Requirements for Posting the Protocol and Statistical Analysis Plan to ClinicalTrials.govJun 23, 2022
The study Protocol and Statistical Analysis Plan (SAP) (often included in the protocol) must be posted to ClinicalTrials.gov along with basic results information for certain clinical trials.
Q: WHICH trials must post the Protocol and SAP?
A: Studies required to have the Protocol and SAP posted as part of results reporting include:
- Applicable Clinical Trials (ACTs) with a Primary Completion Date on or after January 18, 2017.
- NIH-funded clinical trials (including behavioral, phase 1, and early device feasibility interventions) for which the study started and the grant application was submitted to NIH on or after January 18th, 2017.
Q: WHEN must the Protocol and SAP be posted?
A: At the time of results reporting, no later than 12 months after the Primary Completion Date.
- The Primary Completion Date is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. Usually, the last participant's last study visit.
- To protect your research and ensure that the correct version is posted, do not post the Protocol or SAP before reporting results.
Q: WHAT version of my Protocol and SAP should I post, and what do they need to include?
A. Post the most recent IRB approved version at the time of results reporting.
- They can be the same document: the SAP is often included in the protocol.
- Documents must include the Official Title of the study, NCT number (if available), and version date on the first page.
- You may redact personally identifiable information (e.g., names, addresses), as well as trade secret and confidential commercial information.
- The SAP should include: how data are analyzed; what specific statistical methods are used for each analysis, and how adjustments are made for testing multiple variables. If some analysis methods require critical assumptions, the written description should allow data users to understand how those assumptions were verified.
Q: WHO posts the Protocol and SAP?
A: For investigator-initiated trials at CU, the Principal Investigator is responsible for posting the Protocol and SAP. This can be delegated to study team members with access to the ClinicalTrials.gov record.
Q: HOW do I post a consent form to my ClinicalTrials.gov record?
A: You will need to convert your document(s) to a PDF/A format, and then upload it to your ClinicalTrials.gov study record.
For assistance, contact email@example.com. We are always happy to help you with your ClinicalTrials.gov questions.