Clinical Trial Requirements
Clinical trials must comply with many requirements that do not apply to other types of human subjects 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 we describe some of the major requirements that apply to clinical trials.
Does the revised Common Rule affect my research?
Consent Form Posting Requirement
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. Twenty federal agencies and departments, including HHS, have adopted the Common Rule – for a complete list of federal agencies and departments that have adopted the Common Rule, see https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.
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. 45 CFR 46.102(b).
Social, behavioral, and educational research studies funded by a Common Rule department or agency and that fit the definition of clinical trial in 45 CFR 46.102(b) must also comply with the posting requirement.
To further understand how the clinical trial definition applies to your research, you may find the NIH website for Definitions of Clinical Trials Case Studies helpful. The website gives examples of studies that are considered a clinical trial and those that are not.
Good Clinical Practice Training
Per NIH Policy, all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP).
Additional guidance on GCP training requirements can be found at: https://www.nucats.northwestern.edu/research-resources/clinical-research-infrastructure/index.html
What is ClinicalTrials.gov?
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.
How do I determine if I must comply?
A Northwestern University 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.)
What kind of studies need to be posted on ClinicalTrials.gov and when?
See the table below for a summary of ClinicalTrials.gov registration requirements:
|
Required by: |
Types of studies: |
When to register by: |
|
Food and Drug Administration |
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. FDA definition of an ACT |
Must register no later than 21 days after enrollment of the first participant |
|
National Institutes of Health |
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. NIH definition of a clinical trial |
Must register no later than 21 days after enrollment of the first participant |
|
International Committee of Medical Journal Editors |
For studies that plan to publish within medical journals, ICMJE requires registration of clinical trials. ICMJE definition of a clinical trial |
Must register at or before the time of first participant enrollment |
All investigator-initiated clinical trials 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.
Important note: Even if your investigator-initiated clinical trial does not meet the NIH or FDA clinical trials registration requirements, you are strongly advised to read and consider registering your trial to comply with the following additional requirements:
- International Committee of Medical Journal Editors (ICMJE) for publications purposes
- Center for Medicare & Medicaid for research billing claims for qualifying clinical trials
- Research funders now requiring registration and results reporting
What else should I consider?
Multi-site clinical trials:
The lead PI for the entire study is the individual responsible for complying with the requirements. If the NU investigator is the PI solely for the NU site and is not the primary awardee or lead study PI, then the NU PI is not responsible for posting to ClinicalTrials.gov.
IND, IDE, HDE trials:
The holder of any IND, IDE, or HDE from the FDA must ensure compliance.
NIH funded trial:
The primary awardee must ensure compliance.
Who can help me with registration and other questions?
Questions can be directed to clinicaltrials.gov@northwestern.edu. Support for ClinicalTrials.gov is conducted through the Northwestern Clinical and Translational Science Institute (NUCATS). Please find additional information here.