A GCP (Good Clinical Practice) training workshop on “Empowering Clinical Research” has been held by the upcoming PA Sangma International Medical College & Hospital (PIMCH) at the University of Science and Technology Meghalaya (USTM). The    workshop was organized by PIMCH in collaboration with INFOCLIN Consultancy.

The resource persons for the workshop were Prof (Dr) Subhrojyoti Bhowmick, M.D, FISQua (UK) Clinical Director, Academics, Quality & Research, Peerless Hospital and B K Roy Research Centre, Kolkata; Prof (Dr) Anita Dakua, Associate Prof, Department of Pharmacology, PIMCH; Sabari Dasgupta, Senior Clinical Trial Monitor, INFOCLIN and Prof (Dr) Pinaki Chakravarty, Head, Department of Pharmacology, Tezpur Medical College. The workshop was participated by faculty, physicians, and students of the University.

Making his presentation on “ICH-Good Clinical Practice (GCP): Essential understanding for conducting Clinical Research”, Prof (Dr) Subhrojyoti Bhowmick said, “GCP is a shared responsibility of Sponsor, Investigator, Regulatory Authority and Ethics Committee”. According to him, the Ethical Principles of GCP are Essentiality, Voluntariness, Informed consent and community agreement, Non-exploitation, Privacy and confidentiality, Precaution & risk minimization, and professional competence. He stated that the Indian GCP Guidelines are developed by the Central Drugs Standard Control Organisation (CDSCO). These evolved with consideration of WHO, ICH, USFDA European GCP, and Ethical Guidelines of Biomedical Research on Human Subjects of ICMR.

Dr Bhowmick stated that GCP should be followed for carrying out biomedical research in India at all stages of drug development, whether before or after product registration in India. Good clinical practice involves a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that assures that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.

Addressing the gathering on the Sponsor's Responsibilities, Prof (Dr) Anita Dakua said that the Investigator should ensure the accuracy, completeness, legibility, and timelines of the data reported to the sponsor in the case report forms. Ms Sabari Dasgupta also presented a PPT on the Sponsor's Responsibility. On the other hand, Prof Pinaki Chakravarty from Tezpur Medical College spoke on NDCT Rules 2019 and Safety Reporting.