In 2016, National Institutes of Health (NIH) launched a multi-faceted effort to enhance its stewardship over clinical trials. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability.
NIH Definition of a Clinical Trial
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.
In alignment with this definition, a clinical study would be considered a clinical trial if the answer to the following four questions is yes:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
If the answers to the four questions above are yes, your study meets the NIH definition of a clinical trail, even if:
- You are studying healthy individuals
- Your study does not have a comparison group (e.g., placebo or control)
- Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
- Your study is utilizing a behavioral intervention
Studies involving only secondary research with biological specimens or health information, or studies that are intended solely to refine measures are not considered trials.
Some FDA-regulated studies are considered applicable clinical trials (ACT). In general these include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices.
All clinical investigators and clinical staff who are involved in the design, conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). The training is valid for 3 years and certificates of completion should be submitted with your IRB application.
If your research meets the definition of clinical research you will need to complete one of the following GCP training courses:
- GCP course for Clinical researchers and staff involved in the conduct of a clinical trial with human participants. This training course is free of charge and sponsored by the Clinical Trials Network. The course contains 12 self-paced modules and may take several hours to complete.
- GCP course for Social Behavioral researchers and staff involved in the conduct of a clinical trial with human participants. This online course is offered through the Office of Research Compliance Blackboard site. Please send an email to Researchcompliance@kent.edu requesting access. Be sure to include names and email addresses for all research personnel needing access to the course.
- GCP course for FDA-regulated studies - GCP training for researchers conducting clinical research with investigational drugs, biologics or devices should completed through the Collaborative Institutional Training Initiative (CITI). If you already have an account that is affiliated with Kent State, login and click on "Add a Course" from the My Learner Tools menu box. Choose the GCP course that best applies to your research. If you do not have a CITI account, you can find instructions for creating an account here.
Does your research need to be registered on ClinicalTrials.gov?
Requirements for registration with NIH as a clinical trial applies to:
- All NIH-funded trials such as phase 1 studies or clinical trials of behavioral interventions or non-FDA regulated products. This includes some social-behavioral research funded by the National Institutes of Health (NIH).
- Clinical trials involving FDA-regulated drug, biologic and device products.
- Studies intended for publication in a journal recognized by the International Committee of Medical Journal Editors (ICMJE). If you have questions about the need to register a specific study, you should err on the side of registration or consult the editorial office of the journal for which you wish to publish. Visit the ICMJE website for more information about their policy for registration of clinical trials.
Standard Operating Procedures
The Office of Research Compliance has prepared numerous Standard Operating Procedures (SOPs) for clinical research conducted at Kent State. In some cases, these SOPs may need to be modified and extrapolated to meet your specific project needs.