» Clinical Trials

Identifying and Managing Compliance for Clinical Trials Involving Research with Human Subjects

The following information is intended to assist Chapman researchers in determining when their research could be considered a “Clinical Trial”, communicate special responsibilities that principal investigators (PIs) must fulfill for some clinical trials, and provide guidance on how PIs can meet these regulatory obligations.

An expanded definition: What is a “clinical trial”?

The  U.S. National Institutes of Health (NIH) defines a clinical trial 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 those interventions on health-related biomedical or behavioral outcomes.” 

A simple test to determine if the activity is a clinical trial is to answer the following questions:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

*If the answer is ‘yes’ to all questions then the study is a clinical trial as defined by the NIH.

Note: Studies intended solely to refine measures, or studies designed to assess the nature or quality of a measurement, as opposed to the effect of an intervention on a biomedical outcome are not considered clinical trials.

See the Decision Tree for NIH Clinical Trial Definition .

The expanded definition includes a broad characterization of an “intervention” as any manipulation of the subject or their environment. It also broadly defines “outcomes” as any goal or condition in which the effect of the intervention is realized.

This definition must be considered in connection with a long list of case studies issued by NIH (and which they continue to revise) that add nuance. The NIH website includes case studies, FAQs, and a decision tool to help researchers understand the new definition.

FDA regulated Clinical Trials (Federal/non-federal/investigator-initiated)

The US Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, diagnostics, and in some cases dietary supplements and food additives. All such research studies must be conducted in accordance with FDA requirements for the protection of human subjects and IRBs, regardless of source of funding (21 CFR Parts 50 and 56).

“Clinical Trials subject to FDA regulation, mean that the trial is typically conducted under an investigational new drug application (IND) or investigational device exemption (IDE).

Chapman’s Cayuse IRB application form contains prompts to assist the PI in determining whether a study might be a clinical trial, and the IRB approval letter will specify that a study is a clinical trial if the IRB makes the determination. 

What do I need to do if my study is a clinical trial?

If your study is a clinical trial (as defined above), the PI is ultimately responsible for complying with applicable obligations, as summarized below:

  • PI Responsibilities: All PIs are expected to complete following and understand the responsibilities for conducting clinical trials at Chapman. These are provided in the PI Responibilities for Conducting Clinical Trials at Chapman guidance.
  • Data Safety Monitoring Plan: The IRB requires the PI to have a Data and Safety Monitoring Plan in place that protects the safety of subjects, the validity of the data, and the integrity of the research study. The IRB reviews the plan and determines if the plan has adequate provisions in place for monitoring the data collected to ensure the safety of participants. Investigators should use the Guidance for Data Safety Monitoring Plan.
  • Training in Good Clinical Practices (GCP): Researchers involved in the design, conduct, oversight, or management of a clinical trial must be trained in GCP.  A condition of protocol approval, the Chapman IRB will require evidence that all study personnel listed on the protocol have completed GCP training within the last 3 years. Note that this training is in addition to basic IRB human subjects training required for researchers on expedited and full board review studies.  PIs should also be aware of the requirements that the IRB or study sponsor will use to monitor the activities depending on the type of study as follows 
  • Registration and reporting on ClinicalTrials.gov: Registering and reporting your clinical trial is required for all federally sponsored clinical trials or non-federally sponsored (industry/investigator-initiated) clinical trials that involve an investigational drug or device (e.g. test article). The ClinicalTrials.gov Registration User's Guide provides step by step guide to registering the clinical trial.