McLaren Health Care
Application of GCP to the Conduct of Clinical Research

Application of GCP to the Conduct of Clinical Research

What is Good Clinical Practice (GCP)?

Established by the International Conference on Harmonization (ICH) in 1996, Good Clinical Practice (GCP) is an international ethical and scientific quality standard for research trials that involve the participation of human subjects. Formally known as ICH-GCP, the term GCP is also used more narrowly to describe the International Council for Harmonisation ICH GCP E6 document itself.  GCP guidelines describe the responsibilities of investigators, sponsors, monitors, and IRBs. The thirteen 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. Although these principles were written with drug, device, and biological studies in mind, most of these principles also apply to social and behavioral research.

Compliance with ICH-GCP Guidelines

The United States Food and Drug Administration (FDA) adopted the ICH GCP E6 (R2) Integrated Addendum as guidance in March 2018.

On 16 September 2016, the National Institutes of Health (NIH) issued a new policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148). The NIH (2016) policy states that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

Industry-sponsored studies with contract requirements for institutional adherence to ICH GCP guidance (E6) 

MHC IRB will comply with all the GCP statements outlined in ICH-GCP guidance (E6), provided that (i) the PI indicates in the iRIS application that the sponsor requires the IRB review process to comply with ICH standards (ICH GCP E6 3.1), and (ii) confirmation it is a contractual/agreement requirement.  In protocols or contracts/agreements, when the international standards are to be followed, it is referred to as ICH GCP. GCP as adopted by the FDA may also be referred to as: Good Clinical Practice, GCP, ICH GCP as adopted by the FDA, GCP as ratified by the FDA, or GCP as described in the FDA Regulations.

McLaren Health IRB commits to compliance with the International Conference on Harmonisation-Good Clinical Practices (“ICH-GCP”) E6 to the extent ICH-GCP E6:

• is consistent with applicable federal regulations
• defined in clinical trial contract agreement with sponsors
• required by funding agency

GCP Training Requirement

GCP training aims to:

• Ensure the rights and welfare of subjects are protected
• Ensure integrity and reliability of data derived from clinical trials
• Ensure Sponsor requirements are met
• Trials are conducted in accordance with approved plans
• Address investigator and study staff requests for training
• Facilitate audit preparation and improve outcomes

McLaren Health Care Research Integrity department / MHC IRB recognizes that GCP training is important for all researchers conducting “clinical trials”.  MHC IRB will now monitor GCP training as required by sponsors or funding agencies. Effective April 7, 2023, the Institutional Review Board (IRB) will not approve a new protocol submission that requires adherence to ICH GCP E6, unless GCP training is complete. GCP training must be completed before participating in any research activities. 

Individuals seeking training in Good Clinical Practice (GCP) may complete one of four available Collaborative Institutional Training Initiative (CITI) web-based courses:  

• Good Clinical Practice for Clinical Trials with Investigational Drugs and Devices (US FDA Focus). This course includes references to FDA regulations and guidance. In addition, this course meets the minimum criteria for ICH GCP training as recognized by TransCelerate BioPharma to allow mutual recognition of GCP training among trial sponsors and NIH requirements (https://about.citiprogram.org/news/citi-program-gcp-training-complies-with-nih-policy)
• Good Clinical Practice Social and Behavioral Best Practices for Clinical Research . This course is suitable for social and behavioral investigators and staff who must be trained in GCP. The GCP – Social and Behavioral Research Best Practices for Clinical Research course introduces GCP principles and discusses how they apply to clinical trials using behavioral interventions and social science research.
• GCP for Clinical Investigations of Devices (formerly called GCP Course for Clinical Trials Involving Investigational Medical Devices (international focus). This GCP Device Basic course is intended for research personnel involved in investigations of devices. It includes FDA regulations and guidance as well as International Organization for Standardization Guidelines ISO 14155:2020. It also provides an overview of investigator obligations in conducting clinical investigations of devices, as well as managing investigational devices according to GCP requirements, monitoring, audits and inspections, and informed consent for clinical investigations.
• GCP for Clinical Investigations of Drugs and Biologics (ICH) (formerly called GCP for Clinical Trials Involving Investigational Drugs (international / ICH focus) . This course is intended for research personnel involved in drug and biologic studies and who would benefit from a more internationally focused training, or for researchers involved in studies where compliance with ICH is required (for example, most industry-funded studies). This course 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.

Completion of a CITI basic human subjects protections course is a prerequisite for taking the GCP course.  GCP training is not a replacement for taking human subject training. GCP training must be renewed every three (3) years upon initial certification expiration, if the study team member is involved on an active clinical trial.   McLaren Health Care IRB will accept GCP training from the following:

• NIH https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
• Industry sponsors (e.g., organizations, etc. registered with TransCelerate Biopharma Inc.'s GCP Training Mutual Recognition program)
• Federal sponsors (e.g., NIH's NIAID GCP or National Drug Abuse Treatment Clinical Trials Network GCP)

Frequently Asked Questions

Do I have to complete this training?

Unlike human subjects’ research training, not everyone needs to complete GCP training, even though they may have contact or interactions with research subjects or with their private, identifiable information.  The requirement to complete this training is usually determined by your funding source.  All investigators and staff who are involved in the conduct, oversight or management of NIH-funded clinical trials are required to complete training in Good Clinical Practice (GCP) and refresh this training every 3 years, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). Information on this training requirement can be found here. 

Other sponsors may also require this training; you will need to check with the sponsor to see if they have specific GCP training requirements.

Does my GCP certification expire even if I do not have NIH funding?

Yes. Due to programming constraints within the CITI website, there is no way to distinguish learners who are completing GCP training for an NIH funded study from those that are completing GCP training for a different sponsor that may not require GCP training to be renewed every 3 years. Even if your sponsor does not require renewal, you may still receive the automated email reminders from CITI that your GCP training will expire soon.  It is the responsibility of the individual to ensure that they are compliant with their sponsor’s requirements.

How do I add a GCP course if I’m already a registered user that is affiliated with the McLaren Health Care?

Please visit the HRPP Education and Training page for more information.

How do I know which GCP course I should take?

If you have never completed training in Good Clinical Practice, you will want to select the first option on the ‘Good Clinical Practice (GCP) Course Enrollment’ screen.  You will automatically be enrolled in the basic GCP course.

If you have previously completed the ‘Good Clinical Practice Course, (US FDA Focus’ course)’ you will automatically be enrolled in the refresher GCP course.

I am only involved in social or behavioral research. I do not do studies with drugs or devices. Am I subject to this requirement?

Possibly. Some social and behavioral NIH funded studies may be require GCP training. NIH now requires that all "clinical trial staff", e.g., "individuals responsible for study coordination, data collection, and data management", working on a "clinical trial", e.g., "research studies in which one or more human subjects are prospectively assigned to one or more interventions....", completed GCP training.   A new, expanded definition of “clinical trial” includes social and behavioral research. Studies that are designed and executed in accordance with best practices often run more smoothly, better protect research participants, and reduce study non-compliance. Please see the NIH website by visit the link  https://obssr.od.nih.gov/training/download-good-clinical-practice-social-and-behavioral-research-elearning-course

I’ve never used the CITI Website before. How do I create a new account on the CITI website for the McLaren Health Care and register for a GCP course?

For more information on completing the GCP Course, please visit the HRPP Education and Training page.

What if I my study is not funded by the NIH but by a different sponsor? What are their requirements?

If your study is not funded by the NIH, but by another sponsor, you will need to check with the sponsor to see what their requirements are for GCP training.

Where do I go to take this training?

Investigators at McLaren Health Care that are required to complete GCP training can complete an education program through the Collaborative Institutional Training Initiative program (CITI). McLaren Health Care IRB will accept GCP training from the following:

• NIH https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
• Industry sponsors (e.g., organizations, etc. registered with TransCelerate Biopharma Inc.'s GCP Training Mutual Recognition program)
• Federal sponsors (e.g., NIH's NIAID GCP or National Drug Abuse Treatment Clinical Trials Network GCP)

Who is responsible for keeping track of my GCP certification?

MHC IRB does not keep copies of individual CITI program course completion records. Entry of certifications into the Certified Investigator’s database is the only record that the MHC IRB maintains for CITI program course completions. It is the responsibility of the individual to maintain a record of their own GCP certification.

Will I be notified when my GCP training is about to expire?

You will receive automated reminder emails from CITI prior to the expiration date of your GCP certification.  These will be sent out at 90 days, 30 days and 7 days prior to the expiration date of the last completed stage.  If your certification expires, you will NOT receive any additional notification from either CITI or the MHC IRB.

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