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 live in-person trainings are available upon request for groups of 10 or more.
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?
- 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 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. This training must be updated every 3 years.
GCP training is available in myCourses. To Self Enroll:
- Go to my.msstate.edu
- Click on the menu button (Triple bar) and go to the Classroom tab
- Click the drop down for Select a course... under Canvas Course Self Enrollment
- Select the course you want to enroll in
- Click the Confirm Enrollment slider to select Yes , then click Self Enroll
- Go to canvas.msstate.edu to confirm the course is available to you on the Dashboard.
- Note - you might need to scroll down past any announcements.