'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
- Drug development process:
Various Approaches to drug discovery
- IND Application
- Drug characterization
- Dosage form
- Clinical development of drug:
- Introduction to Clinical trials
- Various phases of clinical trial.
- Methods of post marketing surveillance
- Abbreviated New Drug Application submission.
- Good Clinical Practice – ICH, GCP, Central drug standard control organisation (CDSCO) guidelines
- Challenges in the implementation of guidelines
- Ethical guidelines in Clinical Research
- Composition, responsibilities, procedures of IRB / IEC
- Overview of regulatory environment in USA, Europe and India.
- Role and responsibilities of clinical trial personnel as per ICH GCP
- Clinical research associate
- Contract research coordinators
- Regulatory authority
- Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment)
- Informed consent Process
- Data management and its components
- SAFETY MONITORING IN CLINICAL TRIALS.
- Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.
- 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.
- Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.
- Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.
- Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
- Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
- Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Publications, 2001.