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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 (
  • 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:

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