Good Clinical Practice (GCP) Training

GCP Regulatory Compliance Training

Good Clinical Practice (GCP) regulatory compliance training educates employees on best practices to comply with ICH-GCP guidelines. The responsibility to ensure compliance with GCP guidelines is shared by all the parties involved in conducting clinical trials. Consequently GCP training has become essential for all professionals involved in the planning, executing, monitoring, documenting, auditing, and reporting of clinical research to better understand its regulatory requirements. GMP training will also provide insight on common pitfalls identified during clinical investigations and how to avoid them.

GCP compliance assures that right, safety and well-being of trial subjects are protected and that the trial data are accurate and reliable. Failure to comply with GCP regulations can lead to hefty fines, debarment, damage to institutional reputation and even imprisonment. In one of the most recent cases, an European regulator has banned the sale of drugs approved on the basis of clinical trials conducted at GVK Biosciences India due to the plant’s non-compliance with GCP guidelines.

Good Clinical Practice is an international quality standard for conducting clinical trials that involves human subjects. GCP guidelines include standards for designing, conducting, recording and reporting of clinical trials. GCP guidelines also define the roles and responsibilities of ethics committee, clinical research sponsors and investigators.