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 aims at advancing 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.
Fee : Rs. 25,000/Sem
The programme will be offered to candidates who have cleared Bachelor’s Degree in Life Sciences (Botany, Zoology, Microbiology, Biotechnology, Biochemistry) or Bachelor’s Degree in Pharmacy, Medical and Paramedical Sciences (MBBS, BDS, BPT, BHMS, BAMS, B.Sc. Nursing). Candidates with Master’s/Doctorate Degree of all above courses from a recognized university with at least 50% marks in Bachelor’s Degree are eligible for seeking admission to PGDCR programme.
(The admission will be granted only on submission of final mark sheet and satisfying the requirements at the time of admission)
The Department of Health and Life Sciences, TeamLease Skills University has introduced a One year (2 Semesters) – Full-time Programme in Post Graduate Diploma in Clinical Research (PGDCR) designed for individuals interested in entering the field of clinical Research. It will provide comprehensive knowledge of how to design and conduct a clinical trial successfully in compliance with regulatory requirements. In view of the nature of the course as well as the undisputable requirement of real time practical exposure, understanding, experience and training, this course will be offered in collaboration with Kailash Cancer Hospital and Research Centre, Muni Seva Ashram, Goraj, to ensure the candidate is equipped with holistic and dynamic skills required by a Clinical Researcher on completion of this programme.
After completion of this PGDCR programme, students should be able to understand New Drug Development process relevant to clinical research; to understand different roles & responsibilities of individual involved in clinical research; to comprehend and use elementary principles of regulatory guidelines as applicable; to collect the CRF from the staff at site and be able to report in a given format. They will be to comprehend and implement ICH GCP principles while conducting clinical trials; to locate and assess the hospital site based on given norms for conducting clinical trial; to implement the study plan, check the manuscript in the trials and reports the deviations; to prepare protocol and CRF under supervision; to identify the gaps for audit and inspection as well as to understand basics of clinical data management and medical writing.
Dr. Avani Umatt has a total of 16 years of experience including 12 years of experience in teaching; 16 years of research experience, 1.5 years of industrial and other academic experience. She has published 1 book, 9 research papers in Journals and Conference Proceedings, presented 5 research papers presented at National Conferences and guided 16 M.Sc. Projects. Her specialization is in the field of polymers and field of research includes developing and application of conductive polymers/ composites as well as modifying clay for stabilization of expansive soils with and without bio enzymes.
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