Good Clinical Practice (GCP) is the international ethical and scientific standard expected in the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial subjects are protected.
Effective October 1, 2014, all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects AND a drug, device, or biologic are expected to document completion of GCP training.
NIH has also issued a policy on Good Clinical Practice training for NIH Awardees involved in NIH-funded clinical trials. This policy requires that PIs and clinical trial staff involved in all new and ongoing NIH-defined clinical trials1 complete Good Clinical Practice (GCP) training by January 1, 2017. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to trial design, conduct, and reporting. GCP training is in addition to, and different from, Human Subject Protection training, which is required by the IRB. Some specifics about the policy:
- This Policy applies to investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials.
- For new NIH-funded clinical trials, you must provide documentation of training completion as part of the Just-in-Time process. It is not yet clear how NIH will implement this requirement for ongoing awards.
- Click here to check your current training records (select GCP from training type menu).
GCP Training for Drugs, Devices or Biologics
UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects AND a drug, device, or biologic are expected to document completion of GCP training via the CITI program. The completion of the initial training is effective for 3 years. At the end of a 3 year period, a GCP refresher course will be required. You will be notified, via email, prior to the expiration date to remind you to complete the refresher course.
There are 17 modules which must be completed in order to satisfy the expectation for this training. Each module consists of an introduction, content pertinent to the subject, a list of references, and a quiz. Each module takes approximately 15 minutes to complete. The learner must achieve an average score of 80% on all quizzes. The modules may be completed in stages (i.e., you do not have to complete the entire course in one session).
The required modules cover information that meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Additional elective and supplemental modules for device trials are identified in Groups 2 and 3, but are not required.
GCP Training for Social Behavioral Research
Good Clinical Practice training that is more relevant to the Social and Behavioral Researcher PI and clinical trial staff involved in all new and ongoing clinical trials is now available on the UNC School of Social Work web page. This training meets the requirements set forth in the new policy on GCP Training for NIH-Funded Clinical trials which becomes effective January 1, 2017.
If you are involved in any biological, drug or device trial in addition to social and behavioral research you are still required to complete the GCP training from CITI. If you have taken the CITI GCP training for drugs/devices and biologics you do not have to take the additional social and behavioral GCP training.
The new GCP training for Social and Behavioral Researchers can be accessed in two different ways:
CITI website access for Faculty, Staff or Students having a valid ONYEN:
If you DO NOT have a valid ONYEN, access the CITI website at https://www.citiprogram.org. You will need a USERNAME and Password to log in. (If you believe you already have a USERNAME, please contact OCT at firstname.lastname@example.org and request your USERNAME be emailed to you.)
Once logged in,
- Click on Add a Course.
- Click on “I would like to review the Good Clinical Practice (GCP) modules” and click Next.
- Click on “GCP Social and Behavioral Research Best Practices for Clinical Research” and click Next.
- The course will be added to your UNC-Chapel Hill Courses.
from the School of Social Work website (http://ssw.unc.edu/sswevents/).
- Login using the ONYEN option on the left side.
- Click on the “Online Courses” tab near the top.
- Click the Registration/Details link and follow the directions on the resulting page.
If you have further questions regarding this requirement, please contact the Office of Clinical Trials at email@example.com or (919) 843-2698.
***PLEASE NOTE – the GCP training is in ADDITION to the requisite Human Subjects Protection modules required by the Office of Human Research Ethics.