The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. GCP training aims to ensure that the rights, safety, and well-being of human subjects are protected, clinical trials are conducted in accordance with approved plans with rigor and integrity, and data derived from clinical trials are reliable.

In January of 2017, the NIH implemented a policy mandating that all NIH-funded clinical investigators and clinical trial staff be trained in GCP.

Whether GCP training is required depends on the type of study being conducted. Who needs to complete GCP training depends on their role. See UW-Madison Personnel or External Personnel below for more information.

To link previously completed training, see Instructions for Linking Previous CITI Training.

If you have questions or experience issues with the training, see Troubleshooting/FAQs. If you have remaining questions after reviewing Troubleshooting/FAQs and the below content, contact citisupport@research.wisc.edu or 608-262-1703. 

UW-Madison Personnel

Who needs to complete GCP Training?

Principal investigators as well as individuals involved in identifying/recruiting subjects, obtaining informed consent, or interacting and intervening with subjects (personnel listed as having those roles in the IRB application), when either of the following apply:

  • The study meets the NIH definition of a clinical trial AND evaluates a drug, device, or biologic or is conducted under one or more INDs, IDEs, or Non-Significant Risk Device determinations
    • CITI’s “Good Clinical Practice for Drug/Device Researchers” course is required for these studies, regardless of funding.
  • The study meets the NIH definition of a clinical trial AND is NIH-funded
    • Either CITI’s “GCP – Social and Behavioral Research Best Practices for Clinical Research” course OR the “Good Clinical Practice for Drug/Device Researchers” course can be completed.

NOTE: If personnel might be engaged in a clinical trial that evaluates a drug, device, or biologic or is conducted under one or more INDs, IDEs, or Non-Significant Risk Device determinations in the future, it is recommended they complete the “Good Clinical Practice for Drug/Device Researchers,” as it is the only GCP course that is accepted for clinical trials of that type.

Link to this section

GCP Completion Instructions for First-Time Users

If this is your first time completing GCP training at UW-Madison, follow the steps below:

  1. Log in to CITI via the UW CITI Portal using your NetID and password.
  2. Click “View Courses” next to the “University of Wisconsin-Madison.”
  3. Click “Add a Course” at the bottom of the page.
  4. In Question 3, check the box next to the appropriate GCP course (see the “Who needs to complete GCP training” tab for more information) and click submit at the bottom of the page.
  5. Click on the appropriate GCP course you added in step 2 to start the training. Follow the instructions within CITI to complete your training.
  6. Successful completion requires a composite score of 85% on the quizzes. Quizzes can be repeated in order to achieve this score. If needed, the course can be completed in multiple sessions. Course completions will load into ARROW and the Training Information Lookup Tool shortly after the next regularly scheduled database update, which occur multiple times a day.

Link to this section

What is an easy way to tell if this training requirement applies to my study?

Provided that your ARROW application is accurately completed, clicking “View Study Team Training” in the study’s ARROW workspace will indicate whether or not GCP training is required. The snapshot will also tell you which GCP course should be taken for that given study as well as the personnel who have not yet completed that appropriate course. You can also email citisupport@research.wisc.edu for help.

Link to this section

What if I have completed a GCP training course outside of CITI?

Only the CITI GCP courses listed in the “Who needs to complete GCP Training?” tab will be accepted for UW-Madison personnel.

Link to this section

GCP Refresher Completion Instructions

Training must be renewed every three years. You will receive an email reminder 90 days prior to your training expiration, and the new training will auto-populate into your account at that time.

Link to this section

External Personnel

Which external personnel need to complete GCP training?

Good Clinical Practice (GCP) training is required for external personnel listed on a research study if they are involved in identifying/recruiting subjects, obtaining informed consent, or interacting with subjects and one of the following applies:

External personnel affiliated with an institution or entity with an IRB

Applicable external personnel affiliated with an institution or entity with an IRB must complete training as required by their institution. The relying site’s IRB is responsible for ensuring its personnel have completed the training required by their institution. Training certificates do not need to be provided to the UW-Madison IRB; completion of the delegation log serves as confirmation that training requirements have been met.

External personnel NOT affiliated with an institution or entity with an IRB (individual investigators)

Applicable external personnel NOT affiliated with an institution or entity with an IRB (individual investigators) have the following options, depending on the type of research in which they are involved:

External personnel involved in the drug/device clinical trial research described above can complete either of the following:

CITI’s Good Clinical Practice for Drug/Device Researchers

  • Register via the CITI Program

  • In the section titled “Select Your Organization Affiliation”, type and select “University of Wisconsin – Madison”. DO NOT select “University of Wisconsin – Madison (SSO)”.

  • Read and check “I AGREE to the Terms of Service and Privacy Policy for accessing CITI Program materials” if you agree.

  • Check “I affirm that I am affiliate of University of Wisconsin – Madison”.

  • Click “Continue To Create Your CITI Program Username/Password”.

  • Continue through the additional steps to set up your profile. An email address issued by UW-Madison is NOT required under “Institutional Email Address”.

  • Complete question 3 and click submit at the bottom of the page.

  • Once you have the course in your account, click on the course title to begin the course and follow the instructions within CITI to complete your training. Courses can be completed in multiple sessions.

  • Successful completion requires a composite score of 85% on the quizzes. Quizzes can be repeated in order to achieve this score.

  • Once the course is complete, click “View-Print-Share Record” next to the course in your course list. Then click “View / Print” to print your Completion Certificate. Provide this certificate to the UW-Madison study team to document training completion.

Link to this section

National Institutes of Health (NIH)’s Good Clinical Practice training for Drug/Device researchers

  • Follow the instructions at National Institute on Drug Abuse
  • External personnel should create their own account and provide certificate to the UW study team.
  • Users should redo the training every three years to maintain training.

Link to this section

External personnel involved in NIH-funded clinical trials that do not evaluate drugs/devices can complete either of the GCP trainings described above or either of the following:

CITI’s Social and Behavioral Research Best Practices for Clinical Research

    • In the section titled “Select Your Organization Affiliation”, type and select “University of Wisconsin – Madison”. DO NOT select “University of Wisconsin – Madison (SSO)”.

    • Read and check “I AGREE to the Terms of Service and Privacy Policy for accessing CITI Program materials” if you agree.

    • Check “I affirm that I am affiliate of University of Wisconsin – Madison”

    • Click “Continue To Create Your CITI Program Username/Password”

    • Continue through the additional steps to set up your profile. An email address issued by UW-Madison is NOT required under “Institutional Email Address”.

    • Complete question 3 and click submit at the bottom of the page.

    • Once you have the course in your account, click on the course title to begin the course and follow the instructions within CITI to complete your training. Courses can be completed in multiple sessions.

    • Successful completion requires a composite score of 85% on the quizzes. Quizzes can be repeated in order to achieve this score.

    • Once the course is complete, click “View-Print-Share Record” next to the course in your course list. Then click “View / Print” to print your Completion Certificate. Provide this certificate to the UW-Madison study team to document training completion.

Link to this section

NIH GCP training for Social/Behavioral researchers via the Society of Behavioral Medicine

    • Complete the training via the Society of Behavioral Medicine 
    • External personnel should create their own account and provide the completion certificate to the UW study team.

    • Users can redo the training every three years to maintain training.

Link to this section