Good Clinical Practice (GCP) Training

Good Clinical Practice 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 participants are protected.

NIH has issued a policy on GCP training for National Institutes of Health awardees involved in NIH-funded clinical trials. This policy requires that primary investigators and clinical trial staff involved in all new and ongoing NIH-defined clinical trials complete GCP training by Jan. 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 UMCIRB. 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.

GCP Training Links

GCP Frequently Asked Questions

Who is required to complete the GCP training?

All key research personnel involved in NIH-funded clinical trials are expected to document the completion of GCP training. Key research personnel include principal investigators, sub-investigators, research coordinators, and any other research team members who are involved in the design, conduct or reporting of clinical trials involving human participants.

Which GCP modules should I complete?

Select the following course applicable to the research in which you are involved to satisfy the requirement for GCP training:

If you are involved in biological, drug or device research, as well as social and behavioral research you are required to complete the CITI GCP training for clinical trials involving drugs, biologics and devices. If you have taken the CITI GCP training for biologics and drugs and devices you do not have to take the additional social and behavioral GCP training if you are involved in social and behavioral research.

When do I need to complete this training?

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. The new NIH policy requires GCP training be refreshed every three years in order to remain current with regulations, standards and guidelines.

How long will it take to complete the modules?

This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete. Researchers familiar with these topics may require three hours or less to complete all of the required modules. You do not have to complete all the modules at once. Both the CITI and SMB training sites are designed for you to work at your own pace and allow you to exit and return at a later date to where you left off.

What is considered a passing score?

The required passing score if you are taking the CITI modules is 70%. The score is based on the overall score from all the required modules. You may check your grade by selecting the grade book link on the welcome page or at the end of the course. If you do not pass, you can return to the modules and re-take the quizzes.

The required passing score if you are taking the SBM modules is 100%. This has been set by the Society for Behavioral Medicine who sponsors and administers the training site. If you do not pass the quizzes with a score of 100%, you will be given the option to retake the quizzes until you score 100%.

What if I have completed GCP CITI training at another institution?

If you are a new faculty, staff or student at ECU and have completed the same GCP CITI training modules at another institution within the last three years, you may log into the CITI site with the CITI username and password you created when you registered to use CITI and you may choose to “affiliate with another institution.” When you do this, select “East Carolina University.” If you have completed the SBM modules within the last three years at another institution you should upload a copy of the certification of completion in your ePIRATE profile.

What if I have completed GCP training through a different site such as the NIH?

If you have successfully completed GCP training through another site within the past three years, we will accept this training. When you update your ePIRATE profile with your GCP training information, please upload a copy of the certificate of completion.

How do I verify my GCP training to the UMCIRB?

To verify successful completion of the required CITI training, you must log the completion date (PDF) in your ePIRATE profile. Once a person’s CITI or SBM training date is logged in their ePIRATE profile, it will be automatically populated in any new study submission received by the UMCIRB. Do not forget to update your ePIRATE profile when you complete the required refresher course every three years.

Why am I having trouble viewing the CITI site?

To make full use of the features of the CITI site, and to do so securely, use a current browser version when accessing CITI Program. The vast majority of browsers made available within the last three to four years will support all CITI Program features. Older versions may not, as they are often less secure and provide less functionality.

Is there a fee?

Individual users who are taking the CITI or SBM GCP training as required by NIH are not assessed a fee for the training.

What if I have questions?

You may contact UMCIRB at 252-744-2914 or contact us via email at UMCIRB@ecu.edu.