Tip of the Week Archive

The Revised Common Rule (45 CFR 46) requires that an informed consent form must be posted on a public federal website (i.e., ClinicalTrials.gov) for any clinical trial conducted or supported by a federal department or agency (such as NIH).

Q: WHICH trials must post consent forms?
A: Clinical Trials, funded or conducted by a Common Rule department or agency, that were either IRB approved on or after January 21 2019 OR voluntarily transitioned to the Revised Common Rule requirements.

• Common Rule departments and agencies include our federal funders (such as NIH, VAORD, etc.)
• Clinical Trial means "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes."

Q: WHEN must the consent form be posted?
A: After recruitment closes, and no later than 60 days after the last study visit by any subject. 

Q: WHAT version of my consent form should I post?
A. Any version that was actually used to consent at least one subject.

• You do not need to update versions or post multiple versions of your consent form.
• NEVER post signed consent forms, or consent forms containing identifiable patient health information.

Q: WHO posts the consent form?
A: For investigator-initiated trials at CU, the Principal Investigator is responsible for posting the consent form. 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 ICF document to a PDF/A format, and then upload it to your ClinicalTrials.gov study record. 

• To convert a PDF document to a PDF/A, follow these instructions

For assistance, contact clinicalresearchsupportcenter@ucdenver.edu. We are always happy to help you with your ClinicalTrials.gov questions.