Good clinical practice

The following session will cover good clinical practice GCP, including its ethical and scientific standards for clinical trials and its evolution as a response to past research abuses. We will discuss the ethical foundations of GCP, the importance of informed consent, and the central role of participant rights and welfare. Key scientific requirements such as sound methodology, data integrity, and regulatory compliance will be addressed, along with the processes that ensure ongoing quality and compliance in clinical trials. This session explores the essentials of good clinical practice or GCP, international ethical and scientific standards for designing, conducting and reporting clinical trials involving human subjects. GCP is fundamental to credible research, protecting participant rights and well being while ensuring data reliability. Its evolution was shaped by past abuses and the need for global harmonization, underpinning legal and regulatory frameworks like the ICH, EMA and FDA. A core pillar of good clinical practice is its ethical foundation. Every trial must prioritize the rights, safety and well being of participants over scientific or business interests. This ethical framework is embodied in documents like the Declaration of Helsinki, Nuremberg Code, and Belmont Report, reinforcing respect for persons beneficence, and justice. Studies only begin if benefits outweigh risks with ethics committee review required.