What is the Origin of Good Clinical Practices (GCP)?

The need for GCP arose historically from unethical medical experiments and the subsequent desire to standardize clinical research globally, leading to the development of the Declaration of Helsinki and the ICH (International Council for Harmonisation) guidelines. The term itself is descriptive, indicating a consensus on the "good" and "clinical" standards necessary for ethical research. These practices form the foundation of regulatory submissions worldwide, including those for hormone replacement therapies.

What is the Mechanism of Good Clinical Practices (GCP)?

GCP operates through a comprehensive framework that dictates specific procedures for informed consent, institutional review board (IRB) oversight, quality assurance, and detailed documentation. The mechanism is procedural, establishing clear roles and responsibilities for investigators, sponsors, and monitors to minimize bias and protect participants. It ensures the integrity of data used to evaluate the efficacy and safety of new hormonal compounds.

Good Clinical Practices (GCP) ∞ Area

Good Clinical Practices (GCP)

Meaning

Good Clinical Practices (GCP) are a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials that involve human subjects. Adherence to GCP ensures that the rights, safety, and well-being of trial participants are protected and that the data generated are credible and accurate. These standards are mandatory for the clinical development of new hormonal therapies and other pharmaceutical products globally.