Investigators engaged in clinical trials research will now be required to upload their protocols and Statistical Analysis Plans (SAPs) to ClinicalTrials.gov when reporting results. As a reminder, the VCU ClinicalTrials.gov Program offers guidance regarding definitions, timelines, registration and reporting obligations, resources, and any other questions related to ClinicalTrials.gov.
This federal regulation applies to investigator-initiated FDA-regulated Applicable Clinical Trials (ACTs) and NIH-funded clinical trials. The newly revised ACT Checklist and FAQs are also accessible from the Final Rule Information page. A link to this checklist is also being added to the VCU Clinical Research Compliance Program page.
The Final Rule Information (excerpted): June 29, 2017 – The operational PRS will be updated to accommodate protocol and statistical analysis plan (SAP) document submission as described in 42 CFR 11.48(a)(5). These changes can be previewed on the PRS Test System starting on June 16, 2017. To submit the protocol and SAP as part of results information for a study with a Primary Completion Date on or after January 18, 2017, but before June 29, 2017, email firstname.lastname@example.org for assistance.
- Protocol and SAP documents will need to be submitted in the Portable Document Format Archival (PDF/A). PDF/A is a format adopted in ISO 19005 and additional background on this format is available from the Library of Congress: PDF/A, PDF for Long-term Preservation. It is strongly encouraged that the PDF/A file also be consistent with the PDF Universal Accessibility (PDF/UA). After responsible parties upload these documents into the PRS, the files will be verified as PDF/A format. There will not be support in the XML upload or the PRS API for submitting these documents.
- Note: This mechanism for submitting protocols and SAPs will also accommodate the optional submission of informed consent documents formatted as PDF/A. Although not required by 42 CFR Part 11, the preamble to the Final Rule indicated that ClinicalTrials.gov would accept the final version of the informed consent document for posting. (81 FR 64999)
-This post includes content previously made available via the VCU Wright Center ClinicalTrials.Gov Program