Essentials of Clinical Research
Language: English
Published by Nirali Prakshan, 2010
- Softcover
- New

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- Title
- Essentials of Clinical Research
- Author
- Dr. Ravinder Ghooi; Mr. Sachin Itkar
- Publisher
- Nirali Prakshan
- Publication year
- 2010
- Condition
- New
- Binding
- Soft cover
- Language
- English
- ISBN 10
- 9380725094
- ISBN 13
- 9789380725093
Introduction,Drug Development Process, Clinical Trials on drugs, Regulatory control over drugs, Ethical aspects of Clinical Research, Responsibility of Stakeholders, Clinical Trial Documents, Endpoints in Clinical Research, Site and Investigators Selection, Subject Recruitment and selection, Meetings in Clinical Research, Data and safety monitoring, IND and NDA, Clinical Data Management, Safety reporting and pharmacovigilance Quality Assurance in Clinical Research,Standard Operating Procedures, Clinical Research outsourcing Statistics in Clinical Research, Insurance and Liability, Non-compliance misconduct and Fraud, Intellectual Property Rights websites for information
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