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.
Do I need to register the trial and what is the timeline to do so?
If your study falls under the definition of an Applicable Clinical Trial per FDAAA 801 or is considered a clinical trial per NIH's Final Rule, you are required to register within 21 days after the first subject has been enrolled (with few exceptions).
If your clinical trial meets the criteria for IMCJE, PCORI, or WHO, then you are required to register prior to any enrollment.
If your clinical trial is funded by ORD in the VA, then you must register and the timeline to do so is deferred to either FDAAA 801 or ICMJE, depending on which scenario applies.
If you intend to submit claims to the Center for Medicaid and Medicare Services (CMS), then you are must register prior to any enrollment.
Note: OHRP does not require enrollment for trials that only meet their definition.
Please see our Definitions Page for more guidance. To learn more about how to register, maintain, upload documents or submit results in ClinicalTrials.gov, please see our Clinical Trials Procedures Page.
Do I need to update the record and what is the timeline to do so?
All clinical trials that require registration must be updated on at least an annual basis (also known as "Annual Verification"). Additionally, changes to the overall recruitment status, recruitment status at any study site, and the last follow-up date for the primary outcome measure (e.g., primary completion date) must be made within 30 days of the change. Other changes or updates to the record, such as protocol amendments, must be made at least every 12 months.
Please see our Definitions Page for more guidance. To learn more about how to register, maintain, upload documents or submit results in ClinicalTrials.gov, please see our Clinical Trials Procedures Page.
Do I need to upload consent forms and what is the timeline to do so?
All clinical trials, other than those defined by ICMJE, are required to post the consent form in ClinicalTrials.gov after the trial is closed to recruitment and no later than 60 days after the last study visit.
Note: As OHRP does not require registration of clinical trials, a dedicated website has been established to upload the consent forms for for these trials.
Please see our Definitions Page for more guidance. To learn more about how to register, maintain, upload documents or submit results in ClinicalTrials.gov, please see our Clinical Trials Procedures Page.
Do I need to post results and what is the timeline to do so?
All clinical trials, other than those defined by ICMJE and OHRP, are required to post results in ClinicalTrials.gov within 12 months after the last study visit. This requirement relates to when the results have been approved by the PRS review process and are made public. This does not refer to when results are submitted for review in the ClinicalTrials.gov system. Please plan accordingly as the review process can sometimes take up to several months.
Note: ICMJE and OHRP do not require the posting of results.
Please see our Definitions Page for more guidance. To learn more about how to register, maintain, upload documents or submit results in ClinicalTrials.gov, please see our Clinical Trials Procedures Page.