Compliance & Integrity
Clinical Trials and Related Requirements
Clinical trials must be placed in a public database, ClinicalTrials.gov, as mandated by federal agencies. The trials are required to be registered when they begin and updated throughout the life of the study. Additionally, study results must be provided upon completion of the study. Monetary penalties can be applied by the agencies if the requirements are not met.
The responsible party is considered to the study sponsor (i.e, IND or IDE holder or the initiator of the study) or a sponsor-designated PI who is responsible for conducting the study and has access to and control over the clinical data to analyze the data and publish the results.
The PI should consult with industry sponsor to assure that posting of a trial is in accordance with terms of the study contract. A sponsor whom provides study drug only typically does not accept the registration/results reporting responsibilities.
All UNCG investigators and staff who are involved in the design, conduct, oversight or management of clinical trials must be trained in Good Clinical Practice (GCP).
ClinicalTrials.gov Registration Guide
- Initial Registration: No later than 21 days after enrollment of first subject
- Interim updates: The record must be updated annually (even if nothing has changed) until the final results are reported. NOTE: Specific type of changes must be reported within 30 days.
- Reporting Results: No later than one year after the trial’s primary completion date. This is the date when the final subject was examined or received an intervention for the purposes of collection of data for primary outcomes.
Specific information on the data elements required by FDA and NIH for registration reporting is located on the ClinicalTrials.gov Protocol Registration System information website.
Data elements for protocol registration
Data elements for results reporting
The PI can delegate the responsibility for entering information for purposes of registration, updates and reporting of results, however, the PI remains responsible for:
- The accuracy of the information
- The Approve and Release actions which are required every time information is entered into the record
Failure to register or provide incomplete/false information (including updates subsequent to initial registration) may include monetary penalties of up to $10,000 per incident and/or per day, non-compliance notification from the FDA, and for federal sponsored studies, the withholding or recovery of grant funding.
NIH grantees are required to certify compliance with registration/reporting requirements in grant applications and progress reports.
| Required By | Studies | When |
| National Institutes of Health (NIH) | Registration is required for studies that meet the definition of an “applicable clinical trial” (ACT). | Must register no later than 21 days after enrollment of the first participant |
| Food and Drug Administration (FDA) | For studies that plan to publish within medical journals, ICMJE requires registration of clinical trials. ICMJE requires, and recommends that all medical journal editors require registration of clinical trials in a public trials registry at or before the time of first participant enrollment as a condition of consideration for publication. | Must register no later than 21 days after enrollment of the first participant |
| International Committee of Medical Journal Editors (ICMJE) | For studies that plan to publish within medical journals, ICMJE requires registration of clinical trials. ICMJE requires, and recommends that all medical journal editors require registration of clinical trials in a public trials registry at or before the time of first participant enrollment as a condition of consideration for publication. | Must register at or before the time of first participant enrollment |
Under the revised human subjects protection regulations (known as the revised “Common Rule”) that took effect on January 21, 2019, one IRB approved consent form must be posted on a publicly-available federal website for each clinical trial funded by any federal agency or department that has adopted the Common Rule.
For purposes of this consent form posting requirement, a “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.
Social, behavioral, and educational research studies funded by a Common Rule department or agency and that fit the definition of clinical trial must also comply with the posting requirement.
Who is Responsible for Posting
The posting requirement is the responsibility of the awardee. If UNCG is the only awardee, the UNCG PI bears the responsibility for meeting this requirement. For multi-site studies the prime awardee is the responsible party.
When must it be posted?
The informed consent form must be posted on the federal website 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.
For studies that are registered on ClinicalTrials.gov, the informed consent form should be uploaded at the same time the Overall Status is updated to reflect the trial is closed to recruitment.
What consent version?
The most recent IRB approved version of the consent form that has been used to enroll a participant should be posted.