CLINICAL RESEARCH

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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  
           a. Sponsor 
           b. Investigators 
           c. Clinical research associate 
           d. Auditors 
           e. Contract research coordinators 
            f. 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