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Clinical Data Research Training Sector 46 Gurgaon, Clinical Data Research Training Institutes & Training Centers Sector 46 Gurgaon, Clinical Data Research Training Classes Sector 46 Gurgaon

List of Best Clinical Data Research Training Institutes Sector 46 Gurgaon, Clinical Data Research Training Centers Sector 46 Gurgaon, Clinical Data Research Course Training classes Sector 46 Gurgaon, Clinical Data Research Cocaching Classes Training Sector 46 Gurgaon, Clinical Data Research Placement Training Sector 46 Gurgaon with address, Phone numbers, course fee, student reviews and training course learning at Sector 46 area in Gurgaon City. As of April 27, 2018, We have total of Clinical Research training institutes in and around also near to Sector 46 in Gurgaon.

 

 

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Clinical Research course Content / syllabus at sector-46, gurgaon.

We gathered most widely used Clinical Research course content used by training institutes in sector-46,gurgaon. The Clinical Research course syllabus covers basic to advanced level and it may vary based on Clinical Research training classes offered in sector-46.

 

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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