Clinical Trial Registration
What Studies to Register?
Effective 01/18/2017, the following clinical trials must be registered on http://www.clinicaltrials.gov:
|Reporting Requirements||ICMJE Policy
|FDAAA Final Rule
(Results Reporting Required)
|Final NIH Policy
(Results Reporting Required)
|Phase||All||Not Phase 1 (feasibility)||All|
Drugs, Biologics & Devices regulated by FDA
All (including any behavioral or any study where the purpose is to modify one or more health-related biomedical or behavioral outcomes)
Examples include, but are not limited to: drugs/small molecules/compounds/; biologics; devices; procedures (e.g. surgical techniques); delivery systems (e.g. telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g. diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and diagnostic strategies.
|Enforcement||Refusal to publish||Civil proceedings and civil penalties (up to $10,000/day);
Loss of HHS funding
|LOSS OF NIH FUNDING FOR INVESTIGATOR AND INSTITUTION|
|Responsible parties will be required to correct or address within 15 days for registration information and within 25 days for results information, any apparent errors, deficiencies and/or inconsistencies that are identified during the National Library of Medicine (NLM) quality control review process. See 42 CFR 11.64 (b). Responsible parties will also be required to correct or address any errors that they identify on their own, including after quality review by NLM is complete.|
ACRP training (preferred) or CITI or NIH or equivalent training (with provision of certification)
|Basic Biomedical Science to include Ethics and Human Subject Protection||- Basic Biomedical Science to include Ethics and Human Subject Protection
- Good Clinical Practice required for IND/IDE holders
|- Basic Biomedical Science to include Ethics and Human Subject Protection
- Good Clinical Practice for all study personnel for all NIH funded Clinical Trials
The Health Science Center Principal Investigator of any investigator-initiated probable applicable clinical trial (pACT)), regardless of funding source, is responsible for registering the trial, maintaining the registration until trial completion, and reporting of results (i.e. they are the Responsible Party).
Helpful information on registration can be found on the ClinicalTrials.gov site at https://clinicaltrials.gov/ct2/manage-recs/how-register.
Contact the OCR office at OCRmail@uthscsa.edu or 567-8555 to request PRS user accounts for registration of studies or if you have any questions or concerns related to ClinicalTrials.gov registration and reporting requirements.
- Summary of Final Rule changes:
- Applicable Clinical Trial Checklist (FDAAA): https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
- Submit studies: https://clinicaltrials.gov/ct2/manage-recs
- Submission of Results and Frequency of Updates: https://clinicaltrials.gov/ct2/manage-recs/how-report
- Federal Register: Clinical Trials Registration and Results Information Submission: https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
- Tutorials for using ClincalTrials.gov: https://www.nlm.nih.gov/bsd/viewlet/ct/
- NIH News Release: https://www.nih.gov/news-events/news-releases/hhs-takes-steps-provide-more-information-about-clinical-trials-public