PGD in Clinical Research

Department of Health and Life Sciences
Post Graduate Diploma in Clinical Research (PGDCR)

Clinical research is an important branch of healthcare science that defines and determines the safety and effectiveness (efficacy) of specific health and medical products and practices including medications, devices, diagnostic products and treatment regimens intended for human use which may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research describes many different elements of scientific investigation. It involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients. Clinical trials as well as research in epidemiology, physiology and pathophysiology, health services, education, outcomes and mental health can all fall under the clinical research umbrella.

Clinical researchers aim to advance medical knowledge by conducting studies that involve people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples. The Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India has highlighted that Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Compliance with this standard provides assurance to public that the rights, safety and well-being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki and ensures that clinical trial data are credible.

Program Objective

  • Should be able to understand New Drug Development process relevant to clinical research
  • Should be able to understand different roles & responsibilities of individual involved in clinical research
  • Should be able to comprehend and use elementary principles of regulatory guidelines as applicable
  • Will be to comprehend and implement ICH GCP principles while conducting clinical trials
  • Will be able to locate and assess the hospital site based on given norms for conducting clinical trial
  • Will be able to implement the study plan, check the manuscript in the trials and reports the deviations
  • Will be able to prepare protocol and CRF under supervision
  • Should be able to collect the CRF from the staff at site and be able to report in a given format
  • Will be able to identify the gaps for audit and inspection
  • Will be able to understand basics of clinical data management and medical writing