Two days Good Clinical Practice on Current regulatory and ethical requirements for conducting clinical trials/research in India
DATE OF POST: May 16, 2019
The Dr. NTR University of Health Sciences, Vijayawada, Andhra Pradesh has 249 affiliated institutions (medical, dental, nursing, paramedical, AYUSH, etc.) under its patronage. The University strives towards creating a conducive research environment and promotes continual opportunities for learning. To take this ahead, the University under the aegis of Clinical Development Services Agency (CDSA), an extramural unit of Translational Health Sciences and Technology Institute (THSTI), Department of Biotechnology, Ministry of Science and Technology, Government of India had organised a two days training program on “Good Clinical Practice, Current regulatory and ethical requirements for conducting clinical trials/research in India’’ at the meeting room of Dr. NTR University of Health Sciences, Vijayawada on January 31-February 01, 2019.
The main objective of the training was to strengthen and empower the Institutional Ethics Committee (IEC) members to ensure that they understand scientific, regulatory norms, ethical design, conduct and reporting of clinical research that will be of uniform in nature and meets national and international quality standards. The course attempts to provide comprehensive training on effective and ethical conduct of clinical research. The outcome of this program was to seek cognizance on all the requirements (regulatory and ethical) necessary for conducting clinical trial/research so that each institution can form and register their human research committees. This program also geared them up for seeking accreditation for their ethics committee.
155 participants representing 31 institutions across Andhra Pradesh and all India had registered and participated in this program. The participants were majorly represented by the Dr. NTR University of Health Sciences, Vijayawada. The other institutions were AIIMS, Manglagiri; Osmania Medical College, GVK, etc.
Andhra Pradesh Medical Council awarded four (04) Continuing Medical Education (CME) credit points to all medical professionals attending this program. There was a written exit assessment leading to the award of certificate of program participation.