Good Clinical Practices (GCP)

Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality standards that govern the design, conduct, monitoring, recording, auditing, reporting, and documentation of clinical trials involving human subjects. GCP ensures that the rights, safety, and well-being of trial participants are protected and that the data collected from these trials are credible and reliable.

Key principles of Good Clinical Practice include:

  1. Trials must be conducted in accordance with ethical principles that prioritize the rights, safety, and well-being of trial participants.
  2. Participants must provide voluntary, informed consent before participating in a clinical trial. They must be fully informed about the trial’s purpose, procedures, risks, and benefits.
  3. Investigators conducting clinical trials are responsible for ensuring that the trial is conducted in compliance with the protocol, GCP, and applicable regulatory requirements.
  4. Clinical trials must adhere to a detailed protocol outlining the study objectives, methodology, participant eligibility criteria, treatment procedures, and data collection methods.
  5. All data collected during a clinical trial must be accurately recorded, reported, and verified to ensure integrity and reliability.
  6. Clinical trials must include procedures for monitoring participant safety throughout the trial, including adverse event reporting and safety assessments.
  7. Trials must incorporate measures to ensure the quality and integrity of the data collected, including adequate training of trial staff, proper documentation, and regular auditing and monitoring.