Good Clinical Practice Training
Good Clinical Practice (GCP) is an international, ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible.
Northwestern University and the Feinberg School of Medicine require GCP training for all investigators, co-investigators and study personnel listed on the Northwestern University IRB application and involved in research defined as follows by the NIH clinical trial definition: “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.”
To meet the GCP training requirement, you must complete one of the following:
- ACRP Good Clinical Practice: An Introduction to ICH GCP Guidelines
- ACRP GCP for the Experienced CRC (recommended as a refresher)
- ACRP GCP for the Experienced Investigator (recommended as a refresher course)
- CRC Basic Training Course
- CITI GCP Course (please note that the CITI Human Subjects Protections course does not fulfill the requirement)
- NIH Clinical Research Training online from the Office of Clinical Research Training and Medical Education
- NIH GCP for Social and Behavioral Research
- Industry-sponsored GCP training approved by TransCelerate
To find courses on MyHR Learn, follow the links above, type "GCP" in the search bar, then select the course. Additional instructions can be found in the MyHR Learn Training Guide.
Proof of ACRP Course Completion in MyHRLearn
If you have completed an ACRP course through MyHR Learn and would like to download a certificate of proof, please download and follow these instructions: ACRP Certificates Directions.
If you are already trained from an outside resource and have a certificate of proof, please submit proof of training compliance to REDCap for review and tracking.
Frequently Asked Questions Drop Down Arrows Below!
How often do I need to be trained?
Does your Northwestern NetID/password link with your existing CITI account?
It should. If it doesn't, read these instructions for registering or linking your existing CITI account.
If I would like to take one of the ACRP GCP courses through MyHR Learn, what information do I need to login?
Log in to MyHR Learn using your Northwestern University NetID and password.
If you are unable to login with you NetID or cannot access the GCP course, you must submit an email to firstname.lastname@example.org.
If you are not a current Northwestern University employee or student, a POI ID may be required in order to access and complete training in the MyHR Learn system. In these cases, a form will be provided for you to complete to request a POI. Please note that people other than active University faculty, staff or students must have a University sponsor to assist them in gaining the affiliate credentials needed to access MyHR Learn.
Who should I contact if I have additional questions?
Please email email@example.com.