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DIPLOMA IN CLINICAL RESEARCH

Syllabus of Diploma in Clinical Research

1. INTRODUCTION  TO  CLINICAL  RESEARCH
Definition, Types and Scope of Clinical Research, Good Clinical Practices
Drug Development Process
Careers in Clinical Research

2. ETHICS  IN  CLINICAL  RESEARCH

Ethical Theories and Foundations,
Ethics Review Committee and Informed Consent Process,
Integrity & Misconduct in Clinical Research
Conflicts of Interest

3. REGULATIONS IN CLINICAL RESEARCH
Evolution and History of Regulations in Clinical Research, Patents US Regulatory Structure, IND, NDA, ANDA, Post Drug Approval Activities, PMS, FDA Audits and Inspections EURegulatory Affairs, EMEA Organization and Function, INDIAN Regulatory system, Schedule Y- Rules and Regulations

4. CLINICAL RESEARCH METHODOLOGY 

Designing of Protocol, CRF, e-CRF, IB, ICF, SOP Pharmaco-epidemiology, BA/BE Studies Report writing, Publication

5. CLINICAL RESEARCH MANAGEMENT 

Preparation of a successful clinical study, Study management, Project management Documentation, Monitoring, Audits and Inspections Pharmacovigilance Training in clinical research Budgeting in clinical research, Supplies and vendor management

6. BIOSTATISTICS AND DATA MANAGEMENT 

Importance of statistics in clinical research Statistical considerations at the design, analysis and reporting stage. Data management, Data validation, SAE reconciliation, query management Software considerations


Eligibility
Graduates in Life Sciences, Pharmacy and Medicine with 55% aggregate marks.

The Diploma Program is available in two modes


1. Campus Based
Classes are held on weekends (Saturday/Sunday). The curriculum is covered in course attendance of 8hrs X 28 days.

2. E-Learning
Click here to go to e-learning


     
       
       
       
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