This policy establishes UCSF standards for Clinical Trial registration in order to comply with Food and Drug Administration (FDA) requirements and to secure the ability to publish clinical trial results under the International Committee of Medical Journal Editors (ICMJE) standards.
Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
The term used in the Food and Drug Administration Amendments Act (FDAAA) to designate interventional studies of drugs, biologics and devices for which information must be submitted to the Clinical Trial Registry Data Bank. An applicable drug clinical trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of FDAAA. An applicable device clinical trial is either: (1) a prospective clinical study of health outcomes comparing an intervention with a device subject to sections 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); or (2) a pediatric post market surveillance of a device as required under section 522 of the Food, Drug, and Cosmetic Act.
The term used in the Food and Drug Administration Amendments Act (FDAAA) to designate the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome of an applicable clinical trial, whether the clinical trial concluded according to the prespecified protocol or was terminated.
- Scope and Compliance
UCSF policy requires registration of all clinical trials (all phases and intervention types) before enrollment of the first subject in order to ensure compliance with ICMJE publication requirements. Failure to register prior to recruitment can result in inability to publish.
In order to comply with FDAAA, UCSF policy requires, for all ACTs initiated on or after 9/27/2007 and ongoing as of 12/26/2007: (1) registration in ClinicalTrials.gov, and (2) reporting of summary results in ClinicalTrials.gov. Failure to register and submit results within the required time frame can lead to civil monetary penalties and risk funding from federal agencies.
All investigator initiated clinical trials conducted at the University of California, San Francisco (UCSF) must be registered using the UCSF Institutional Account in the ClinicalTrials.Gov Protocol Registration System (https://register.clinicaltrials.gov). The UCSF institutional account name is: UCaliforniaSF.
The Committee on Human Research (CHR) has the final authority in deciding whether a protocol must be registered on ClinicalTrials.gov.
- Principal Investigator
For investigator initiated clinical trials, it is the responsibility of the Principal Investigator to:
- Register the clinical trial before the first subject is enrolled;
- Designate the Responsible Party in the PRS as either UCSF as the sponosor, or the PI him/herself if there is an FDA IND/IDE;
- Update ClinicalTrials.gov records at least once every 12 months (Recruitment Status and Primary Completion Date). It is recommended that the Record Verification Date be updated at least every 6 months, even if there were no changes to the record, for studies that are not yet completed.
- Close-out any studies before departing from UCSF, including ensuring that studies are properly closed or transferred to another investigator via the Committee on Human Research; and
- Submit summary results to ClinicalTrials.gov no later than 1 year after the Primary Completion Date (ACTs only).
- The Office of Ethics and Compliance is responsible for general oversight of ClinicalTrials.gov registration and enforcement of this policy.
- Submissions to ClinicalTrials.gov
- Updating protocol records on ClinicalTrials.gov
- Reporting Results on ClinicalTrials.gov
- UCSF Campus Code of Conduct
- U.S. Public Law 110-85, H.R. 3850, Food and Drug Administration Amendments Act of 2007 http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
- UCSF Clinical Research Resource HUB
- FDAMA Section 113 – Guidance for Industry “Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions”.
- International Committee of Medical Journal Editors (ICMJE) “Frequently Asked Questions about Clinical Trials Registration”
- U.S. National Library of Medicine/National Institutes of Health “FAQ: ClinicalTrials.gov Questions”
- National Institutes of Health Office of Extramural Research “FDAAA – Further Resources for NIH Grantees”
- “Elaboration of Definitions of Responsible Part and Applicable Clinical Trials” http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf