Training

Human Subjects (IRB) Training

Effective May 1, 2017, the expiration date for human subjects training was extended from 3 years to 5 years. (Please note: Any training completed prior to this date still has the 3-year expiration date.) We hope this change will alleviate some of the refresher training requirements and simplify the process for submitting IRB protocols.

All individuals engaged in human subjects research must complete this training at least every 5 years. Training options are offered online with CITI and myCourses, and live in-person trainings are available upon request.

IRB Online Training via myCourses

IRB Online Training via CITI

IRB Live Training Options

Check your training records

Good Clinical Practice (GCP) Training

NIH Clinical Trial Definition Change
Recently, NIH revised their definition of a clinical trial, which now is described as follows: "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.". There are 4 questions you can answer to help determine whether your study meets this new definition of a clinical trial, listed below.

Does my study qualify as a clinical trial?
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 you answer "yes" to all 4 questions, then your study meets the NIH definition of a clinical trial even if...

  • You are studying healthy participants
  • 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

What is NOT considered a clinical trial?

  • Studies that involve secondary research with biological specimens or health information are not clinical trials.
  • Studies intended solely to refine measures are not considered clinical trials.

What do I do if my NIH-funded study is considered a clinical trial?
As of January 1, 2017, all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials are required to be trained in Good Clinical Practice. While a particular course or program is not required, there are several options to obtain certification: NIH, NIAID, NIDA, NCATS, and CITI.

This training must be updated every 3 years. After you take GCP training, please send your completion certificate to the Office of Research Compliance so we can log your training records and update you as the 3 year expiration date draws near.

Resources
Clinical Trial Decision Tree https://grants.nih.gov/ct-decision/index.htm

Case Study Examples of Clinical Trials
https://nexus.od.nih.gov/all/2018/01/04/further-refining-case-studies-and-faqs-about-the-nih-definition-of-a-clinical-trial-in-response-to-your-questions/?utm_source=nexus&utm_medium=email&utm_content=nihupdate&utm_campaign=dec17

Good Clinical Practice Training https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm