Tip of the Week Archive

Requirements for Submitting the Protocol and Statistical Analysis Plan to ClinicalTrials.gov

The regulations at 42 CFR 11.48(a)(5) require a copy of the protocol and Statistical Analysis Plan (SAP) (if not included in the protocol) to be submitted with clinical trial results information for any Applicable Clinical Trial (ACT) with a Primary Completion Date on or after January 18, 2017.

The regulations permit the responsible party to "redact names, addresses, and other personally identifiable information, as well as any trade secret and/or confidential commercial information*…unless such information is otherwise required”.

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.

The protocol and SAP (if not included in the protocol) should be uploaded in the Document Section of the ClinicalTrials.gov record.

*As those terms are defined in the Freedom of Information Act (5 U.S.C. 552) and the Trade Secrets Act (18U.S.C. 1905)