About Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical and scientific standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. It is applicable for conducting biomedical and behavioural research involving human participants. This standard provides assurance that the rights, safety, well-being, and confidentiality of trial participants are protected. It is to ensure the data collected in clinical trials as well as the reported results of clinical trials are credible and accurate. The Good Clinical Practice guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants. Therefore, all trials should be conducted according to Good Clinical Practice (GCP) and all research staff should be trained and remain current in GCP. The principles in this guideline may be applied to all clinical investigations involving human participants, such as those involving an investigational product, a marketed drug, a medical device, or a behavioural intervention.

Certification in Good Clinical Practice

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable. The objective of this guideline is to provide a unified standard across the globe to facilitate the mutual acceptance of data from clinical trials by Regulatory Authorities.

This certificate programme is aimed at improving the conceptual knowledge of the participant for Good Clinical Practices and resolving any dilemmas that a working professional may face regarding the application of GCP guidelines. Successful completion of certification implies that the participant has in-depth knowledge and clear understanding of guidelines and regulations. Certificate program has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials. GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Several specialized topics have been added to guide the participant through international and Indian GCP regulations, compliance needs, comparison of various regulations. This training is important for all professionals and staff involved in Clinical Research and ensures an understanding of the principles adopted in research. GCP is widely accepted and expected in all research involving human participants.