135. Clinical Trial Requirements
Updated May 26, 2021
Clinical trials must comply with a variety of requirements that do not apply to other types of human research. These requirements are designed to address the increased participant vulnerability and risks of many clinical trials compared with other research. They are also meant to ensure meaningful results. Below are some of the major requirements that apply to clinical trials.
Consent Form Posting Requirement
Under the revised human research protection regulations (known as the revised “Common Rule”) that took effect on January 21, 2019, one IRB-approved consent form used to enroll participants 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 at 45 CFR 46.102(b) 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 above definition of clinical trial must comply with the posting requirement. 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 participants, as required by the protocol. If the federal department or agency supporting or conducting the clinical trial determines certain information should not be made publicly available on a federal website (e.g., confidential commercial information), the federal department or agency may permit or require redactions to the information posted.
Registration and Reporting of Clinical Trial Results
ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. The purpose of ClinicalTrials.gov is to disclose to the public key information about clinical trials that are currently available or previously conducted. ClinicalTrials.gov captures summary protocol information before and during the trial as well as summary results and adverse event information of a completed trial. Federal laws, regulations and editors of prominent medical journals require registration of a clinical trial, as described below.
A University or Affiliate investigator who conducts a clinical trial must comply with these requirements if:
- She or he is the Principal Investigator (PI), AND
- The study is investigator-initiated (the clinical trial is not an industry trial in which the protocol is developed, owned, and sponsored by a company. Industry sponsors are responsible for registering their trials.)
Food and Drug Administration (FDA) requirements
Registration is required for studies that meet the definition of an “applicable clinical trial” (ACT) and either were initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. Studies must be registered no later than 21 days after enrollment of the first participant. The holder of any IND, IDE, or HDE from the FDA must ensure compliance with these requirements.
National Institutes of Health (NIH) requirements
Regardless of study phase or type of intervention, all NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the “NIH Policy on Dissemination of NIH-Funded Clinical Trial Information” for competing applications and contract proposals submitted on or after January 18, 2017. The primary awardee must ensure compliance. Studies must be registered no later than 21 days after enrollment of the first participant. The primary NIH grant awardee must ensure compliance with these requirements.
International Committee of Medical Journal Editors (ICMJE)
For studies that plan to publish within medical journals, ICMJE requires registration of clinical trials. Studies must be registered at or before the time of first participant enrollment
All investigator-initiated clinical trials that fall into one or more of the above categories must register on ClinicalTrials.gov to comply with federal FDA requirements outlined in FDA 42 CFR 11 (Final Rule) and/or other federal agencies and department’s policy or requirements. Studies that fall under multiple registration requirements only need to be registered once. The information posted on ClinicalTrials.gov must be updated throughout the course of the trial, verified at least every 12 months, and the results must be provided when the study ends.
Note: Even if an investigator-initiated clinical trial does not meet the NIH or FDA clinical trials registration requirements, researchers are strongly advised to read and consider registering your trial to comply with the additional requirements of the International Committee of Medical Journal Editors (ICMJE) for publications purposes and of other research funders now requiring registration and results reporting.
In the case of multi-site clinical trials, the lead PI for the entire study is the individual responsible for complying with the requirements. If the University or Affiliate investigator is the PI solely for the local site and is not the primary awardee or lead study PI, then the University or Affiliate PI is not responsible for posting to ClinicalTrials.gov.
For more detailed guidance regarding clinical trials requirements, please visit the information page entitled, Clinical Trials Information Registration and Results Reporting Requirements available on the Research Integrity website.