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Regulatory Standards

Good Clinical Practice (GCP): The Ethical Standard

Key Takeaways
  • GCP is the international ethical and scientific quality standard for clinical trials
  • It ensures participant safety, data integrity, and regulatory compliance
  • Understanding GCP principles helps brands run credible product studies
  • Reputable Health follows GCP guidelines in all verified evidence programs

What is Good Clinical Practice?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of trial participants are protected.

Originally developed by the International Council for Harmonisation (ICH), GCP guidelines are now recognized worldwide as the foundation for ethical clinical research. These principles ensure that data collected is credible and that participants are treated with dignity and respect.

Core Principles of GCP

GCP is built on fundamental principles that guide every aspect of clinical research:

Participant Rights

The rights, safety, and well-being of trial subjects are the most important considerations and should prevail over interests of science and society.

Scientific Soundness

Clinical trials should be scientifically sound and described in clear, detailed protocols that have been approved by an ethics committee.

Qualified Personnel

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform their respective tasks.

Informed Consent

Freely given informed consent should be obtained from every subject prior to clinical trial participation, documented appropriately.

Responsibilities in GCP

Sponsor Responsibilities

  • Ensure proper trial design and protocol development
  • Select qualified investigators and sites
  • Provide adequate resources and training
  • Maintain quality assurance and quality control
  • Handle and store investigational products properly

Investigator Responsibilities

  • Conduct the trial according to the protocol
  • Obtain proper informed consent from participants
  • Ensure participant safety throughout the study
  • Maintain accurate and complete trial records
  • Report adverse events promptly and accurately

Why GCP Matters for Health Products

Even when conducting observational studies or consumer research (rather than clinical trials), GCP principles provide a valuable framework for ensuring ethical conduct and data quality.

At Reputable Health, we apply GCP principles to our Verified Evidence programs. This means:

  • Participants always provide informed consent before joining studies
  • Data collection follows standardized, validated protocols
  • Participant privacy and data security are prioritized
  • Results are reported honestly and transparently