Father Muller Research Centre : GCP Training
Training
on good clinical practice (GCP), and Ethical guidelines for the conduct of
biomedical and health research was
conducted by FMRC on 6th October 2021. This training was third in the series of GCP
training initiated by FMRC in December 2020. Forty-five participants, including the faculty of Father Muller Medical College, Nursing staff who participate as team
members of Clinical Trials, Ethics committee members of FMCI, and staff of FMRC
attended the interactive lectures and discussions.
The
program was conducted in the Hospital conference hall from 8.30 am to 4.30 pm.
The training started with a pretest and ended with post-test and feedback from
participants.
In
the sessions, Dr. B. Sanjeev Rai, Chief of Research, oriented the participants
about the "basics and process of clinical trials"; Dr. Shivashankara AR (Professor
of Biochemistry and Member Secretary of FMIEC) deliberated on "ICMR guidelines
on Ethical conduct of biomedical and health research", "ethical review
procedures", and "risk-benefit assessment"; Dr. Sudhir discussed "informed
consent, privacy, confidentiality,""research misconduct and GCP non-compliance".
Dr.
Ashok Shenoy (Professor of Pharmacology, KMC Mangalore and Chairperson of
FMIEC) deliberated on "Principles of GCP", "New Drugs and Clinical Trials Rules",
"safety in clinical trials and compensation", "academic trials", and "roles and
responsibilities of sponsors and investigators".
Documentation
in clinical trials was elaborated by Dr. Deny and Ms.Prathima, staff of FMRC
and "quality assurance, audits and monitoring" was explained by Ms. Vanya,
staff of FMRC.
There
was an exclusive question and answer session in which participants could clear
their doubts and this session involved discussions on current ethical issues in
clinical research. The participants would be submitting assignments on
07.10.2021.
Dr
Shivashankara AR was the organizing secretary of the training, ably guided by
Dr B Sanjeev Rai, and supported by the staff of FMRC. The team of FMRC is
grateful to the management of FMCI for the support and encouragement in
conducting this programme.
