563 PDF Generator Final

Medidata Rave® 5.6.3

PDF Generator Module 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

PDF Generator Module

Revision History Version

Date

1.0

January 2007

2.0

June 2007

3.0

October 2007

Changed by Carrie Barent Training Specialist Dana Cooperman, Instructional Designer Carrie Barent, Instructional Designer

Description of Changes Original Release

Update to 2nd-Tier Audit Category definition.

5.6.2 Updates: •

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4.0

May 2008

Rick Raguso, Instructional Designer

Permission change in viewing PDFs in My PDF Files page Removal of configuration settings

Miscellaneous text/grammar changes 5.6.3 Updates: •

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Scheduled Execution Date/Time Sample Screenshots: Blank PDF Document with Annotations

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 t o, 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 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 ............................... ................................................................ ................................................... .................. 5 Using This Manual ......................... ...................................... .......................... .......................... ......................... .........................5 .............5

Introduction to the PDF Generator Module ............................... 7 Process for Generating a PDF Document ........................... ......................................... ............................8 ..............8

Generating PDF Files ................................. ................................................................ ............................... 9 Accessing the PDF Generator Module ......................... ..................................... ......................... .....................11 ........11 My PDF Files Page ......................... ...................................... ......................... ......................... .......................... ........................12 ...........12 Accessing the My PDF Files Files Page .................................................................12 My PDF PDF Files Files Definitions .............................................................................12 Downloading and and Viewing a PDF File File ............................................................13 Blank PDF Files .......................... ....................................... .......................... .......................... .......................... ..........................1 .............16 6 Accessing the Create Blank Request Page .....................................................16 Blank PDF File File Parameters: Definitions .........................................................17 Creating Blank PDF File File Requests ................................................................20 Data PDF Files .......................... ....................................... .......................... .......................... .......................... .......................... ...............22 ..22 Accessing the Create Data Request Page ......................................................22 Data PDF File Parameters: Parameters: Definitions ..........................................................22 Creating Data PDF File Requests..................................................................26 File Requests Page ......................... ...................................... .......................... ......................... ......................... .......................28 ..........28 Accessing the the PDF File File Requests Page Page ..........................................................28 Searching for PDF File Requests ..................................................................29 Search Criteria Definitions ..........................................................................29 Viewing and Editing File Request Parameters.................................................31 File Requests Definitions ............................................................................31 Using “Generate Now” for Existing File Requests............................................33 Cloning File Requests.................................................................................34 Deleting File Requests ...............................................................................35 Batch Scheduling PDF File Requests .............................................................37

Appendix A: Sample PDF Documents ................................... ...................................... ... 39 Sample Cover Page ........................ .................................... ......................... .......................... ......................... .......................41 ...........41 PDF Cover Page and and Bookmarks.................................................................. 41 Sample Blank PDF Document ......................... ...................................... .......................... ........................... ...................42 .....42 Blank eCRF ..............................................................................................42 Blank PDF Document with Annotations .........................................................43 Sample Data PDF Document............ Document ......................... .......................... .......................... .......................... .....................44 ........44 eCRF With Data ........................................................................................44 Audit Trail ................................................................................................45



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Welcome This manual is designed to be a useful and detailed reference for the PDF Generator 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: •

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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 specific link or button, a picture 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 PDF Generator Module When sponsors submit applications to the FDA for review, they are required to submit all the paper CRF CRF forms for subjects that participated in the study. study. The PDF Generator provides users the ability to produce submission-ready Portable Data format (PDF) files with audit trail data that is extracted directly from the EDC database. Functionality includes a process for users to specify PDF parameters parameters and submit a PDF file request, globally configurable PDF request parameters, a program that generates the PDF files and allows the job to be scheduled, and a mechanism that stores the generated files for user retrieval. By using the PDF Generator module, sponsors or Contract Research Organizations can significantly reduce the time and cost that is traditionally required to prepare a complete paper-based CRF book for regulatory submission. Within the EDC module, end users can: 

Produce a PDF document for a single form.

Within the PDF Generator module, users can: 

Create PDF Requests that will generate PDF documents for subjects by specifying a study, site, role, locale, site group, or a set of selected subjects. This will produce a PDF document for all the forms for for a subject.

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Schedule existing PDF Requests to run on a specified date and time, thereby allowing the jobs to run in off hours in order to avoid affecting site performance.

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View and download generated PDF files based on Role permissions.

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Generate blank PDFs containing blank Case Report Forms for a specified study, CRF version, role, locale, and based on t he default matrix of that CRF version. version. Annotations can be included in blank study PDFs.

Note: When generating a PDF, whether from EDC or the PDF Generator module, the PDF profile will dictate the group of global settings that will be used.



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Process for Generating a PDF Document The workflow below explains the process of creating and configuring PDF Profiles and PDF Files.

Create a PDF Profile in the Configuration module

Configure profile settings in the Configuration module

Create a blank or data PDF in the PDF Generator module

Generate unscheduled PDFs, if needed from the File Requests page

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Open the PDF documents for viewing or save to a location from the My PDF Files page



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Generating PDF Files This chapter will cover the following topics: 

Accessing the PDF Generator Module

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MY PDF Files Page

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Blank PDF Files

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Data PDF Files

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File Requests Page



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Accessing the PDF Generator Module Once profiles have been defined, PDF files can be generated and downloaded using Rave’s PDF Generator module. Users must have at least one of the following permissions in order to access the PDF Generator module: •

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PDF Request Manager: enables Manager: enables a user to add, edit, schedule or execute PDF file requests. PDF File Access: enables Access: enables a user to download and access the My PDF Files page. PDF File Deletion: enables Deletion: enables a user to delete PDF File Requests or generated PDF files.

Note: User permissions are set in the User Groups section of the Configuration module. Refer to the Configuration Configurati on Module Training Manual for additional information.

To Access the PDF Generator Module: 1. Select PDF Generator Generator from the list of Installed Modules on the Homepage.

2. The PDF File Request page is displayed by default.



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My PDF Files Page The My PDF Files page is used to download PDF files that have already been generated via the PDF Generator. Generator. The My PDF Files page page takes Rave data security into account so that you will only see PDF files that you are “allowed” to see, based on the user-role and associated permissions. In order to view a Data PDF in PDF in the My PDF Files page you must be: 

Assigned to a User Group with access to the PDF Generator module

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Assigned to the role permission of ViewAllSitesinSiteGroup

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Assigned to the World site group

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Assigned to the study and role the PDF file was generated for

In order to view a Blank PDF in PDF in My PDF Files page you must be: 

Assigned to a User Group with access to the PDF Generator module

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Assigned to the project you wish to view/download with an Architect Security Role that has the permission to download.

Accessing the My PDF Files Page From within the PDF Generator module, the PDF G enerator page can be accessed at any time by clicking the My PDF Files link Files link in the sidebar.

The My PDF Files page is displayed:

My PDF Files Definitions •

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All Files: radio Files: radio button (selected by default). default). When selected, updates updates the list of PDF files displayed on the My PDF Files page to include all PDF Files that you have access to (blank and data-filled). PROPRIETARY – LIMITED DISTRIBUTION


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Blank PDF Files: radio Files: radio button. When selected, updates the list of PDF files displayed on the My PDF Files page to include only the blank PDF files that you have access to. PDF Files with Data: radio Data: radio button. button. When selected, updates the list of PDF files displayed on the My PDF Files page to include only the data-filled PDF files that you have access to.

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Name: the Name: the name of the PDF file.

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Description: the Description: the description of the PDF file.

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Created: the Created: the date and time the PDF file was generated.

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Download: disk Download: disk icon. When clicked, you will be prompted to open or save a compressed file containing the PDF. Delete: icon. Delete: icon. When clicked, the you delete the selected selected PDF file request. You must must confirm the deletion.

Downloading and Viewing a PDF File PDF Files can be viewed and/or downloaded via the My PDF Files page.

To Download a PDF File: 1. From the My PDF Files page, locate the desired PDF file.

Tip: To reduce the number of PDF files displayed on the page, use the radio buttons along the top of the main area to view only those PDFs that are blank, or only those PDFs that contain data. 2. Click the Download icon Download icon to right of the desired PDF file.



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3. The system displays a prompt, requesting that you save a compression (zip) file containing the selected PDF. Click Save Save to save the compressed files, or click Cancel to Cancel to quit without saving.

4. Upon clicking Save, Save, the you are prompted to select the location where the compressed file should should be saved. Navigate to the desired location, update the file name if desired, and click Save. Save.

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5. To view the PDF files, navigate to the location outside of Rave to where the files were were saved. saved. Double-click on the compressed file (*.zip) to launch. Extract the PDF files to the desired desired location, and view the files with Adobe Acrobat reader. Adobe Acrobat reader 5.0 or higher is required to read PDF files.



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Blank PDF Files You can select PDF parameter profiles (defined globally in the Configuration module) for the generation of blank (without (without data) PDF File Requests. Once blank PDF parameters have been selected, you can save the request, generate the request, or schedule a date/time in the future when the request will be generated.

Accessing the Create Blank Request Page The Create Blank Request page can be accessed from within the PDF Generator module by clicking the Create Blank Request link Request link in the sidebar.

Note: The Create Blank Request Page can also be accessed using the hyperlink Create Blank Request located at the bottom of the File Requests page.

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The Blank PDF file request page is displayed.

Blank PDF File Parameters: Definitions •

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Name: User-defined Name: User-defined identifier for the PDF File Request. Name is required, may be a maximum of 50 characters, and must be unique. Description: User-defined Description: User-defined description for the PDF File Request (optional.) Description is limited to a maximum of 255 characters. characters. Scheduled Execution Date/Time: calenda Date/Time: calendarr tool/text box. You can can use the calendar tool to specify the date/time at which the PDF file will be generated. Clicking in the Date text box displays a calendar allowing you to choose a date; you can then enter a time (24 hour clock or 12 hour clock) into the time field, followed by the am or pm meridian if using a 12 hour clock. clock. If no date/time is specified, the file request is saved with a status of “Unscheduled.”

Clear: link. Clear: link. When clicked, removes removes any date/time date/time criteria that have been entered into the Scheduled Execution Date/Time fields. Configuration Profile: dropdown Profile: dropdown list. Used to specify specify which specific PDF Profile will be used to create the blank PDF file (required.) Profiles are created in the Configuration module. Study: dropdown Study: dropdown list. Used to specify specify which study the PDF will be generated for (required.) (required.) Studies are listed by Study Name – Environment, and all all studies for an an installation are are listed. You may select only one study per PDF File Request.



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Role: dropdown Role: dropdown list. Used to specify the role the PDF request is to be run for (required.) (required.) Only users within within this selected role will be able to access/download access/download the PDF file via the My PDF Files page once it has been generated. The dropdown list list displays all the roles available available in the selected study, and based on the selected role, the CRF Version dropdown list (see below) is populated. Locale: dropdown Locale: dropdown list. Used to specify specify the locale (language) (language) in which which the PDF should be generated (required). (required). The dropdown defaults defaults to the installation’s default locale; the list contains all available locales. CRF Version: dropdown Version: dropdown list. list. Used to specify the version of the CRF for which the PDF should be generated (required.) You may generate generate a blank PDF for only one CRF CRF version. Once you have selected selected a Study, the CRF Version list is populated with all of the CRF Versions available for that study, listed by CRF Version Version Name (Number). When a CRF Version is selected, the Matrix dropdown list is populated as seen below. Matrix: dropdown Matrix: dropdown list. list. Used to specify a matrix within the selected CRF Version that the PDF should should be generated generated for (required.) Only one matrix may be selected from the dropdown list; the dropdown defaults to the default default matrix for the selected CRF Version. Once a matrix is selected, the Folder/Form Exclusions lists (see below) are updated to contain only folders and forms available in the selected matrix.

Note: If you wish to include all folders/forms (whether (whether hidden or added dynamically) you can create a “PDF Matrix” that includes everything in the CRF Version. This “PDF Matrix” would then be available available for selection when generating generating PDF Files.

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Folder Exclusions: The Exclusions: The folder exclusions panel is collapsed (hidden) by default. Click the arrow link to link to expand the panel to display a list of folders and checkboxes. This panel panel is used to specify which (if any) folder(s) should be excluded when the PDF is generated. When the Folder Exclusions list is expanded by clicking on the arrow link, link, all folders for which the selected Role has the appropriate view permissions and which are contained in the selected matrix are shown. The folders are are sorted alphabetically alphabetically by Folder Name. Name. You can select select folders to be excluded by checking the box to the left of the folder name. Folders can be be de-selected, and and therefore included, by unchecking the box. box. If a folder is excluded, all forms within the folder, as well as all child folders/forms within the folder are also excluded. Checking the box at the top of the list automatically selects all folders for exclusion. Unchecking the box automatically deselects deselects all folders.

To search for a specific folder, enter the folder name in the textbox at the top of the Folder Exclusions list and click the search icon (magnifying glass) to locate the folder. Form Exclusions: The form exclusions panel is collapsed (hidden) by default. It is used to specify specify which (if any) form(s) should be excluded when the PDF is generated. When the Form Exclusions list is expanded by clicking on the arrow link, link, all forms for which the selected Role has the appropriate view permissions are are shown. The forms are sorted alphabetically alphabetically by Form Name. You can select forms forms to be excluded by checking the box to the left of the form name. Forms can be de-selected by unchecking unchecking the box. box. Checking the box at the top of the list automatically selects all forms for exclusion. Unchecking the box automatically automatically deselects all forms. forms. If a form is in a folder that has been excluded, the form will not be included when the PDF is generated, and thus does not need to be explicitly selected in the Form exclusions list for exclusion. exclusion. To search for a specific specific form, enter the form name in the textbox at the top of the Form Exclusions list and click the search icon (magnifying glass) to locate the form.



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Creating Blank PDF File Requests Blank PDF File Requests are created on the Create Blank Request page in the PDF Generator module.

To Create a Blank PDF File Request: Refer to the definitions and explanations on the previous pages for additional information. 1. Click the Create Blank Request link Request link in the PDF Generator sidebar to display the Blank PDF page. 2. Enter a unique PDF File Request Name, and select additional parameters as as needed. Refer to the definitions listed listed on the previous previous pages for explanations of all parameters.

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3. Click Save to create the Blank PDF File Request and return to the PDF File Request page, where the request is now available in the File Requests list. Click Cancel to return to the PDF File Request page without saving.

4. Upon clicking Save, Save, if the system detects that the PDF File has been scheduled for a date/time that is in the past, a prompt is displayed for indicating that the File Request will be placed in the queue for immediate generation. Click OK OK to proceed with the immediate generation, or click Cancel to return to the Blank PDF parameter selection page and edit the scheduled date/time.

Note: If the Scheduled Date/Time parameter is left blank, the PDF File Request is saved with a status of “Unscheduled”. “Unscheduled”. To schedule a date/time date/time for the request request to be run, locate the Unscheduled request on the File Request page, and use the edit pencil icon to edit the parameters.



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Data PDF Files You can select PDF parameter profiles (defined globally in the Configuration module) for the generation of data-filled data-filled PDF File Requests. Once PDF parameters parameters have been selected, you can save the request, generate the request, or schedule a date/time in the future when the request will be generated.

Accessing the Create Data Request Page The Create Data Request page can be accessed from within the PDF Generator module by clicking the Create Data Request link Request link in the sidebar.

Note: The Create Data Request Page can also be accessed using the hyperlink Create Data Request located at the bottom of the File Requests page. The Data PDF file request page is displayed.

Data PDF File Parameters: Definitions •

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Name: User-defined identifier for the PDF PDF File Request. Request. Name is required, limited to a maximum of 50 characters, and must be unique.



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Description: User-defined description for the PDF File Request (optional.) Description may be a maximum of 255 characters. characters. Scheduled Execution Date/Time: calendar tool/text box. box. You can can use the calendar tool to specify the date/time at which the PDF file will be generated. Clicking in the Date text box displays a calendar allowing you to choose a date; you can then enter a time (24 hour clock or 12 hour clock) into the time field, followed by the am or pm meridian if you are using a 12 12 hour clock. If no date/time is specified, the file request is saved with a status of “Unscheduled.”

Clear: link. When clicked, removes removes any date/time date/time criteria that that has been entered into the From/To Date/Time fields. Configuration Profile: dropdown list. Used to specify specify which specific PDF Profile should be used to create the blank PDF file (required.) Profiles are administered in the Configuration module. Study: dropdown list. Used to specify specify which study the PDF should be generated for (required.) (required.) Studies are listed by Study Name – Environment, and all all studies for an an installation are are listed. You may select only a single study per PDF File Request. Role: dropdown list. Used to specify the role the PDF PDF request is to be run for (required.) (required.) Only users within within this selected role will be able to access/download access/download the PDF file via the My PDF Files page once it has been generated. For example, if a PDF is generated generated for a Data Manager role for the Mediflex study, the data in the PDF is restricted to contain only information the Data Manager role has permission to see within that study. Only users that that are assigned assigned to the Mediflex study study as Data Manager will be able to t o access/download that PDF file (via the My PDF Files page) once it is generated. The dropdown list displays displays all roles available in the selected study, and based on the selected role, the CRF Version dropdown list (see below) is populated. Locale: dropdown list. Used to specify the locale (language) (language) in which the PDF should be generated (required.) (required.) The dropdown defaults defaults to the installations default locale; the list contains all available locales.



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Site Groups and Sites: checkboxes. Used to choose the the Site Group(s) that the the PDF should be generated for. Site Groups are only listed if they include sites in the selected study (e.g. the Site Group “North America” is only listed if the selected selected study contains sites sites within that Site Group.) Site Groups are listed alphabetically by Site Group Name. If a Site Group contains Sub-Site Sub-Site Groups, those those Sub-Site Groups can be viewed by clicking the plus sign to the left of the Site Group name. Sub-Site Groups are are displayed slightly indented from the parent Site Group. If a Site Group is selected, selected, all sub-Site groups are automatically selected selected by the system. system. You may deselect deselect as needed by unchecking the box to the left of the Site Group or Sub-Site Group name. You may select select one or more more Site Groups by checking the box(es) to the left of the Site Group name.

Subjects: The subjects panel is collapsed (hidden) by default. Click the arrow link to expand the panel to display a list of subjects. subjects. The subjects panel is used to select the specific subjects for which the PDFs should be generated. The subjects in the list are associated associated with the the selected Sites, assuming assuming a Site has been selected. If no Sites have have been selected, the list of subjects includes all subjects in the selected Site Group. If no Site Group is selected, then all subjects in the selected Study are displayed. To search search for a specific specific subject, enter the subject name in the textbox at the top of the subject list and click the search icon (magnifying glass) to locate the subject.

Note: The list of subjects contains only subjects that the selected role has permission to see.

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Folder Exclusions: The Exclusions: The folder exclusions panel is collapsed (hidden) by default. Click the arrow link to expand the panel to display a list of folders and checkboxes. It is used to specify which (if any) folder(s) should be excluded when the PDF is generated. When the Folder Exclusions list is expanded by clicking on the arrow link, link, all folders for which the selected Role has the appropriate view permissions are shown. The folders are sorted alphabetically by Folder Name. You can can select folders to be excluded by checking the box to the left of the folder name. Folders can can be de-selected by unchecking unchecking the box. If a folder is excluded, all forms within the folder, as well as all child folders/forms within the folder are also excluded. Checking the box at the top of the list automatically selects all folders for exclusion. Unchecking the box automatically deselects all folders.

To search for a specific folder, enter the folder name in the textbox at the top of the Folder Exclusions list and click the search icon (magnifying glass) to locate the folder. •

Form Exclusions: The form exclusions panel is collapsed (hidden) by default. It is used to specify specify which (if any) form(s) should be excluded when the PDF is generated. When the Form Exclusions list is expanded by clicking on the arrow link, link, all forms for which the selected Role has the appropriate view permissions are are shown. The forms are sorted alphabetically alphabetically by Form Name. You can select forms forms to be excluded by checking the box to the left of the form name. Forms can be de-selected by unchecking unchecking the box. box. Checking the box at the top of the list automatically selects all forms for exclusion. Unchecking the box automatically automatically deselects all forms. forms. If a form is in a folder that has been excluded, the form will not be included when the PDF is generated, and thus does not need to be explicitly selected in the Form exclusions list for exclusion. exclusion. To search for a specific specific form, enter the form name in the textbox at the top of the Form Exclusions list and click the search icon (magnifying glass) to locate the form.



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Creating Data PDF File Requests Data PDF File Requests are created on the Create Data Request page in the PDF Generator module.

To Create a Data PDF File Request: Refer to the definitions and explanations on the previous pages for additional information. 1. Click the Create Data Request link Request link in the PDF Generator sidebar to display the Data PDF page. 2. Enter a unique PDF File Request Name, and select additional parameters as needed. Refer to the definitions listed on the previous pages for explanations of all parameters.

3. Click Save to create the Data PDF File Request and return to the PDF File Request page, or click Cancel to return to the PDF File Request page without saving.

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4. Upon clicking Save, Save, if the system detects that the PDF File has been scheduled for a date/time that is in the past, a prompt is displayed indicating that the File Request will be placed in the queue for immediate generation. Click OK OK to proceed with the immediate generation, or click Cancel to return to the Data PDF parameter selection page and edit the scheduled date/time.

Note: If the Scheduled Date/Time parameter is left blank, the PDF File Request is saved with a status of “Unscheduled”. “Unscheduled”. To schedule a date/time date/time for the request request to be run, locate the Unscheduled request on the File Request page, and use the edit pencil icon to edit the parameters.



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File Requests Page The PDF File Request page allows allows you to manage manage PDF file requests. From this page, you can: 

View a list of any previously saved PDF file requests

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Edit and/or execute user-saved file requests

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Add new file requests

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Schedule requests to run in the future

Accessing the PDF File Requests Page The PDF File Request page is displayed by default when you access the PDF Generator module. To access the PDF PDF File Request page, use the PDF Generator module link on the Rave Homepage. Homepage. From within the the PDF Generator module, the PDF Generator page can be accessed at any time by clicking the File Requests link Requests link in the sidebar.

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The File Requests page is displayed:

Searching for PDF File Requests You can search for PDF File Requests using the Search Criteria section of the File Request page. By default, the search parameters parameters are are blank and all file requests are displayed in the File Request section of the page.

Search Criteria Definitions •

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File Request Name: text Name: text box. You can search for a file request or group of requests by entering the name of the request. Status: dropdown list. You can select select the status of the request being searched for. Statuses include: All (default setting), Unscheduled, Scheduled, In Progress, Completed, or Execution Error. Type: dropdown list. You can select select whether to search for blank PDF requests or data-filled data-filled requests, or or all types of PDF requests. All is selected by default. Created By: dropdown list. You can select select to view only requests created by a specific first/last name. Date: radio buttons. You can choose to search for file requests based on the date the PDF was created, or on the date the PDF has been scheduled (default).



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From/To Date/Time: calendar tool/text tool/text box. You can can use calendar calendar tools to specify a date range to narrow down the scope of the PDF files returned during a search. Clicking in the Date text box displays displays a calendar to choose a from/to date, and you can enter a time (24 hour clock or 12 hour clock) into the time field, followed by the am or pm meridian if you are using the 12 hour clock.

Clear: link. When clicked, removes removes any date/time date/time criteria that that has been entered into the From/To Date/Time fields. Configuration Profile: dropdown list. You can select to search for PDF requests created with a specific PDF Profile (profiles are administered in the Configuration module). Search: link/icon. Search: link/icon. When clicked, executes a search based on the parameters selected in the Search Criteria section of the PDF File request page. The search parameters are linked using “AND” functionality, therefore results of the search will match all the criteria selected.

To Search for PDF File Requests: Refer to the definitions and explanations on the previous pages for additional information. 1. Access the PDF File Request page by clicking on the PDF Generator link on the Rave Homepage, and by clicking on the File Requests link within the PDF Generator module. 2. In the Search Criteria section, specify the desired search parameters. Refer to the definitions in the previous section for descriptions of the search parameters.

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3. Click Click Search Search to submit the search request. The results of the search search are displayed in the File Requests section of the screen.

Note: The results of File Request searches can be sorted by double-clicking on any of the column headings (Name, Description, Profile, Created, Updated, Scheduled and Status) Viewing and Editing File Request Parameters File Requests can be viewed, edited, regenerated, and cloned in the File Request section of the File Request page.

File Requests Definitions •

Name: the Name: the name of the file request

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Description: Description: user-saved description of the file request

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Profile: profile Profile: profile used to generate the file request

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Created By: name By: name of the user that created the file request

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Created: the Created: the date/time the file request was created

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Scheduled: the Scheduled: the date/time the file request was/is scheduled to be run

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Status: the Status: the status of the file request. request. Status can be Completed, Scheduled, Unscheduled, In Progress, or Execution Error Edit pencil: icon. pencil: icon. When clicked, you can edit file request request parameters parameters and scheduled execution times Generate Now: icon. When clicked, the the PDF file is placed into the queue for generation. generation. You are warned warned that generating generating PDF files may may tax system resources. Clone: icon. Clone: icon. When clicked, you can make a copy of a PDF file request and save it with a new name and execution time. All parameters may be edited. Delete: icon. Delete: icon. When clicked, you you will delete the selected selected PDF file request. You must must confirm the deletion. Live Status Update: checkbox. If checked, refreshes the “status” column on the File Request page every 10 seconds.



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To View or Edit File Request Parameters: Refer to the definitions and explanations on the previous pages for additional information. 1. Locate the desired file request by performing a File Request search. Refer to the previous section for details. 2. Click the Edit Pencil icon next to the desired File Request to view/edit File Request Parameters.

3. The File Request parameters parameters are displayed. displayed. All parameters parameters can can be edited, except for Name and Description, Description, which are grayed out. out. Refer to the Blank PDF Parameters and Data PDF Parameters sections of this manual for details on File Request parameters.

4. Click Save Save to save the parameters, or click Cancel to close the file request without saving. Check the Delete checkbox and click Delete to permanently remove the file request from the system.

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Using “Generate Now” for Existing File Requests PDFs can be generated immediately for existing File Requests by using the Generate Now icon. When Generate Now is clicked, the File Request is automatically placed into the queue for regeneration. regeneration. You are prompted with a reminder that generating PDFs may tax system resources.

To Generate a PDF from an Existing File Request 1. Locate the desired file request by performing a File Request search. Refer to the Searching for PDF File Requests section for details. 2. Click the Generate Now Now icon to the right of the desired PDF File Request.

3. The system displays a prompt indicating that generating a PDF file may be taxing on on server resources. resources. To continue, click click OK. OK. To cancel, click Cancel. Cancel .

4. Upon clicking OK, OK, the file request is placed into the queue for PDF generation.



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Cloning File Requests File Requests can be copied using the Clone functionality Clone functionality on the PDF File Request page. Cloning requests are useful useful when you may have multiple file requests that contain many of the same parameters. Rather than creating each request from scratch, you may clone the request and edit the name and parameters in the new copy as needed. Cloning functionality is similar similar to “Save-as” functionality functionality found in commonly used software applications.

Note: When the same PDF file may be needed in multiple multiple locales, create a single single file request with with the necessary parameters. parameters. Then use the Clone feature feature to create additional requests and change the locales as needed.

To Clone a File Request: 1. Locate the desired file request by performing a File Request search. Refer to the Searching for PDF File Requests section for details. 2. Click the Clone icon Clone icon to the right of the desired PDF File Request.

3. The system displays a new copy of the existing file request with all of the parameters from the original request. Enter a new name and description for the request (required), and a scheduled execution time (optional). 4. Edit parameters as needed. Refer to the Blank PDF Parameters and Data PDF Parameters sections in this manual for additional information.

5. Click Save to save the clone of the File Request. Request. return to the File Request page without saving.

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Deleting File Requests File Requests can be deleted in multiple ways; you can delete File Requests from directly within the request itself, or via the File Request page.

To Delete a Single File Request via the File Request Page: 1. Locate the desired file request by performing a File Request search. Refer to the Searching for PDF File Requests section for details. 2. Click the Delete icon Delete icon to the right of the desired PDF File Request.

3. The system displays a prompt to confirm the deletion. Click OK to continue and delete the File Request, or click Cancel to quit without deleting.

Note: File Requests can also be deleted from within the File Request parameters page. Click the Edit Pencil to view the parameters, and then click the Delete checkbox and link at the top of the paremeters page to delete the File Request.

PDF File Requests Requests with a status of “In Progress” may not be be deleted. Once the status changes, the PDF File Request may be deleted.

To Delete Multiple File Requests via the File Request Page: 1. Locate the desired file requests by performing a File Request search. Refer to the Searching for PDF File Requests section for details.



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2. Check the Select Checkboxes to the left of the File Requests that are to be deleted. Check the Delete Selected Selected checkbox and click the Delete Selected link. Selected link.

3. The system displays a prompt to confirm the deletion. Click OK to continue and delete the File Request, or click Cancel to quit without deleting.

Note: The Delete Selected checkbox remains grayed out unless PDF Files have been selected.

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Batch Scheduling PDF File Requests Existing PDF File Requests can be batch scheduled to generate multiple PDF files at a future date/time.

To Batch Schedule PDF File Requests: 1. Locate the desired file requests by performing a File Request search. Refer to the Searching for PDF File Requests section for details. 2. Check the Select Checkboxes to Checkboxes to the left of the File Requests that are to be batch scheduled.

3. Use the Batch Scheduling Date/Time controls to specify when the PDF Files should be generated. Refer to the Blank PDF Parameters Parameters and and Data PDF Parameters sections of this manual for details on using the date/time controls. Click Clear Clear to remove user-entered date/time selections.

4. Click Batch Schedule to Schedule to schedule schedule the job. The status of the selected selected File Requests is updated to “Scheduled”.

Note: The Batch Schedule checkbox remains grayed out unless PDF Files have been selected. Once the Batch Schedule button button is clicked, it returns returns to its grayed out state.



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Appendix A: Sample PDF Documents This section will cover the following topics: 

Sample Cover Page



Sample Blank PDF Document



Sample Data PDF Document



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Sample Cover Page PDF Cover Page and Bookmarks The figure below displays a PDF document with a cover page and the bookmark links. These settings were defined in the profile from the Configuration module.



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Sample Blank PDF Document Blank eCRF The figure below displays a Blank PDF document for a specific study and form. Header information and a header image are displayed at the top of the page. These settings are specified in the Document Properties section of the PDF Profile.

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Blank PDF Document with Annotations The figures below display a Blank PDF document that uses annotations. The first figure shows a blank PDF document that contains an annotation. Notice the number 1 to the right of the Date of Birth field. When you click this number, number, they are automatically directed to the Annotations page for this specific form.

The second figure is the annotations annotations page for the Date Date of Birth field. The details displayed are those specified in the Annotations page of the PDF Profile.



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Sample Data PDF Document eCRF With Data The figure below displays a Data PDF document document for a specific subject. The headers information and header image were specified on the Document Properties page of the PDF Profile. The field labels are clickable links that display the audit trail data for the specific field, as specified on the Audit Data page in the profile. The data dictionaries display not only the selected entries, but all entries in the dictionary, as specified in the Data Selection page in the profile.

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Audit Trail The figure below displays an Audit page for the Gender field on a Data PDF document. The header information and and header image are specified specified in the Document Properties page of the PDF Profile. The Field Label displayed in the header is a clickable link that returns you to the corresponding eCRF in the PDF document. The audit trail displays entries for those actions specified in the Audit Data page of the Profile.



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563 PDF Generator Final

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