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Good Clinical Practice is 鈥渁n international, ethical, scientific, and quality standard for the conduct of trials that human participation.鈥� Adhering to these standards helps ensure participants are protected, ethical principles related to the conduct of research are upheld, and results are reliable. ^{[1, 2]}.

References to 鈥楪CP鈥� can sometimes be confusing because some research professionals use the term generically, to define how research is conducted, whereas others are actually referencing a specific guidance document on GCP.聽 The concept of GCP is, however, much broader than a single guidance document. Rather, GCP is 鈥渁n attitude of excellence in research鈥� ^[5] that encompasses the principles and obligations set forth in the various documents and regulations that guide the conduct of human subject research.

In other words, GCP is a compilation of the underlying principles described in the , , , [HHS] and [FDA] regulations, (hereinafter ICH GCP), and (hereinafter ISO 14155) ^{[3, 4, 5, 6,]}.

Common among these resources are standards (i.e., GCPs) related to:

• Conducting scientifically sound research that is of benefit to society;
• Ensuring a favorable risk:benefit ratio of the research;
• Ensuring subject safety prevails over societal benefit;
• Selecting subjects equitably;
• Obtaining independent ethics committee (i.e., Institutional Review Board [IRB]) approval);
• Protecting vulnerable populations;
• Conducting research in accordance with the approved study protocol;
• Obtaining voluntary informed consent;
• Limiting involvement in the conduct of research to those with adequate qualifications and experience;
• Appropriately accounting for investigational product;
• Protecting subject privacy and maintaining the confidentiality of the data;
• Assuring data integrity and quality; and
• Appropriately documenting the research.

The regulations and policies you鈥檙e required to comply with depend on the nature of your research and will vary from study to study based on who initiates the research, the interventions, procedures and risks involved, and the funding source.

From a regulatory standpoint, per institutional policy, all research conducted at the University of Rochester with human subjects must minimally comply with HHS regulations ().聽 If the research also involves a test article (drug, biologic, device [including in vitro diagnostic devices] or supplement) or is funded by the FDA, study staff must further comply with applicable FDA regulations (; ; ; ; ; ).聽 Additional regulations that may apply include:

• Regulations set forth by different HHS agencies such as the Department of Defense or Department of Education, when an HHS agency funds the research or when the agency imposes requirements based on the study population (e.g., students);
• Regulations defined by the Health Insurance Portability & Accountability Act, when the research involves the use and/or disclosure of protected health information by a covered entity;
• Tribal law, when the research is conducted in a setting governed by tribal law; and
• Regulations from other countries, when the research is conducted abroad.

Beyond regulatory compliance, study staff must also minimally comply with institutional policy, policy set forth by the Reviewing IRB, and the IRB-approved study protocol.

Guidance documents provide recommendations and best practices for how to comply with regulations; they are not, by definition, regulation. In fact, most guidance documents related to the conduct of human subject research published by HHS or the FDA state that the 鈥榞uidance represents the current thinking鈥� of the agency and the information provided is not legally binding ^[1].

So, when asked the question 鈥榙o I have to comply with guidance?鈥� the answer is technically no. However, given the variation in how regulations can be interpreted, following the advice provided in guidance documentation is strongly encouraged.

Study teams should equate guidance documents to a play book or treasure map; if someone provided you a play book that enhanced your ability to 鈥榩lay the game鈥� or a map of how to reach your goal, wouldn鈥檛 you follow it? Following the recommendations provided in published guidance documents betters your chances of protecting subjects, collecting quality data and minimizing non-compliance.

There is, of course, a caveat to this, most notably in regards to the and . These guidance documents set forth international GCP standards for investigational products; ICH GCP has been adopted as by the FDA and ISO 14155 has been recognized as a . These international GCP standards were developed to streamline the drug and device development process and facilitate mutual acceptance of international clinical data by corresponding regulatory authorities (e.g., as support for a marketing application, the US FDA will accept data collected by a trial conducted in Japan, provided the study was conducted in accordance with ICH GCP). As such, study sponsors will often require compliance with ICH GCP and/or ISO 14155 (commonly identified in study protocol, on the protocol signature page or in the investigator agreement).

To reiterate, if your study protocol, clinical trial agreement, or any other study-specific documentation indicates that compliance with ICH GCP, ISO 14155 or any other regulation or guideline is required, then the study team is responsible for complying with such requirements.

Despite the word 鈥榗linical鈥� in the phrase Good Clinical Practices, the general principles considered to be GCP (bulleted in the 鈥榃hat is GCP?鈥� FAQ above) still generally apply to social-behavioral research.

Remember, as stated previously: GCP encompasses standards across several potential sources of compliance, including ethical principles and federal regulations that apply to social-behavioral research. Moreover, guidelines identified specifically as 鈥楪CP鈥� guidance define best practices for reaching your study鈥檚 aims and conducting sound research. Those recommendations within the guidance that don鈥檛 apply to social-behavioral research (e.g. test article accountability), simply don鈥檛 apply, though many do (as validated by a survey conducted by Murphy, et al.) ^[4].

While the University of Rochester has not implemented an institutional policy requiring GCP training for study staff (only human subject protection training is required), GCP training may be required for study staff:

• Sponsors, Department Chairs and Administrators/Supervisors may require GCP training.
• Most industry sponsors conducting research involving investigational products (drugs, devices, and biologics) will require GCP training.
• The National Institutes of Health (NIH) require all 鈥渋nvestigators and staff who are involved in the conduct, oversight or management of clinical trials鈥� to complete and maintain GCP training. Of note, NIH鈥檚 definition of clinical trials includes trials that are behavioral in nature; the defines a clinical trial as 鈥渁s research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related or behavioral outcomes.鈥�

All new and inexperienced research personnel, including investigators and study staff, are strongly encouraged to complete GCP training regardless of whether it is required.

GCP training is available for all University of Rochester faculty, staff and students through the . To add GCP training to your training curriculum, reference . Note: When adding the course, trainees can opt to complete either a US FDA-Focused or Social-Behavioral-focused GCP course.

In lieu of CITI GCP training, sponsors may also accept training completed via another mutually recognized GCP training platform, as identified through Transcelerate BioPharma, Inc.鈥檚 鈥� (reference a list of. Questions regarding whether a certain type/platform for GCP training is acceptable should be directed to the party/entity requiring the training.

1. Food & Drug Administration (FDA) Guidance for Industry – E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R2). (2018, March). Retrieved March 30, 2020 from .
2. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH): Guideline for Good Clinical Practice E6(R3). (2025, January 6).聽 Retrieved January 23, 2025 from .
3. Moran, J., Stevens, E. & Statzel, J. (2013, May 09). Good clinical practice: Where ethics and quality meet. Regulatory Affairs Professional Society.
4. Murphy, S. L., Byks-Jazayeri, C., Calvin-Naylor, N., Divecha, V., Anderson, E., Eakin, B., Fair, A., & Denton, L. (2017). Best practices in social and behavioral research: report from the Enhancing Clinical 糖心logo Professional’s Training and Qualifications project. Journal of clinical and translational science, 1(1), 26鈥�32.
5. Silver-Kessler, R. (n.d.) The Fundamentals of Good Clinical Practice [white paper published by IMARC 糖心logo]. Retrieved March 30, 2020 from .
6. York, R. (n.d.) Good Clinical Practice: from review to application [white paper published by IMARC 糖心logo]. Retrieved March 30, 2020 from .