563 Lab Loader 04302008 FINAL

Medidata Rave® 5.6.3

Lab Loader Training Manual Version 1.0

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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PROPRIETARY – LIMITED DISTRIBUTION

Lab Loader Training Manual

Document Version 1.0

Medidata Rave 5.6


Revision History Version 1.0

Date April 2008

Changed by Carrie Barent

Description of Changes Original Release

Instructional Designer

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. 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.



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Table of Contents Welcome .................................................................................. 7 Using This Manual .........................................................................................7

Introduction to Lab Loader....................................................... 9 Downloading Lab Settings ...................................................... 11 Lab Loader Overview...................................................................................13 Accessing Lab Loader ..................................................................................14 Downloading Lab Settings...........................................................................15

The Lab Loader Spreadsheet .................................................. 19

Lab Loader Spreadsheet Overview ..............................................................21 Lab Objects in the Spreadsheet...................................................................22 Common Controls in the Spreadsheet .........................................................24 Worksheet Details in the Spreadsheet ........................................................26 Cover Worksheet ......................................................................................26 Analytes Worksheet...................................................................................26 Central Lab Assignments ............................................................................27 Clinical Significance Codes Worksheet ..........................................................29 Global Data Dictionaries Worksheet .............................................................30 Global Data Dictionary Entries Worksheet .....................................................30 Labs Worksheet ........................................................................................32 Analyte Ranges Worksheet .........................................................................34 Global Unit Dictionaries Worksheet ..............................................................38 Global Unit Dictionary Entries......................................................................38 Global Variables........................................................................................41 Lab Units Worksheet..................................................................................42 Lab Unit Dictionaries..................................................................................43 Lab Unit Dictionary Entries .........................................................................43 Range Types Worksheet.............................................................................45 Range Type Variables Worksheet.................................................................45 Standard Groups Worksheet .......................................................................48 Standard Group Entries Worksheet ..............................................................48 Unit Conversions Worksheet .......................................................................50 Example: Adding a New Analyte and a Lab Unit Dictionary .........................52 Editing or Deleting Data (Protected Worksheets)........................................54

Uploading a Draft ................................................................... 55 The Upload Process .....................................................................................56 Uploading a Spreadsheet.............................................................................57 Understanding the Upload Process Page .....................................................59 Errors in the Upload Process .......................................................................62

Downloading a Spreadsheet Temp late ................................... 65 Downloading a Spreadsheet Template ........................................................67 Document Version 1.0


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Welcome This manual is designed to be a useful and detailed reference for the Lab Loader 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. 

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Information in these gray boxes is to be noted or critical. Be sure to pay special attention to the instructions or information here. Note:

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 Lab Loader The Lab Loader in Rave enables a user to take all of the lab settings from the Lab Administration module and extract into an Excel spreadsheet. The data in the spreadsheet can be used for offline documentation and maintenance. The downloaded and maintained Excel file can be uploaded back into the same database or a different database. Once uploaded, the lab settings can be maintained in the Lab Administration module.



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Downloading Lab Settings This chapter will cover the following topics: 

Lab Loader Overview



Accessing Lab Loader



Downloading Lab Settings



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Lab Loader Overview The Lab Loader in Rave enables a user to take all of the lab settings from the Lab Administration module and extract into an Excel spreadsheet, where offline documentation and maintenance of the lab settings can be conducted. The downloaded and maintained Excel file can be uploaded back into the same database or a different database. Once uploaded, the lab settings can be maintained in the Lab Administration module. Lab Loader allows users to: 

Download labExcel settings from the Lab Administration module for offline editing in an spreadsheet.

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Copy large chunks of lab settings from one database to another.

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Upload lab settings to the Lab Administration module within the same database, or into another database.

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Update and save the existing lab settings.

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Download a blank template.

The lab settings that are downloaded are stored in an XML spreadsheet format that is compatible with Microsoft Excel 2002+. The benefits of Lab Loader include: 

Reduce amount of time of manual activity needed to create and maintain lab settings.

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Ability to upload lab settings from one database to either the same database or a separate database.

In order to use Lab Loader you must be familiar with the Lab Administration module. Please attend the Rave Lab Administration Training and refer to the “Lab Administration” Training Manual for more information about the Lab Administration module. Note:



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Accessing Lab Loader A user can access Lab Loader if the “Use Lab Loader” setting is configured in the Configuration module.

To Access the Lab Loader: 1. Click on the Lab Administration link from the list of Installed Modules on the Rave Home Page.

2. Click on the Lab Loader link from the Lab Administration page.

3. The Lab Loader page is displayed.

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Downloading Lab Settings Lab Loader allows you to download all lab settings or one specific lab setting. For example, you can download Analytes only without downloading Global Labs, Lab Units or any other lab settings. Selecting all lab settings or a specific lab setting to download will be done using a “Select Sheet” dropdown list. The lab setting(s) will be downloaded by using a “Download” button. The data is extracted into an Excel spreadsheet for offline documentation and maintenance. The spreadsheet is an XML file and will be downloaded as a zip file.

To Download Lab Settings: 1. Access the Lab Loader by clicking the Lab Loader link in the Lab Administration module. 2. In the Download section, select a lab setting to download. 

Select All to download details for all lab settings.

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Select a specific lab setting to download details for only that lab setting.

3. Click the Download button.

The Download button will be disabled if there is no selection in the Select Sheet dropdown list. Note:



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4. A pop-up is displayed, indicating that a compressed (zip) file must be downloaded to access the spreadsheet.

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Click Save, and select the location to which the compressed file should be downloaded.

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Browse to the desired location and click Save to save the compressed file. The filename defaults to <”DownloadType”_YYYY_MM_DD.zip>.



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5. 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.

6. When the spreadsheet is launched, the contents can be edited as needed. Refer to the next sections of the manuals for additional information.

The worksheet content will be downloaded in the locale that is specified in the My Profile section of Rave. Note:



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The Lab Loader Spreadsheet This section will cover the following topics: 

Lab Loader Spreadsheet Overview

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Lab Objects in the Spreadsheet

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Common Controls in the Spreadsheet

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Worksheet Details in the Spreadsheet

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Example: Adding a New Analyte and a Lab Unit Dictionary

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Editing or Deleting Data (Protected Worksheets)



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Lab Loader Spreadsheet Overview Within the spreadsheet, each object, resides on its own worksheet. An object is a lab setting, i.e. Analytes, Lab Units, etc. For each object that resides on the spreadsheet, each property is listed. For example, a Global Variable object will display the OID, data format, and which Global Data Dictionary or Global Unit Dictionary the Global Variable is associated to. Each property that is defined in Lab Administration is represented in the spreadsheet. For example, in Rave when defining an Analyte you must provide a name, its active status, a lab unit dictionary, and whether it can accept leading symbols. If you are creating or editing an Analyte in the Lab Loader spreadsheet, the same properties are required. You can edit the object definitions as needed, add new definitions or delete existing definitions. The Lab Loader spreadsheet contains a Cover worksheet that can be updated as needed. The Cover worksheet is used to specify the client name, project number and project team and revision history. Although updating the Cover worksheet is not required in order to use the Lab Loader, it is recommended for tracking purposes.

The information specified in the Cover worksheet will not alter how the spreadsheet is uploaded into Rave. The contents of the Cover worksheet are ignored by the system and will not be uploaded to the database. Completing the Cover worksheet is optional. Note:



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Lab Objects in the Spreadsheet Within the Lab Loader spreadsheet, objects are represented in text format on objectspecific worksheets. For example, the Clinical Significance Codes worksheet will display each significance code, along with its properties as defined in the Lab Administration module. Each property is stored in its own worksheet cell. To define a new property, or edit an existing one, simply click in the cell and start typing. For some cells, you can also select from a list of pre-defined values available in a dropdown list within the cell. The lab object-types listed below are represented on their worksheets within the Lab Loader spreadsheet. In several cases, data from one worksheet is available for selection on another. For example, the Global Unit Dictionaries Entries worksheet depends on the unit dictionaries entered on the Global Unit Dictionaries worksheet. Based on these dependencies, below is the recommended order in which the worksheets should be filled out. 1. Global Unit Dictionaries 2. Global Unit Dictionary Entries 3. Global Data Dictionaries 4. Global Data Dictionary Entries 5. Global Variables 6. Range Types 7. Range Type Variables 8. Lab Units 9. Lab Unit Dictionaries 10. Lab Unit Dictionary Entries 11. Analytes 12. Unit Conversions 13. Standard Groups 14. Standard Group Entries 15. Central Lab Assignments 16. Labs 17. Analyte Ranges 18. Clinical Significance Codes

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The order above also follows the sequence that defines and maintains a Lab range management system in the Lab Administration module. Each object listed above is found on its own worksheet in the Lab Loader spreadsheet. For brief definitions of each object refer to the tables on the following pages. For detailed definitions, refer to the “Lab Administration” Training Manual.



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

Each object-type resides on its own worksheet within the same workbook (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.

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Each available property for an object type is displayed as the column header in the worksheet, as seen below.

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In parent-child relationships, as seen across Global Data Dictionaries and their entries, the child object references the parent object Name or OID on the child worksheet. For example, the Global Data Dictionary “Gender” will be an entry on the Global Data Dictionary worksheet (parent).

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

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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.

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Each column heading on a worksheet has a filter that enables a user to filter the list by selecting the desired value in the dropdown 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 are available as dropdown lists on the worksheet cell. For example, defining whether an Analyte is active or not is selected from a list of pre-defined actions, True and False. This prevents you from entering an invalid value.

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When entering values into the spreadsheet, all rules that apply in the Lab Administration module should be adhered to. For example, when defining a Global Variable in the spreadsheet, the Variable OID must be unique among the other Global Variable OIDs. The spreadsheet will allow you to enter values that do not adhere to the standards; however when the file is uploaded into the target database, the invalid value will be returned as an error and the entire spreadsheet will not be uploaded.



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Worksheet Details in the Spreadsheet The following sections list the contents of each worksheet in the Lab Loader spreadsheet. For complete definitions of each property and how it is built in Lab Administration, refer to the Lab Administration Training Manual. The worksheets are discussed in the order in which they appear in the Lab Loader spreadsheet template.

Cover Worksheet The Cover Page worksheet is the only optional worksheet in the spreadsheet. Its contents are used for informational purposes only. The Cover Page worksheet displays all project information, i.e. Sponsor name, URL, Project Managers, etc. An area to record the revision history is available and can be used to track the changes made within the spreadsheet. This area displays the version number of the template, effective date, and name of the user who made the change and what changes were made.

Analytes Worksheet The Analytes worksheet corresponds to the Analytes section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Analytes worksheet.

Analytes Worksheet Property Name

Definition User-defined name for each Analyte. This property is required.

Lab Unit Dictionary

Selected from a dropdown list, whose contents are pulled from the Lab Unit Dictionaries worksheet in the spreadsheet. A Lab Unit Dictionary must exist on the Lab Unit Dictionary worksheet in order for its name to exist in the dropdown list on the Analytes worksheet. This property is required.

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Analytes Worksheet Property

Definition

Allow Leading Signs

If TRUE, the end-user is able to enter a leading Greater Than (>) or Less Than (<) symbol when entering values into fields associated with the specified Analyte. If FALSE, the end-user cannot enter leading symbols into fields associated with the specified Analyte. This property is selected via a dropdown list and is required.

Active

If TRUE, the Analyte is set as active. If FALSE, the Analyte is set to inactive. This property is selected via a dropdown list and is required.

The Analytes worksheet is sorted alphabetically by Lab Unit Dictionary name first, then by Analyte name. Note:

Central Lab Assignments The Central Lab Assignments worksheet corresponds to the Central Labs section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Central Lab Assignments worksheet.

Central Lab Assignments Worksheet Property Lab

Definition User-defined name for the Central Lab. The worksheet is sorted in alphabetical order by Lab. The Lab name must match the Lab name in the Labs worksheet. This property is required.



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Central Lab Assignments Worksheet Property Study

Definition User-defined name of the study to which the central lab will be assigned to. This property is required.

Environment

User-defined name of the environment to which the central lab will be assigned to. This property is required.

Site Number

User-defined number that is assigned to the Site to which the central lab will be assigned to. This property is required.

Active

If TRUE, the Central Lab is set as active. If FALSE, the Central Lab is set to inactive. Selected via a dropdown list. This property is required.

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Clinical Significance Codes Worksheet The Clinical Significance Codes worksheet corresponds to the Clinical Significance Codes section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Clinical Significance Codes worksheet.

Clinical Significance Codes Worksheet Property Code

Definition User-defined unique code for the Clinical Significance Code. The worksheet is sorted in alphabetical order by Code. This property is required.

Description

User-defined text that indicates whether or not a lab value entered on a field is clinically significant. This property is required.

Comments Required

If TRUE, comments are required to explain the significance. If FALSE, comments are not required. This property is selected via a dropdown list, and is required.

Active

If TRUE, the code is set as active. If FALSE, the code is set to inactive. This property is selected via a dropdown list and is required.



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Global Data Dictionaries Worksheet The Global Data Dictionaries worksheet corresponds to the Global Data Dictionaries section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Global Data Dictionaries worksheet.

Global Data Dictionaries Worksheet Property Name

Definition User-defined name for the Global Data Dictionary. The worksheet is sorted in alphabetical order by Name. This property is required.

Active

If TRUE, the Global Data Dictionary is set as active. If FALSE, the Global Data Dictionary is set to inactive. This property is selected via a dropdown list and is required.

Global Data Dictionary Entries Worksheet The Global Data Dictionary Entries worksheet corresponds to the Global Data Dictionary Entries section in Lab Administration, as seen in the following screenshot.

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The following properties are displayed on the Global Data Dictionary Entries worksheet.

Global Data Dictionary Entries Worksheet Property Global Data Dictionary

Definition User-defined name for the Global Data Dictionary. The worksheet is sorted in alphabetical order by Global Data Dictionary. This property is selected via a dropdown list whose contents are pulled from the Global Data Dictionaries worksheet in the spreadsheet. A Global Data Dictionary must exist on the Global Data Dictionary worksheet in order for its name to exist in the dropdown list on the Global Data Dictionary entries worksheet. This property is required.

Ordinal

The position of the Global Data Dictionary entry within the list of entries. This property is required.

Coded Data

User-defined database value for the entry. This property is required.

User Data String

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

Active

If TRUE, the Global Data Dictionary Entry is set as active. If FALSE, the Global Data Dictionary Entry is set to inactive. Selected via a dropdown list. This property is required.



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Labs Worksheet The Labs worksheet consists of four different types of labs. Lab types that can be created using the Labs worksheet are: 

Local Labs

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Central Labs

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Alert Labs

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Reference Labs

The following properties are displayed on the Labs worksheet.

Labs Worksheet Property Name

Definition User-defined name for the lab. This property is required.

Type

Specifies the type of lab that is being created. This property is selected via a dropdown list, and is required. The dropdown consists of the four lab types.

Study

User-defined name of the study to which the local lab will be assigned to. This property is required for Local Labs only.

Environment

User-defined name of the environment to which the local lab will be assigned to. This property is required for Local Labs only.

Site Number

User-defined number that is assigned to the Site where the Local Lab will be assigned to. This property is required for Local Labs only.

Range Type

User-defined name for the Range Type. This property is selected via a dropdown list and is required. The contents of the dropdown list are pulled from the Range Types worksheet in the spreadsheet. A Range Type must exist on the Range Types worksheet in order for its name to exist in the dropdown list on the Labs worksheet.

Description

User-defined text that describes the lab. This property is required.

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Labs Worksheet Property Ranges Approved

Definition If TRUE, the lab ranges for the specific lab have been approved by a Lab Administrator. If FALSE, the lab ranges have not been approved. This property is required.

Active

If TRUE, the Global Data Dictionary Entry is set as active. If FALSE, the Global Data Dictionary Entry is set to inactive. Selected via a dropdown list. This property is required.

Note:

The Labs worksheet is sorted by Lab Type first, then by Study, then by

Name.



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Analyte Ranges Worksheet The Analyte Ranges worksheet contains the ranges that are created for each Analyte within a lab. The properties can be found in the Central Lab section and the Global Labs section of Lab Administration. The following properties are displayed on the Analyte Ranges worksheet.

Analyte Ranges Worksheet Property Lab

Definition User-defined name for the Lab. This property is selected via a dropdown list and is required. The dropdown’s contents are pulled from the Labs worksheet in the spreadsheet. A Lab must exist on the Labs worksheet in order for its name to exist in the dropdown list on the Analyte Ranges worksheet. The worksheet is sorted in alphabetical order by Lab.

Lab Type

Specifies the type of lab that is being created. This property is selected via a dropdown list, and is required. The dropdown consists of the four lab types. If you manually enter a value rather than selecting one off of the dropdown list, an Excel error message will appear stating the value that was entered is not valid.

Study

User-defined name of the study to which the local lab will be assigned. This property is required for Local Labs only.

Environment

User-defined name of the environment to which the local lab will be assigned. This property is required for Local Labs only.

Site Number

User-defined number that is assigned to the Site where the Local Lab will be assigned to. This property is required for Local Labs only.

Analyte

User-defined name for each Analyte. This property is selected via a dropdown list and is required. The dropdown’s contents are pulled from the Analytes worksheet in the spreadsheet. An Analyte must exist on the Analytes worksheet in order for its name to exist in the dropdown list on the Analyte Ranges worksheet.

From Date / To Date

User-defined dates for which the range is valid. The To Date cannot be before the From Date. The format of the dates is displayed in the date format as specified in the Configuration module.

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Analyte Ranges Worksheet Property Low Value / High Value

Definition The minimum and maximum numeric values that fall within the range. The High Value must be greater than the Low Value.

Lab Unit

The standard unit for the range. The Lab Unit must match the Name in the Lab Units worksheet. This property is required.

Global Data Dictionary

The data dictionary that is assigned to the range.

Comments

User-defined text displaying comments for the range.

Active

If TRUE, the Analyte Range is set as active.

The Global Data Dictionary must match the Name in the Global Data Dictionaries worksheet.

If FALSE, the Analyte Range is set to inactive. This property is selected via a dropdown list and is required.

The Analyte Ranges worksheet creates columns dynamically, based on the Range Type. For example, let’s say you have defined a Standard Range Type in Rave that includes Ranges the “Age” and “Sex”The variables. variable will have its own column in the Analyte worksheet. column Each headers correspond to what is built within Rave. Once the lab settings have been downloaded, the worksheet will create the dynamic columns. Depending on the variable, more than one column may be created in the Analyte Ranges worksheet for that variable.

Although you are able to manually define these dynamic columns in a blank spreadsheet (following the prescribed naming convention), it is recommended to build these variables in the Lab Administration module of Rave. Note:

Below are two examples that explain how the worksheet creates additional columns. The first example shows how the columns are generated for Global Variables that use a Global Data Dictionary. The second example shows how the columns are generated for Global Variables that use a Global Unit Dictionary. Example 1: Global Variable Using a Global Data Dictionary If the Global Variable is associated with a Global Data Dictionary, then one column for the Global Variable will be added. Here we see the Global Variable of Sex. The Sex Global Variable is associated with the Sex Global Data Dictionary.



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When the lab settings are downloaded, an extra column is added to the right-most column in the worksheet. This column is for the Sex Global Variable.

The naming convention for the new column is __. Each property type is separated by an underscore. In the screenshot above, this convention translates to: Standard_Sex_Sex.Example 2: Global Variable Using a Global Unit Dictionary If the Global Variable is associated with a Global Unit Dictionary, four columns will be created for the Global Variable. The screenshot below shows how the Age variable is associated to a Global Unit Dictionary, Year.

When setting up Lab Ranges, Analytes are associated with the Global Variable, Age. Below you can see two Analytes, Hematocrit and WBC, that are associated with the Age Global Variable. For each range, we must specify the Low Range and the unit of measure (“From Age” and “Year”), the High Range and the unit of measure (“To Age” and “Year”). This information is represented in the Lab Loader spreadsheet as well.

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When these lab ranges are downloaded using Lab Loader, four additional columns will be added to the right-most column in the worksheet. Two of the columns will define the low and high values that make up the valid age range. The other two columns indicate the unit of measure for the low and high values. The unit of measure is defined in each Analyte’s Global Unit Dictionary.

The naming convention for the two low/high columns is: __ Each property type is separated by an underscore. In our example, this convention translates to: Standard_Age_From_Age Standard_Age_To_Age

The naming convention for the unit columns associated with the low/high values is: __ Each property type is separated by an underscore. In our example, this convention translates to: Standard_Age_Year Standard_Age_Year



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Global Unit Dictionaries Worksheet The Global Unit Dictionaries worksheet corresponds to the Global Unit Dictionaries section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Global Unit Dictionaries worksheet.

Global Unit Dictionaries Worksheet Property Name

Definition User-defined name for the Global Unit Dictionary. The worksheet is sorted in alphabetical order by Name. This property is required.

Active

If TRUE, the Global Unit Dictionary is set as active. If FALSE, the Global Unit Dictionary is set to inactive. This property is selected via a dropdown list and is required.

Global Unit Dictionary Entries The Global Unit Dictionary Entries worksheet corresponds to the Global Unit Dictionary Entries section in Lab Administration, as seen in the following screenshot.

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The following properties are displayed on the Global Unit Dictionary Entries worksheet.

Global Unit Dictionary Entries Worksheet Property Global Unit Dictionary

Definition User-defined name for the Global Unit Dictionary. The worksheet is sorted in alphabetical order by Global Unit Dictionary. This property is required, and is selected via a dropdown list. The dropdown’s contents are pulled from the Global Unit Dictionaries worksheet in the spreadsheet. A Global Unit Dictionary must exist on the Global Unit Dictionary worksheet in order for its name to exist in the dropdown list on the Global Unit Dictionary entries worksheet.

Ordinal

The position of the Global Unit Dictionary entry within the list of entries. This property is required.

User Data String

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

Standard

If TRUE, the Unit entry is the standard unit for the Global Unit Dictionary. At least one unit entry must be marked as TRUE. If FALSE, the Unit entry is not the standard unit. Selected via a dropdown list. This property is required.

Coded Unit

User-defined database value for the entry. This property is required.



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Global Unit Dictionary Entries Worksheet Property Constant A, B, C, K

Definition Each Constant will be listed in its own column in the worksheet. Each constant is part of the calculation used to convert the user-entered value from the user-specified unit into the standard unit, using the following formula: s = A / B (u + C) + K Where: s = standard value u = user value A = user-defined constant B = user-defined constant C = user-defined constant K = user-defined constant Example: s = 4 / 5 (u+8) + 0 In the above example: s = standard value u = user value A=4 B=5 C= 8 K=0

Active

If TRUE, the Global Unit Dictionary Entry is set as active. If FALSE, the Global Unit Dictionary Entry is set to inactive. Selected via a dropdown list. This property is required.

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Global Variables The Global Variables worksheet corresponds to the Global Variables section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Global Variables worksheet.

Global Variables Worksheet Property OID

Definition User-defined unique identifier for the Global Variable. The worksheet is sorted in alphabetical order by OID. This property is required.

Data Format

User-defined for the expected form of the data in the Global Variable. This property is required.

Global Data Dictionary

This property is required, and is selected from a dropdown list. The dropdown’s contents are pulled from the Global Data Dictionaries worksheet in the spreadsheet. A Global Data Dictionary must exist on the Global Data Dictionaries worksheet in order for its name to exist in the dropdown list on the Global Variables worksheet

Global Unit Dictionary

This property is required, and is selected from a dropdown list.

Active

If TRUE, the Global Variable is set as active.

The dropdown’s contents are pulled from the Global Unit Dictionaries worksheet in the spreadsheet. A Global Unit Dictionary must exist on the Global Unit Dictionaries worksheet in order for its name to exist in the dropdown list on the Global Variables worksheet.

If FALSE, the Global Variable is set to inactive. This property is selected via a dropdown list and is required.



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Lab Units Worksheet The Lab Units worksheet corresponds to the Lab Units section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Lab Units worksheet.

Lab Units Worksheet Property Name

Definition User-defined name for the Lab Unit. Each “master unit” and each synonym requires its own name and row in the spreadsheet. The worksheet is sorted in alphabetical order by Name. This property is required.

Parent Lab Unit

User-defined name for the “Master Unit”. This property is required.

Active

If TRUE, the Lab Unit is set as active. If FALSE, the Lab Unit is set to inactive. This property is selected via a dropdown list and is required.

Note: When

defining units, the “master unit” and each synonym must be specified in separate rows. For example, when defining the master unit “%”, and its synonym “PCT”, you would enter two rows in the spreadsheet. The first row would define the unit “%”. The second row would define the unit “PCT”, and would indicate that “%” is the Parent Lab Unit.

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Lab Unit Dictionaries The Lab Unit Dictionaries worksheet corresponds to the Lab Unit Dictionaries section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Lab Unit Dictionaries worksheet.

Lab Unit Dictionaries Worksheet Property Name

Definition User-defined name for the Lab Unit Dictionary. The worksheet is sorted in alphabetical order by Name. This property is required.

Active

If TRUE, the Lab Unit Dictionary is set as active. If FALSE, the Lab Unit Dictionary is set to inactive. This property is selected via a dropdown list and is required.

Lab Unit Dictionary Entries The Lab Unit Dictionaries Entries worksheet corresponds to the Lab Unit Dictionaries Entries section in Lab Administration, as seen in the following screenshot.



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The following properties are displayed on the Lab Unit Dictionary Entries worksheet.

Lab Unit Dictionary Entries Worksheet Property Lab Unit Dictionary

Definition User-defined name for the Lab Unit Dictionary. The worksheet is sorted in alphabetical order by Lab Unit Dictionary. This property is required, and is selected via a dropdown list. The dropdown’s contents are pulled from the Lab Unit Dictionaries worksheet in the spreadsheet. A Lab Unit Dictionary must exist on the Lab Unit Dictionary worksheet in order for its name to exist in the dropdown list on the Lab Unit Dictionary entries worksheet.

Unit

User-defined measurement for the Lab Unit Dictionary. This property is required, and is selected via a dropdown list. The dropdown’s contents are pulled from the Lab Units worksheet in the spreadsheet. A Lab Unit must exist in the dropdown list on the Lab Unit worksheet.

Active

If TRUE, the Lab Unit Dictionary Entry is set as active. If FALSE, the Lab Unit Dictionary Entry is set to inactive. This property is selected via a dropdown list and is required.

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Range Types Worksheet The Range Types worksheet corresponds to the Range Types section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Range Types worksheet.

Range Types Worksheet Property Name

Definition User-defined name for the Range Type. The worksheet is sorted in alphabetical order by Name. This property is required.

Active

If TRUE, the Range Type is set as active. If FALSE, the Range Type is set to inactive. This property is selected via a dropdown list and is required.

Range Type Variables Worksheet The Range Types Variables worksheet corresponds to the Range Types Entries section in Lab Administration, as seen in the following screenshot.



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The following properties are displayed on the Range Type Variables worksheet.

Range Type Variables Worksheet Property Range Type

Definition User-defined name for the Range Type. This property is required, and is selected via a dropdown list. The dropdown’s contents are pulled from the Range Types worksheet in the spreadsheet. A Range Type must exist on the Range Type worksheet in order for its name to exist in the dropdown list on Range Type Variables worksheet.

Global Variable

User-defined name for Global Variable. The Global Variable must match the OID on the Global Variables worksheet. Global Variable is required.

Low Value Label

User-defined name that describes the variable parameters being defined. For example, for the Global Variable “Age” the Low Label might be “From Age”. This property is required.

Low Value Match Operator

Operator used with the variable parameter being defined. Contents include Greater Than, Greater Than or Equal To, and Equal To. This property is required.

High Value Label

User-defined name that describes the variable parameters being defined. For example, for the Global Variable “Age” the High Label might be “To Age”.

High Value Match Operator

Operator used with the variable parameter being defined. Contents include Less Than and Less Than or Equal To. This property is required depending on the Low Value Match Operator that was selected. For example, if the Low Value Match Operator is >=, a High Value Match Operator of < or <= is required.

Low Value Default

User-defined value that will be displayed as the default low value.

Low Value Default Unit

Default unit that will be used for the default low value. The contents must match the Name on the Global Unit Dictionaries

High Value Default

worksheet. User-defined value that will be displayed as the default high value.

High Value Default Unit

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Default unit that will be used for the default high value. The contents must match the Name on the Global Unit Dictionaries worksheet.



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Range Type Variables Worksheet Property Active

Definition If TRUE, the Range Type Variable is set as active. If FALSE, the Range Type Variable is set to inactive. This property is selected via a dropdown list and is required.

The Range Type Variables worksheet is sorted by Range Type first, then by Global Variable. Note:



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Standard Groups Worksheet The Standard Groups worksheet corresponds to the Standard Groups section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Standard Groups worksheet.

Standard Groups Worksheet Property Name

Definition User-defined name for the Standard Group. The worksheet is sorted in alphabetical order by Name. This property is required.

Description

User-defined text that describes the Standard Group. This property is required.

Active

If TRUE, the Standard Group is set as active. If FALSE, the Standard Group is set to inactive. This property is selected via a dropdown list and is required.

Standard Group Entries Worksheet The Standard Groups Entries worksheet corresponds to the Standard Groups Entries section in Lab Administration, as seen in the following screenshot.

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The following properties are displayed on the Standard Group Entries worksheet.

Standard Group Entries Worksheet Property Standard Group

Definition User-defined name for the Standard Group. This property is required and is selected via a dropdown list. The dropdown’s contents are pulled from the Standard Groups worksheet in the spreadsheet. A Standard Group must exist on the Standard Group worksheet in order for its name to exist in the dropdown list on Standard Group Entries worksheet.

Unit

User-defined units for each of the Analytes that are part of the selected Standard Group. The Unit must match the Unit from the Lab Units worksheet. This property is required.

Analyte

Active

User-defined Analytes that are part of the Standard Group. The Analyte must match the Analyte from the Analytes worksheet. Analyte is required. If TRUE, the Standard Group entry is set as active. If FALSE, the Standard Group entry is set to inactive. This property is selected via a dropdown list and is required.

The Standard Group Entries worksheet is sorted by Standard Group first, then by Analyte. Note:



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Unit Conversions Worksheet The Unit Conversions worksheet corresponds to the Unit Conversions section in Lab Administration, as seen in the following screenshot.

The following properties are displayed on the Unit Conversions worksheet.

Unit Conversions Worksheet Property From Lab Unit

Definition User-defined units that is to be converted into the To Lab Unit. The From Lab Unit must match the Lab Unit in the Lab Units worksheet. This property is required.

To Lab Unit

User-defined Master units. The To Lab Unit must match the Lab Unit in the Lab Units worksheet. The From Lab Unit and the To Lab Unit must be different. This property is required.

Applicable Analyte

User-defined Analyte that can be used in the conversion. The Applicable Analyte must match the Analyte name in the Analytes worksheet.

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Unit Conversions Worksheet Property Constant A, B, C, K

Definition Each Constant will be listed in its own column in the worksheet. Each Constant is part of the calculation used to convert the From Lab Unit into the To Lab Unit, using the following formula: t = A / B (f + C) + K Where: t = to unit f = from unit A = user-defined constant or Analyte B = user-defined constant or Analyte C = user-defined constant K = user-defined constant Example: t = 1 / 1000 (f + 0) + 0 In the above example: t = to unit f = from unit A=1 B = 1000 C= 0 K=0

Top Analyte In Formula

The Analyte name that is to be used as part of the formula.

Bottom Analyte In Formula

The Analyte name that is to be used as part of the formula.

Active

If TRUE, the Unit Conversion is set as active. If FALSE, the Unit Conversion is set to inactive.

If the formula is t = WBC / 1 (f+0) + 0, then the WBC is the Top Analyte in Formula.

If the formula is 1 / WBC (f+0) + 0, then the WBC is the Bottom Analyte in Formula.

This property is selected via a dropdown list and is required.



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Example: Adding a New Analyte and a Lab Unit Dictionary The following example will demonstrate how to add new lab settings to the spreadsheet. We will add a new Analyte, “Calcium” to the spreadsheet. The Calcium Analyte will include the “Calcium” Lab Unit Dictionary. Before we begin adding new lab settings, we need to determine the order i n which we are going to build them. A Lab Unit Dictionary is a property of an Analyte, so we need to build the Lab Unit Dictionary before we build the Analyte. Lab Unit Dictionaries consists of multiple entries; therefore we need to build the Lab Unit Dictionary entries after building the Lab Unit Dictionary. 1. Building the Lab Unit Dictionary: on the Lab Unit Dictionaries worksheet, we enter the new dictionary name and select TRUE for the Active flag.

2. Building the Lab Unit Dictionary entries: on the Lab Unit Dictionary entries worksheet, we use the Lab Unit Dictionary dropdown list to select the Calcium dictionary, and enter the entry properties into their respective columns. Each entry is entered into its own line, each line referencing the Calcium dictionary.

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3. Building the Analyte: on the Analytes worksheet, we enter the new Analyte name in the Name column. In the Lab Unit Dictionary column, we select the Calcium dictionary from the dropdown list. This assigns the dictionary to the Analyte. Enter all properties for the Analyte in their respective columns.

4. Save the changes using the 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 accidental edits and unwanted deletions, worksheets are 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. 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.

When editing or deleting data you will need to keep data dependencies in mind. For example, if you delete a Global Data Dictionary, you need to also delete the Global Data Dictionary entries. You also need to remove any reference to that Global Data Dictionary. Luckily, even if you forget to delete dependencies the system will remind us. When you attempt to upload the spreadsheet and there are dangling object references – such as references to deleted items – you will receive detailed error messages letting you know where those errors exist.

When entering or modifying dates in the spreadsheet, you must follow a specific date convention: yyyy mm dd. For example, April 15 2008 will be 2008 04 15 in the spreadsheet. Note:

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Uploading a Draft This chapter will cover the following topics: 

The Upload Process



Uploading a Spreadsheet



Understanding the Upload Process Page



Errors in the Upload Process



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The Upload Process The Lab Loader spreadsheet can be uploaded into a Rave database for various results. 

A spreadsheet can be uploaded into the same database from which it was extracted to update existing lab settings.



A spreadsheet can be uploaded into a separate Rave database to update existing lab settings, or to create new settings in addition to the existing ones.



A spreadsheet can be uploaded into a separate blank Rave database to create new lab settings.

The upload process updates the settings in Lab Administration with the data on the spreadsheet. Once the contents of the spreadsheet are uploaded, they can be maintained through the Lab Administration module. There are three types of upload. The system determines which type of upload to perform based on the settings defined in the Upload section of Lab Loader. 

Merge: If the lab settings exist in the target database and the Overwrite checkbox is not checked, the spreadsheet contents are merged with the data that already exists in the database. During a merge, the content in the spreadsheet takes precedence and overwrites the lab settings. Lab settings that are specified with the Active flag to FALSE in the worksheet are inactivated in Rave upon the upload. Merge is the default setting when uploading.



Overwrite: If the lab settings exist in the target database and the Overwrite checkbox is checked, the existing settings in the target database are deleted and replaced with the content in the spreadsheet. There is an exception to this rule. If a specific property is in use, it cannot be modified or deleted. For example, if a Clinical Significance Code is used on a lab form in EDC the code cannot be modified or deleted. However the Clinical Significance Code description can be modified, even if it is used on an EDC lab form. Any lab setting that is not in use will be inactivated in the beginning of the upload process.



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New Lab Settings Creation: If lab settings are not defined in the target database, the system will create new settings in the target database. The Overwrite flag is ignored because the lab settings do not exist.



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Uploading a Spreadsheet Once the worksheets have been completed, the lab settings can now be uploaded to the target database.

Data in the spreadsheet is uploaded in the user’s locale, which is specified in the My Profile section. Note:

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

2. In the sidebar of the Lab Administration main page, click the Lab Loader link.

3. From section, buttonNote to search for and locatethe theUpload spreadsheet fileclick thatthe willBrowse be uploaded. that files can be compressed (.zip).



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4. Once the file has been located and selected, the path to the file is displayed in the Select File textbox.

Note:

The following file types can be uploaded: .zip, .xls, and .xml.

5. If necessary, check the Overwrite checkbox. Refer to the “The Upload Process” section of this manual for more information on the Overwrite setting.

6. Click Upload to begin the uploading process. 7. 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 this manual.

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Understanding the Upload Process 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 has not been uploaded



A checkmark icon indicates an object type has been successfully uploaded



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 uploaded.



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

When a successful upload occurs, all objects that were uploaded display the checkmark icon, and the event log includes any non-rollback events. A rollback event is any issue found in the spreadsheet that will prevent the system from saving the uploaded content. In the case of a rollback, no changes are made to the target draft. Refer to the “Errors 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 Lab Loader main page.

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When the upload is in Overwrite mode, the event log will indicate when the overwrite process begins and ends as well as when the upload process starts and ends. The event log will indicate the number of unused objects that were removed during the overwrite upload.



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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 Lab Administration. If the system encounters a validation error the upload process fails and no changes are made to the target database. 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. The following are some common conditions that generate errors, causing a transaction rollback: 

Overlapping lab ranges specified on the Analyte Ranges worksheet. For example, specifying a Hematocrit range for Males between the ages of 12 and 30 and another Hematocrit range for Males between the ages of 15 and 20.



Inactivating an object in the spreadsheet when the object is currently in use in EDC. For example, inactivating a Clinical Significance Code when it is in use on a lab form in EDC.

If all objects, in the spreadsheet, have been successfully validated, all objects will be uploaded to the target database. If a rollback occurs, the upload process page displays all errors – in collapsible format – by encountered during the uploaded, Each prefixed its corresponding worksheet rowseparated number. by Forobject. example, theerror errorwill be message below is stating there are overlapping ranges for row 19.

Referring back to the spreadsheet, navigate to the appropriate worksheet and locate the row in question.

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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. This allows you to correct all errors before attempting another upload.

Any data that is unacceptable in Lab Administration is unacceptable in the Lab Loader. Note:

To View Errors Encountered During the Upload Process: 1. Upload a spreadsheet using the steps outlined in the previous sections of this manual. Any objects that encountered errors during the 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 objects in the spreadsheet. 4. Repeat the upload process until all errors have been resolved.



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

Downloading a Spreadsheet Template



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Downloading a Spreadsheet Template A blank template of a spreadsheet can be downloaded from the Download section of the main Lab Loader page. The template contains all the object worksheets, including column headings and sort capability. The template can be used to develop lab settings offline, and can then be uploaded into the Rave system. Although Analyte Ranges can be defined directly on the spreadsheet, it is recommended that they be defined within the Rave system for efficiency. The spreadsheet template is downloaded in a compressed (.zip) Excel file, with an .xls extension.

To Download a Spreadsheet Template: 1. Navigate to the Lab Loader main page by clicking on the Lab Loader link on the sidebar of the Lab Administration module.

2. Select Blank Template from the Select Sheet dropdown list. 3. Click the Download button.



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4. A pop-up window is displayed. Click Save to save the zip file containing the template.

5. The filename defaults to Blank_Template_yyyy_mm_dd.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.

6. When the download is complete, navigate to the location where the file is saved, and double-click the .zip file to launch.

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7. The Blank_Template_yyyy_mm_dd.xls spreadsheet file is displayed in the zip window. Double-click the filename to launch the Excel spreadsheet.



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