Foundational Principles of ICH GCP

Let’s delve into the fundamental principles that shape the ethical conduct of clinical trials according to ICH Good Clinical Practice (GCP):

Ethical Foundation: Clinical trials must align with the ethical principles outlined in the Declaration of Helsinki, ensuring consistency with GCP and relevant regulatory requirements.

Balancing Risks and Benefits: Before initiating a trial, careful consideration must be given to the foreseeable risks and inconveniences, weighing them against the anticipated benefits for both the individual trial subject and society as a whole. Trials should proceed only if the benefits justify the risks.

Priority on Participant Well-being: The rights, safety, and well-being of trial subjects take precedence over scientific interests and societal considerations.

Data Adequacy: Prior to conducting a clinical trial, the available nonclinical and clinical information on the investigational product should be sufficient to support the proposed study.

Scientific Rigor: Clinical trials should be grounded in sound scientific principles and outlined in a clear, detailed protocol.

Protocol Compliance: Trials should adhere strictly to the approved protocol, following prior review and approval by an institutional review board (IRB) or independent ethics committee (IEC).

Qualified Medical Oversight: Medical care and decisions concerning trial subjects must be the responsibility of qualified physicians or dentists, as appropriate.

Expertise and Training: Every individual involved in conducting a trial should possess the necessary education, training, and experience to fulfill their respective roles effectively.

Informed Consent: Prior to participation, subjects must provide freely given informed consent after understanding the trial’s risks and benefits.

Data Integrity and Transparency: All information generated during the trial should be accurately recorded, securely handled, and stored to facilitate its proper reporting, interpretation, and verification.

These principles serve as the guiding framework for ethical and scientifically robust clinical research. Let’s uphold these standards as we work towards advancing healthcare outcomes and improving patient lives.

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Resource Person: Yan Hai, M.A.Sc.

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