For each clinical trial* regulated under the 2018 Common Rule and conducted or supported by a Federal department or agency, one IRB approved informed consent form used to enroll subjects must be posted to Clinicaltrials.gov or regulations.gov after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol 45CFR46.116(h).
*Clinical Trial is defined as 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.
TIPS:
• A consent must be posted for any study regulated by the 2018 Common Rule that is federally funded or FDA regulated.
• Posting the consent form is usually done by the sponsor or overall PI.