Archive types and the files and subject data included

Here's what's included with the output of each archive request

Each request produces a zip file that includes the following.

Table 1-1 Archive request output details

Request type	Description	Included in the .zip file
Submission PDF	Generate this type for submission to the FDA and other regulatory agencies at the conclusion of a study. The information is automatically compiled and formatted according to the regulators' requirements.	One folder per site, each containing one PDF per subject. Table of Contents Request Settings Blank forms with active controls for each study version. Protocol Guide Study Design Note: The zip file includes the protocol guide and study design only if the study administrator made them available on the Documents tab on the study’s home page. The Visit Calculator and Sample Book are not included. For more information, see What types of study documentation are there?.
Archival PDF	Generate this type for mid-study data analysis or to generate a final archive of study data, which can then be made available to auditors, sponsors, sites, and regulatory agencies.	One folder per site, each containing one PDF per subject. Table of Contents Request Settings Blank forms with active controls for each study version.
Blank Forms Only	Generate this type to view blank forms with active controls for a study version.	Request Settings Blank forms with active controls for each study version.
Custom PDF	This type gives users access to all settings, letting them control what to include in the output.	One folder per site, each containing one PDF per subject. Table of Contents Request Settings Protocol Guide Note: The zip file includes the protocol guide only if the study administrator made it available on the Documents tab on the study’s home page and the Request Setting, Protocol Guide, is set to Yes.
Custom Blank Forms	Like the Custom PDF, the user can access all available settings, but the output only includes blank forms with active controls.	Request Settings Blank forms with active controls for each study version.

What subject data gets included in archive requests and history reports

The PDF layout does not differ between request types; only the data included in the output does.

• For archive requests that include subject data (Submission, Archival, and Custom), Oracle InForm CRF Submit provides a PDF that reflects each subject's casebook and includes item, query, form, and visit details, audit trail information, and details for comments and signatures.
• Oracle InForm CRF Submit relies on the Oracle InForm rights groups to determine what data to include in the archive request and history report output. If a user assigned to a rights group can't see specific information in the study, the output reflects that.
• The data included in the output gets determined by the selection from the Select the rights group to control content setting. This setting is only available for sponsor users on the Archival PDF and Custom PDF request types and for the Audit Trail Report.

  Note:

  The setting defaults to the rights group of the user generating the request.