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 also are meant to ensure meaningful results. Some of the major requirements that apply to clinical trials are described below.
 

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 DHHS, 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 that fit the definition of clinical trial in 45 CFR 46.102(b) must also comply with the posting requirement.
 

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).

While FDA regulation do not specifically address GCP training, LSUHSC-NO (LSUNO) HRPP policies require GCP training for all investigators participating in studies involving FDA-regulated drugs, biologics and devices. Sometimes sponsors of such studies also require GCP training.

LSUNO investigators can meet the GCP training requirement by completing the relevant basic and refresher GCP courses at CITI Program. CITI GCP courses are tailored to different types of clinical research including:

  • Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
     
  • Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
     
  • Clinical Investigations of Devices
     
  • Social and Behavioral Research Best Practices for Clinical Research

Instructions for LSUNO investigators to log in to CITI are available here.

Please note that the CITI Human Subjects Protections course does not fulfill the GCP training requirement.
 

Registration and Reporting of Clinical Trial Results

What is ClinicalTrials.gov?

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 were 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.
 

Do you need to comply with this requirement?

An LSUHSC-NO 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:

FDA

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

NIH

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

ICMJE

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.

Additional details about FDA and NIH requirements are available here.

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 you consider?

Multi-site clinical trials:
The lead PI for the entire study is the individual responsible for complying with the requirements. If the LSUNO investigator is the PI solely for the LSUNO site and is not the primary awardee or lead study PI, then the LSUNO 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 trials:
The primary awardee must ensure compliance.
 

Who can help you with registration and other questions?

  • Registration instructions for LSUNO investigators is available here.
     
  • Questions should be directed to the IRB Office at IRBOffice@lsuhsc.edu