GCP workshop for clinical research at USTM

Syllad | The Rising MeghalayaJuly 4, 2024

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

The resource persons for the workshop were Dr Subhrojyoti Bhowmick, MD, FISQua (UK) Clinical Director, Academics, Quality & Research, Peerless Hospital and BK Roy Research Centre, Kolkata; Dr Anita Dakua, Associate Prof, Department of Pharmacology, PIMCH; Sabari Dasgupta, Senior Clinical Trial Monitor, INFOCLIN and Dr Pinaki Chakravarty, Head, Department of Pharmacology, Tezpur Medical College.

The workshop was attended by faculty, physicians, and students of the university. During his presentation on “ICH-Good Clinical Practice (GCP): Essential Understanding for Conducting Clinical Research,” Dr Subhrojyoti Bhowmick stated, “GCP is a shared responsibility of Sponsor, Investigator, Regulatory Authority, and Ethics Committee.”

According to Dr Subhrojyoti Bhowmick, the Ethical Principles of Good Clinical Practice (GCP) include Essentiality, Voluntariness, Informed Consent and Community Agreement, Non-exploitation, Privacy and Confidentiality, Precaution and Risk Minimization, and Professional Competence.

He mentioned that the Indian GCP Guidelines are developed by the Central Drugs Standard Control Organisation (CDSCO). These guidelines were formulated considering standards from the WHO, ICH, USFDA, European GCP, and the Ethical Guidelines for Biomedical Research on Human Subjects by the ICMR.

Dr. Bhowmick emphasized that Good Clinical Practice (GCP) should be adhered to for conducting biomedical research in India at all stages of drug development, whether before or after product registration. He explained that GCP provides a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. This ensures 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 emphasized that the Investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms.

Sabari Dasgupta also presented a PPT on the Sponsor’s Responsibility. Meanwhile, Prof. Pinaki Chakravarty from Tezpur Medical College spoke about NDCT Rules 2019 and Safety Reporting.