CLINICAL RESEARCH

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 guidelines
              - GCP guidelines
              - 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 
               - India.

   10. Role and responsibilities of clinical trial personnel as per ICH GCP  

• Sponsor 
• Investigators 
• Clinical research associate 
• Auditors 
• Contract research coordinators 
• 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