COURSE CONTENT :

1. Overview of CRO Industry in India

2. Clinical Research Terminology

3. Medical Terminology

4. Introduction to Clinical Research

5. Phases of Drug Development

6. Evolution of Ethics in Bio-Medical Research

7. Ethics

8. Informed Consent

9. Protocol

10. Investigator Brochure (IB)

11. Case Report Form-I

12. Forms and logs

13. e-CRF

14. Monitoring Responsibilities

15. Responsibilities of Investigator

16. Pharma co Vigilance-I

17. IND 21 CFR.312

18. Sponsor Responsibilities

19. Data Management

20. Fraud in Clinical Research

21. Responsibilities of CRA

22. Preparations of Study Reports

23. Scheduled ‘Y’

24. IVRS & Conflict of Interest

25. Project Management

26. ICH-GCP Guidelines.

27. FDA Guidelines

Eligibility : B.Pharmacy / M.Pharmacy / B. Sc / M. Sc (Life sciences), MBBS, M.D / B. Tech (Bio tech)

Duration : 30 - 40 days

For Details Contact :

DIGVIJAYA MANAGEMENT CONSULTANTS PVT LTD.
Flat No.207, A-Block, Prabhath's Signature,
Near Kalamandir, HMT Satavahana Road,
KPHB, Hyderabad - 500 072
Ph: 040-40064942, Mobile: +91-9348914666, +91-8121752466
Email: training@digvijaya.com
URL: www.digvijaya.com