Available archive types and reports

Learn more about each archive type, report, and its settings.

• Submission PDF
  Users assigned to a sponsor study role typically use this archive 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 (for sponsor users)
  Users assigned to a sponsor study role typically use this archive type for mid-study data analysis or to generate a final archive of study data. This makes the data available for auditors, sponsors, sites, and regulatory agencies.
• Archival PDF (for site users)
  Users assigned to a site study role typically use this archive type for mid-study data analysis or to generate a final archive of study data. This makes the data available for auditors, sponsors, sites, and regulatory agencies.
• Blank Form PDF
  Generate this type of archive to view a set of blank forms with active controls for each study version. The output contains no subject data.
• Custom PDF
  This archive type gives users assigned to a sponsor study role access to all of the settings available in Oracle CRF Submit, letting them control what to include in the output.
• Kit Chain of Custody (Blinded) report
  Some organizations require the sponsor and sites to archive the Kit Chain of Custody (Blinded) report. Still, not all organizations grant site access to the standard report, located under the Reports tab, and the standard report cannot be shared with sites.
• Download Log report
  Users assigned to a sponsor study role can generate this report (CSV only) to view a history of all archive downloads performed by sponsor and site users in the Oracle Clinical One Platform user interface.
• Site Confirmation report (for site and sponsor users)
  Sponsor and site users can generate this report (CSV or PDF) to view an audit history of confirmation actions performed by site users.