1 Summary
2 Compatibility
- 2.1 Standards
- 2.2 Industry Guidance
- 2.3 Recent Changes
3 Configuration Requirements
- 3.1 Global Setting
4 Details
- 4.1 Available Settings
5 Other Output Drivers
- 5.1 Visit Names and Order
6 User Interface
7 Limitations / Restrictions

Summary

We are trying something new. This format and presentation of information in this article is experimental. We intended to help users get the best from our standard reports / exports and dashboard components. What we include and how we present it may change over time. We welcome feedback on this article and contents via our service desk portal.

The FDA expects pharmaceutical companies to provide the completed Case Report Forms (CRFs) as part of the electronic FDA submission package. The ClinSpark Completed CRF provides customers with CRFs that comply with the FDA’s requirements for PDF documents.

View Script	6f65487c8e25f70d91f81161f4076e80
Data Script	b9d368214f8600592f61d2efd26c6316
Data Script Template	dedba6712b1caacb999d279af5beeae1

	Commit	Date

	Commit	Date
Merged	8df14a	Aug 31, 2023

Compatibility

Standards

The following standards have been followed:

https://www.fda.gov/media/76797/download

Industry Guidance

The following industry guidance has been followed where possible and appropriate:

Recent Changes

Key changes. May not include minor changes.

Fonts updated to be in the 9-12 points range.
Margin at least 3/4" of left and 3/8" on other sides but header/footer should not appear within 3/8”.
For landscape orientation, the margin of 3/4" at the top allows a more legible display of information.
Study Events have been renamed as Visits.
Dates follow the pattern ddMMMyyyy HH:mm:ss and are consistent with the web application.
Added a Form based Table of Contents.
Title of the document is now "crf-[study number]-[site number]-[subject identifier]” in lower case.
The subject is now identified by one selected identifier across the cover page and subsequent pages. Lead-in numbers are not displayed by default.
The filename is configurable and defaults to screening number.
Inherit Zoom is supported across all properly bookmarked PDFs.
The default Visits Table of Contents can be configured not to display.
In the case of multiple AEs, bookmarks can be set to point only to the first AE.
Where available, timepoints are added to the Visits bookmarks.
Bookmarks are collapsed by default.
Subject Over Volunteering page can be set not to display.
Visits are displayed in the PDF in the order they are displayed in the user interface.

Configuration Requirements

The behavior of the Completed CRF report can be adjusted through system level configuration options available to IQVIA support staff.

Global Setting

System level configuration is through the use of a Global Setting with a key of CompletedCRFReportSettings. The setting value is in "JSON" format.

The use of configuration is perhaps best illustrated through examples. Firstly, consider a Global Setting value that configures the Sample CRF Report to hide the ‘code lists’ section:

{
"includeScreeningNumber":  true,
"includeLeadInNumber": false,
"filenameIncludesScreeningNumber": true,
"filenameIncludesLeadInNumber": false,
"filenameIncludesRandomizationNumber": false,
"displayVisitToc": true,
"displayFormToc": true,
"includeOverVolunteeringForm": false,
"onlyDisplayFirstAePerVisit": false
}

Details

Available Settings

The available settings are as shown in the following table.

Setting Name	Description	Possible values	Default

Setting Name	Description	Possible values	Default
`includeScreeningNumber`	Controls visibility of the Screening Number in the PDF	`true` or `false`	`true`
`includeLeadInNumber`	Controls visibility of the Lead in Number in the PDF	`true` or `false`	`false`
`filenameIncludesScreeningNumber`	Controls whether screening number is used in the filename	`true` or `false`	`true`
`filenameIncludesLeadInNumber`	Controls whether lead in number is used in the filename	`true` or `false`	`false`
`filenameIncludesRandomizationNumber`	Controls whether randomization number is used in the filename	`true` or `false`	`false`
`displayVisitToc`	Controls whether a Table of Content is displayed for Visits	`true` or `false`	`true`
`displayFormToc`	Controls whether a Table of Content is displayed for Forms	`true` or `false`	`true`
`includeOverVolunteeringForm`	Controls whether OverVolunteering forms are displayed	`true` or `false`	`false`
`onlyDisplayFirstAePerVisit`	Controls linking behaviour for Adverse Events	`true` or `false`	`false`

Other Output Drivers

Visit Names and Order

This is dictated by the names and sequence of Study Events in the Study Library…

Remember that Study Events can be dragged and dropped in the UI…

User Interface

The report can be accessed via the Study | Report menu once a study has been selected…

The report includes the ability to:

Include Non-CRF data
Include non-randomised subjects
Exclude Data Audit Trails
Exclude Review (signing, non-signing) information
Filter to given subjects
Display Item Names

Limitations / Restrictions

This report is expected to pass validation using https://www.lorenz.cc/Solutions/eValidator-BASIC/. Exceptions are listed below.

ClinSpark currently does not support a way to apply the ‘fast web view’ setting to PDFs.
1. You can edit PDFs in Acrobat Pro to set the ‘fast web view' option may be able to achieve this in bulk by using one of Adobe’s ‘actions’. See https://helpx.adobe.com/ie/acrobat/using/optimizing-pdfs-acrobat-pro.html
Depending on the viewer used to open the PDF output, bookmarks may be expanded when the document is first opened. Some viewers correctly present the bookmarks as closed.
ClinSpark has no direct way to set the ‘inherit zoom’ property of the PDF output, but we believe that this works under typical conditions.