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Course Description and Career Prospects


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Biological Sciences

Biological Sciences

Clinical Research

Course Objective:

  1. Obtain a clear understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management.
  2. Professionals from Pharmacy, Medical, Nursing, Life Sciences, Research & Development, Clinical Research, Allied areas and Academic fields, a basic to advanced level understanding of various clinical trial processes.
  3. Enable participation in design, conduct and management of global clinical trials, conducted at multi-centric sites in India and overseas.
  4. Acquire an understanding of evolving regulatory processes, standards and practices of ICH GCP in the conduct of different therapeutic trials and in the preparation of submissions to be made to regulatory authorities in India and overseas.

Course Content

  1. A Historical Perspective on Clinical Research
  2. Clinical Epidemiology
  3. Evidence based medicine
  4. Clinical Research
    1. Introduction to Clinical Trials
    2. Clinical Trial Protocol
    3. Meta Analysis
    4. Quasi Experimental Techniques
  5. Good Clinical Practices (GCP)
  6. Laws Governing Clinical Research
  7. Ethical Principles in Clinical Research
  8. Informed Consent in Clinical Research
  9. Clinical Data Management
  10. Clinical Research Budgeting
  11. Clinical Research Audit and Inspection
  12. Clinical Research Frauds
  13. Statistics for Clinical Research
  14. Clinical Research Glossary

Career Prospects

Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization).

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