Spreadsheet using the steps outlined in the previous sections of this manual. Any objects that encountered errors during upload are displayed with a non-conformant icon to the left, and an error detail arrow to the right. A message at the top of the screen indicates that the transaction was rolled back (no changes made to the target draft).

2. To view the error(s) for a specific object, click the Error Detail Arrow to the right of the object name. Details for each error are displayed. To hide the error(s) click the Error Detail Arrow again.

3. Resolve all errors by editing the specified objects in the spreadsheet. 4. Repeat the upload process once all errors have been resolved.

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Partial Uploads This chapter will cover the following topics: 

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Partial Uploads



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Partial Uploads The Architect Draft Spreadsheet can be uploaded containing all objects or can be uploaded containing specific objects of the user’s choosing. This is useful when the desired result is to copy, for example, specific forms, fields, and dictionaries from one draft to another, but nothing else. A partial upload is conducted by removing any worksheets that are not required for the upload. For example, if only custom functions will be uploaded, then all worksheets other than the Custom Functions worksheet and the CRF Draft worksheet can be removed from the spreadsheet. The CRF Draft worksheet is required for all uploads. Partial uploads can only be conducted during a draft merge. If a new project, Global Library, or Draft will be created during the upload process, or if a draft will be overwritten, all worksheets are required. Worksheets may be left empty if needed, as long as they exist in the spreadsheet.

To Conduct a Partial Upload: 1. Download an Architect Draft Spreadsheet for the desired draft, using the steps described in previous sections of this manual. 2. Using Excel tools, do one of the following: 

Delete all object worksheets such that only the worksheets to be uploaded remain. Note that the CRF Draft object worksheet is REQUIRED for all uploads.



Create a new Excel file and copy the CRF Draft object worksheet and all other desired worksheets into this new file. Note that when saving this file it must be saved with an .XML extension. The filename may include spaces, hyphens or underscores.

3. Upload the Architect Draft Spreadsheet using the steps described in previous sections of this manual.

Note: When copying objects from one spreadsheet to another, links may be formed

between the two spreadsheets. Spreadsheets containing links cannot be uploaded into a Rave database; all links must be severed prior to uploading a spreadsheet. To sever links, use Excel menu path: Edit | Links…

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After a Successful Upload… This chapter will cover the following topics:

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

What Happens After a Draft Spreadsheet is Uploaded?



The Upload Trail



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What Happens after a Draft Spreadsheet is Uploaded? Once a draft spreadsheet is successfully uploaded into the target database, the draft contents can be maintained in Architect, just like any other project or Global Library Volume draft. 

If a new project or Global Library Volume was created during the upload, that new project or Global Library Volume can be accessed in the Architect module.



If a new draft was created in an existing project or Global Library Volume during the upload, that draft can be accessed within the existing project or Global Library Volume in the Architect module.



If a draft was merged or overwritten during the upload, that draft can be accessed within the existing project or Global Library Volume in the Architect module.

Within the uploaded draft, an upload history is displayed. Refer to the next section of the manual for details.

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The Upload Trail The Upload Trail on the draft page of any uploaded draft provides a history of uploads that have taken place for that draft.

The Upload Trail consists of the following information: •

•

•

ID: a numeric identifier for the upload. Each entry in the upload trail will get an ID number, starting with the number 1, in increasing numeric order. User: the first and last name of the person who uploaded the draft spreadsheet. Action: the action will display one of the following: Create, Merge, or Overwrite, depending on the type of upload performed. 1. Create: a new draft was created as a result of a spreadsheet upload. Create will always appear in the upload trail.



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Architect Loader Training Manual 2. Merge: a spreadsheet was uploaded to an existing draft, and the Delete Existing column on the CRF Draft worksheet was set to False. The existing draft was updated to include the information from the existing spreadsheet. A merge action will only appear in the upload trail if the “Save Upload History for Roll-back” box was checked prior to the upload. 3. Overwrite: a spreadsheet was uploaded to an existing draft, and the Delete Existing column on the CRF Draft worksheet was set to True. Any existing information in the draft was removed and replaced with the uploaded draft. An overwrite will appear box in the upload trailprior if the “Save Uploadaction History foronly Roll-back” was checked to the upload.

•

•

•

•

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Date: the date and time the spreadsheet was uploaded. Restore: when clicked, the draft is returned to the state it was in immediately prior to the upload. This link is only available if the “Save Upload History for Roll-back” box was checked prior to the upload. The Restore icon is only displayed for users with Stage 1 and Stage 2 project permissions, or Update Global Library Volume permission.

Backup: when the Backup icon is clicked, the system will allow the user to download a spreadsheet of the draft as it existed prior to the upload. This link is only available if the “Save Upload History for Roll-back” box was checked prior to the upload. The spreadsheet can then be uploaded into the target database to return the draft to its previous state. The Backup icon is only displayed for users with Download permission. File: when the File icon is clicked, the system will allow the user to download a spreadsheet of the draft that was uploaded at the time of the listed action. The File icon is only displayed for users with Download permission.



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Downloading a Draft Spreadsheet Template This chapter will cover the following topics: 

88

Downloading a Draft Spreadsheet Template



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Downloading a Draft Spreadsheet Template A blank template of a draft spreadsheet can be downloaded from the main page in the Architect module. The template contains all the object worksheets, include column headings and sort capability. The template can be used to develop eCRFs and data validations offline, and can then be uploaded into the Rave system. Although data validations can be defined directly on the spreadsheet, it is recommended that they be defined within the Rave system for efficiency. The spreadsheet template also contains a cover sheet worksheet, which contains instructions for filling out the spreadsheet. Additional instructions are available on each worksheet, and can be accessed by scrolling to the right on any given worksheet. The draft spreadsheet is downloaded in a compressed (zipped) Excel file, with an .xls extension. The .xls spreadsheet must be saved as an .xml file before it can be uploaded into a target Rave database.

Note: The template must be saved as an .xml file in order to be uploaded into Rave.

To Download a Draft Spreadsheet Template: 1. Navigate to the Architect module within Rave by clicking on the Architect link on the sidebar of the Rave homepage.

2. In the sidebar of the Architect main page, click Get Draft Template.

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3. In the pop-up window displayed, click Save to save the zip file containing the template.

4. The filename defaults to RaveDraftTemplate.zip. This can be overridden if desired. Navigate to the location to which the file should be stored and click Save to download the zip file.

5. When the download is complete, navigate to the location where the file is saved, and double-click the .zip file to launch. 6. The RaveDraftTemplate.xls spreadsheet file is displayed in the zip window. Double-click the filename to launch the Excel spreadsheet.



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7. When the spreadsheet is opened, it must be then saved as a .xml file in order to be uploaded into the Rave system. To save the file as a .xml file, use Excel menu path File | Save As…

8. Navigate to the location to which the file should be saved. Enter a file name and select a Save as Type: value of .xml, and click Save.

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Appendix A: Architect Security Permissions The following permissions are required for downloading/uploading Architect Projects. Refer to the Architect Security Training Manual for additional information.

Architect Security Project Permissions The following permissions are required for downloading/uploading Architect Projects: 

To download a draft of a project, Download is required, along with Read access to the project being downloaded. .



To upload/overwrite an existing draft or restore a draft for a project, Upload is required, along with Update, Stage 1, and Stage 2 permissions for the specific project.



To merge an existing draft or create a new draft for a project, Upload is required, along with Update, Stage 1 (if uploading Stage 1 objects), and Stage 2 (if uploading Stage 2 objects) for the specific project.



To upload and create a new project Upload is required, along with Create. The user does not need Update, Stage 1, and Stage 2, even if the draft contains objects in those categories.

If the user does not have Download or Upload permission, the Download or Upload link will not be displayed. If the user tries to upload a worksheet without the appropriate project-specific permissions, the upload will be rejected and an error message displayed.

Architect Security Global Library Permissions The following permissions are required for downloading/uploading Architect Global Library Volumes. Refer to the Architect Security Training Manual for additional information. 

To download a draft of a Global Library Volume, Download is required, along with Read access to the project being downloaded.



To upload and overwrite an existing draft or restore a draft for a Global Library Volume, Upload is required, along with Update permissions for the specific project.



To upload and merge an existing draft or upload and create a new draft for a Global Library Volume, Upload is required, along with Update permissions for the specific project.



To upload and create a new Global Library Volume Upload is required, along with Create. The user does not need Update.

If the user does not have Download or Upload permission, the Download or Upload link will not be displayed. If the user tries to upload a worksheet without the appropriate Global Library Volume-specific permissions, the upload will be rejected and an error message displayed.

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Appendix B: Usage Recommendations As we have learned, the Architect Loader is a powerful tool. Below are recommendations for use, along with Best Practices.

When Do I use Architect Loader? 

When creating a new project in Rave



When copying a previous project to modify and upload in Rave

What Should I Use it For? 

Creating new eCRF drafts based on drafts from local and remote Rave databases



Downloading eCRF draft data for offline editing



Copying sections of a draft from one project to another



Uploading spreadsheets into a different project within the same database or into another database



Updating and saving the existing draft



Downloading a draft spreadsheet template

When Might Editing in Rave be more Efficient? 

When configuring Data Validations, it will be more efficient to edit directly in Rave.



Checks can be uploaded/downloaded into projects and Global Library Volumes in local and remote databases, but all checks should be modified live in Rave to reduce entry errors.

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Appendix C: Synchronizing Object Identifiers (OIDs) On the CRF Draft worksheet, there are four settings that allow users to synchronize OIDs from one draft or version to another. These settings are: •

•

•

•

Sync OID Project: user-defined project or Global Library Volume (GLV) name. The Project or GLV name that is entered will be used as the synchronization srcin. Sync OID Draft: user-defined draft identifier. The Draft name that is entered will be used as the synchronization srcin. Sync OID Project Type: Indicates whether the synchronization srcin is an Architect project or Global Library Volume. Sync OID Origin Is Version: user-defined version identifier. The Version name that is entered will be used as the synchronization srcin.

These settings are combined to synchronize OIDs that may be different between drafts or versions in the same database. Refer to the following sections in this appendix for additional information on synching OIDs.

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Why Would You Synchronize OIDs? When a draft or version is downloaded or uploaded into Rave, certain objects are identified and created/updated based on their OIDs, and other objects are identified and created/updated based on their names. An example of an OID-identified object is a form. Let’s say you download a spreadsheet containing a form with the name “Demography” and an OID of “DEMOG”. If you change the form name to “Demographics” and upload the spreadsheet into a new draft or version, you will end up with a form named “Demographics” with an OID of “DEMOG”. Alternatively, let’s look at an example of a name-identified object. Let’s take a dictionary named “Race”. Although it is not displayed in the Rave UI, the Race dictionary has an OID that was defined by the system when the dictionary was initially created. Let’s say that the OID is “RACE”. If an end-user updates the name of the dictionary to “Ethnicity”, the system-defined OID is not changed; it remains the same: “RACE”. If you download a spreadsheet from the draft or version containing this dictionary, the dictionary will be listed as “Ethnicity”. When you upload the spreadsheet into a new draft or version, the system will create a new dictionary called “Ethnicity”, and will automatically assign an OID of “ETHNICITY”. In this case, you end up with a draft or version that contains objects that are different from how they initially appeared. The draft or version we downloaded from contains a dictionary named “Ethnicity” with an OID of “RACE”. The draft or version we uploaded contains a dictionary named “Ethnicity” with an OID of “ETHNICITY”. There are certain scenarios in which this might cause a problem – specifically, if you need to migrate subjects from a version created in the first draft to a version created in the second draft. The objects between those two drafts are now defined differently, so this can prevent you from properly mapping objects in your migration plan.



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Understanding System-Defined OIDs There are several objects within Architect that do not allow users to define their OIDs; the system will automatically create their OIDs. For example, when creating a Form you must define a Form OID, however when you create a Data Dictionary, the system generates the OID for you based on the Dictionary name that you supply. The following objects have OIDs defined automatically by the system: 

Data Dictionaries



Unit Dictionaries

 

Edit Checks Derivations

These system-generated OIDs are referred to as “Standard OIDs” because they typically follow a specific convention based on an object’s name. For example, a system-generated OID for a dictionary named “Race” might be “RACE”. If any spaces or special characters were used in the dictionary name, they would be replaced with underscores, i.e. a dictionary named “Yes&No” might have a systemgenerated OID of “YES_NO”. Occasionally, situations may arise where these OID/Name combinations become non-standard – in other words – when the OIDs and names do not match. These non-standard OIDs can occur in several ways, including: 

An object name changes after a standard OID is assigned, i.e., a dictionary called “Race” is created, and a standard OID of “RACE” is assigned. An end-user renames the dictionary “Ethnicity”. The OID remains unchanged, resulting in a non-standard OID/name combination.



An object’s OID is changed used the Global Library OID-changing utility. For example, a “Race” dictionary has a standard OID “RACE”, and using the Global Library an end-user changes the OID to “ETHNICITY”. The name remains unchanged, resulting in a nonstandard OID/name combination.



An object’s name is translated/localized to another language.

Non-standard OID/name combinations can produce unintended results when downloading/uploading project using the Architect Loader utility.

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Specifying to Sync with a Version Draft names are unique in a project, as well as version names. You cannot have two drafts, or two versions, with the same name; however you can have a draft name and a version name that are the identical. For example, in the Fixitol project there is a draft named “1.0” and a version that is also named “1.0”.

This is acceptable in Architect but when you want to synchronize OIDs the system will not know if you want to synchronize with the draft or the version. The Sync OID Origin Is Version setting allows you to define whether to sync to a draft or a version. If Sync OID Origin Is Version is TRUE, the system will synchronize with a version. If Sync OID Is Version is FALSE, the system synchronize with a draft. The default setting for the Sync OID Is Version column is FALSE. If the Sync OID Origin Is Version setting is TRUE and the Sync OID Draft name does not match a version name, in the same project, a rollback will occur when you upload the spreadsheet.



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Synchronizing OIDs: An Example Let’s explore a bit more deeply a scenario where you would need to sync OIDs from one draft to another. When performing a migration, the system looks at the OIDs of the data being migrated and expects the OIDs of equivalent objects to be identical. If the OIDs are different, the mappings will not be correct. The system will default the fields that need to be migrated to ‘Do Not Migrate’. If the OIDs are identical, then the data will map correctly. Before a migration can be performed, it is necessary to make sure the OIDs of corresponding objects are identical to avoid any issues with the migration.

Note: For more information on migrating data and mappings, refer to the

Amendment Manager Training Manual.

In this example, we are looking at the Fixaloid project which contains a draft, Draft 1.0. Draft 1.0 contains forms, fields, dictionaries and many other objects. In Draft 1.0 we create an edit check “Dem 001”. The system assigns an OID of “DEM001” when the object is initially saved. We realize that the check should have been named “Dem 002”, so we rename the check. The OID remains “DEM001”. Next, we publish a version, “Version A”, and add some subjects. Now let’s say a protocol change results in a change to our edit check, some forms, fields, etc. We’ll need to change the check logic, and also make updates to the other objects in our draft based on this protocol change. We download our version into an Architect Loader spreadsheet and make the changes offline. We will upload the spreadsheet into a new draft, Draft 2.0. When we upload the spreadsheet, we end up with an edit check “Dem 002” that has an OID of “DEM002” – this is because edit checks are created based on name rather than OID. The edit check in this draft (Draft 2.0) is different than the one we started out with in Draft 1.0. In Draft 1.0, our edit check was named “Dem 001” and had an OID of “DEM001”. The edit checks are the same in all other respects. We publish a version of Draft 2.0, “Version B”. In order to have the subjects from Version A reflect the changes that are now available in Version B, we need to do a migration. Unfortunately, the edit check “Dem 002” will not map correctly – the system maps objects based on OID. That means that the system will think that our edit checks in Version A and Version B are different, simply because they have different OIDs (“DEM001” and “DEM002” respectively.) This will prevent us from mapping the edit checks and effectively migrating our subjects from Version A to Version B. Now, let’s say that prior to doing our upload we used the Sync OIDs feature. The Sync OIDs feature will enable us to select a project/GL draft that contains the OIDs we want the system to assign to our objects when the new draft is created during the upload. The system will look at the object names in the draft we are uploading, and if an object name in the spreadsheet matches an object name in the Sync OID draft, the system will assign the OID used in the Sync OID draft to the object being created spreadsheet is uploaded. example, theedit spreadsheet contains the edit when check the “Dem 002” and the Sync OID For draft containsifthe check “Dem 002”, when the system creates the “Dem 002” edit check in our new draft during the upload process, whatever OID is assigned to “Dem 002” in the Sync OID draft will be assigned to the “Dem 002” edit check in the newly created draft.

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In the spreadsheet, it is necessary to define the project and draft that contains the OIDs to which we want to sync. For this example, ‘Fixaloid’ would be entered as the SyncOIDProject setting; ‘Draft 1.0’ would be entered as the SyncOIDDraft setting; and ‘Project’ would be entered as the SyncOIDProjectType setting. The system will behave differently depending on the type of uploading you are performing. 

If the upload will perform an overwrite or create a new draft, the uploaded (target) draft’s OIDs will be the same OIDs as in the Sync OID (source) draft.

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If the upload results in duplicate OIDs, synchronizing the OIDs could create a conflict. In this case, Architect Loader will revert to its normal OID-generating process for the conflicting objects, which is a transaction rollback.

For this example, let’s say that we performed an overwrite. The Sync OID draft will be Draft 1.0 and the target (upload) draft is Draft 2.0.

As a result of the upload, the “Dem 002” edit check will have an OID of “DEM001”. Since the OIDs will match, the subjects from Version A can be migrated to Version B without any issues related to unsynchronized OIDs.



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