Good Clinical Practice FAQs
These FAQs provide clarification to the Research Policy Handbook Chapter 5.7, Training in the Protection of Human Subjects in Research.
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- Who needs to take the GCP training?
- How do I log in to CITI training?
- When I log into CITI, which Learner Group do I need to complete?
- When do I need to complete the GCP training?
- How do I access my certificate of completion?
- Do I need to complete it all at once or can I log out, log back in and continue?
- How can I determine if I have completed the correct Group(s)?
- Does the training expire? How often must I retake it?
- How can I determine if my training is current?
- Is this training adequate for all human subjects research?
- What if I already completed GCP training through an entity other than CITI (e.g. NIH GCP training, FDA GCP training, etc.)?
- If GCP training occurs outside of CITI, how and where will it be tracked?
- I already took GCP training because my study was a cancer center study? When must I retake the GCP training?
Who needs to take the GCP training?
The NIH requires GCP training for NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html. In addition, Stanford requires GCP training for all human subjects clinical trials, regardless of funding source for anyone involved in the design, conduct, recording, and reporting of research. The study PI is responsible for identifying the staff that should take the training.
How do I log in to CITI training?
Information on the training and a link to the CITI Website is available on the Research Compliance Office website: https://researchcompliance.stanford.edu/hs/new/resources/training/citi.html .
When I log into CITI, which Learner Group do I need to complete?
The only group that provides GCP training is Group 7. Note that this combines both human subjects and GCP training.
When do I need to complete the GCP training?
Your institutional official (RMG, OSR or ICO) will verify training has been completed before releasing any new NIH clinical trial award received after January 1, 2017. The IRB will require confirmation that the Protocol Director and staff have completed GCP for NIH sponsored clinical trials before approving in eProtocol.
How do I access my certificate of completion?
For instructions, go to: https://researchcompliance.stanford.edu/hs/new/resources/training/citi.html#certificate
Do I need to complete it all at once or can I log out, log back in and continue?
You can leave and go back to the training by logging back in as often as necessary. All training completed will be stored in the CITI system.
How can I determine if I have completed the correct Group(s)?
You must complete Group 7 in CITI or have completed CITI Group 8 in the last 3 years. The Training Status report will show you the Group(s) you have completed.
Does the training expire? How often must I retake it?
GCP is required to be taken every 3 years.
How can I determine if my training is current?
Go to https://citi.stanford.edu/ to see your Training Status report. You’ll have to download the file and search for your name.
Is this training adequate for all human subjects research?
Yes, Group 7 will cover both the medical human subjects and GCP training requirements.
What if I already completed GCP training through an entity other than CITI (e.g. NIH GCP training, FDA GCP training, etc.)?
You must retain documentation of the training (e.g., a certificate of completion) as proof of GCP training completion and provide the certificate if requested (below). In addition, once your current training has expired (3 years after the training completion date), you should take the CITI training Group 7.
If GCP training occurs outside of CITI, how and where will it be tracked?
You must retain documentation of GCP training that is taken outside of CITI to provide to RMG/OSR at the time of award.
