Journal of Developing Drugs
Open Access

Challenges in implementing good clinical practice (GCP) guidelines and their mitigations

4^th International Summit on GMP, GCP & Quality Control

October 26-28, 2015 Hyderabad, India

Vineela Nekkanti

Rajiv Gandhi University of Health Sciences, India

Posters-Accepted Abstracts: J Develop Drugs

Abstract :

Good Clinical Practice (GCP) is a set of guidelines for biomedical research, which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. It primarily establishes the two main principles, i.e., Protection of rights of human subjects and authenticity of biomedical data generated. After the breach of subject rights during human experiments such as Nazi war crime, human radiation experiments and thalidomide tragedy, these guidelines came into existence in 1996, which are ubiquitously implemented in clinical research. Though the regulatory bodies maintain stringent norms to implement these guidelines, there are many discrepancies associated with it such as lack of professional training, safety reporting, Informed Consent Document (ICD) administration and record keeping, which thereby depletes the standards of clinical trials and authenticity of data generated. Hence, to overcome such limitations, certain measures have to be taken for the proper conduct of clinical trials.

Biography :

Email: vineelanekenti@gmail.com