Different laws, regulations, policies, and academic journals have different requirements for a study that meets their definition of a clinical trial. Please see below to learn more about what is required under these various definitions.
FDA Requirements
The FDA requires the following regarding clinical trial registration, maintenance, and results reporting:
- Applicable drug and device clinical trials are required to be registered on clinicaltrials.gov within 21 days after the first subjects has been enrolled (with few exceptions).
- Applicable drug and device clinical trials are required to be updated at least once every 12 months.
- Applicable drug and device clinical trials are required to post results no later than one year after the clinical trial completion date (with few exceptions).
To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.
ICMJE Requirements
Different medical journals that are members of the ICMJE working group require prospective registration of all interventional clinical studies, but does not require results reporting for registered trials. IMCJE allows registration on several different clinical trial databases, including clincaltrials.gov. More information can be found on the ICMJE website.
Note: Currently, as these requirements are not required by Federal law, regulation, or policy, the Office of Regulatory Affairs and Clinical Trials is not responsible for registering these trials. However, the Office of Regulatory Affairs and Clinical Trials will provide support as needed.
To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.
OHRP Requirements
The Office of Human Research Protections requires all clinical trials as defined in the Common Rule (45 CFR 46.102(b)) must post a consent form that was used in the trial. Only one consent form needs to be posted and revised versions do not need to be uploaded. The consent form should only be posted if the actual document had been used to enroll a subject (signed consent forms should not be posted).
Furthermore, the timeline for when the consent form should be posted is between the date that recruitment was closed and 60 days after the last study visit by an enrolled subject as required by the protocol. If the consent form is posted after 60 days after the last study visit, or before recruitment is closed, then the federal requirement to post the consent form is considered unmet.
To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.
NIH Requirements
NIH requires the following regarding clinical trial registration, maintenance, and results reporting:
- Clinical trials are required to be registered on clinicaltrials.gov within 21 days after the first subjects has been enrolled (with few exceptions).
- Clinical trials are required to be updated at least once every 12 months.
- Clinical trials are required to post results no later than one year after the clinical trial completion date (with few exceptions).
To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.