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. |
|
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. |
|
Blank Forms Only | Generate this type to view blank forms with active controls for a study version. |
|
Custom PDF | This type gives users access to all settings, letting them control what to include in the output. |
|
Custom Blank Forms | Like the Custom PDF, the user can access all available settings, but the output only includes blank forms with active controls. |
|
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.