ESSENTIALS OF CLINICAL RESEARCH

1 Introduction
2 Glossary & Drug Development Process
3 Clinical Trials on Drugs
4 Regulatory Strategy
5 Regulatory Control Over Drugs
6 Ethical Aspects of Clinical Research
7 Responsibility of Stakeholders
8 Clinical Trial Documents
9 Endpoints in Clinical Research
10 Site and Investigator Selection
11 Subject Recruitment and Selection
12 Meetings in Clinical Research
13 Data and Safety Monitoring
14 IND and NDA
15 Clinical Data Management
16 Safety Reporting and Pharmacoviligance
17 Quality Assurance in Clinical Research
18 Standard Operating Procedures
19 Clinical Research Outsourcing
20 Statistics in Clinical Research
21 Insurance and Liability
22 Non-compliance
23 Misconduct and Fraud
24 Intellectual Property Rights
25 Websites for Information
– Appendices.