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Clinical Data Research Training Shanthi Nagar Mangalore, Clinical Data Research Training Institutes & Training Centers Shanthi Nagar Mangalore, Clinical Data Research Training Classes Shanthi Nagar Mangalore

List of Best Clinical Data Research Training Institutes Shanthi Nagar Mangalore, Clinical Data Research Training Centers Shanthi Nagar Mangalore, Clinical Data Research Course Training classes Shanthi Nagar Mangalore, Clinical Data Research Cocaching Classes Training Shanthi Nagar Mangalore, Clinical Data Research Placement Training Shanthi Nagar Mangalore with address, Phone numbers, course fee, student reviews and training course learning at Shanthi Nagar area in Mangalore City. As of May 21, 2018, We have total of 1 Clinical Research training institutes in and around also near to Shanthi Nagar in Mangalore.

 

 

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Clinical Research course Content / syllabus at shanthi-nagar, mangalore.

We gathered most widely used Clinical Research course content used by training institutes in shanthi-nagar,mangalore. The Clinical Research course syllabus covers basic to advanced level and it may vary based on Clinical Research training classes offered in shanthi-nagar.

 

It includes various contents such as:
1. INTRODUCTION TO CLINICAL RESEARCH
1.Definition, Types and Scope of Clinical Research, Good Clinical Practices
2.Drug Development Process
3.Careers in Clinical Research

2. ETHICS IN CLINICAL RESEARCH
1.Ethical Theories and Foundations,
2.Ethics Review Committee and Informed Consent Process,
3.Integrity & Misconduct in Clinical Research
4.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

 

 

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