‘Clinical Research – Theory’ is a course offered in the fifth year of Pharm. D. program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 3 Hrs./Week

1. Drug development process:Introduction

   Various Approaches to drug discovery

   1. Pharmacological
   2. Toxicological
   3. IND Application
   4. Drug characterization
   5. Dosage form
2. Clinical development of drug:
   1. Introduction to Clinical trials
   2. Various phases of clinical trial.
   3. Methods of post marketing surveillance
   4. Abbreviated New Drug Application submission.
   5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines
   6. Challenges in the implementation of guidelines
   7. Ethical guidelines in Clinical Research
   8. Composition, responsibilities, procedures of IRB / IEC
   9. Overview of regulatory environment in USA, Europe and India.
   10. Role and responsibilities of clinical trial personnel as per ICH GCP
       1. Sponsor
       2. Investigators
       3. Clinical research associate
       4. Auditors
       5. Contract research coordinators
       6. Regulatory authority
   11. Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
   12. Informed consent Process
   13. Data management and its components
   14. SAFETY MONITORING IN CLINICAL TRIALS.

Reference books:

1. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.
2. a. International Conference on Harmonisation of Technical requirements for registration of Pharma- ceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Prac- tice.E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.
5. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
6. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
7. Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Publications, 2001.