Table of ContentsM
* Clinical Research?Past, Present and Future
* Drug Development and Discovery
* Designing Clinical Trials
* Ethical Issues in Clinical Research
* ICH-GCP Guidelines
* Informed Consent Process: Protecting Subjects Rights
* Role of CRC and CRA in Clinical Trials
* Protocol Designing
* Sponsor?s and Investigator?s Responsibilities
* Patient Recruitment and Retention in Clinical Trials
* Project Management in Clinical Trials
* Pharmacovigilance in Clinical Research
* Role of Contract Research Organization in Clinical Research Management
* Outsourcing Clinical Research
* Biostatistics in Clinical Trials
* Bioequivalence Studies in Drug Development
* Finance and Budgeting in Clinical Trials
* Clinical Data Management
* Clinical Trials for Herbal Drugs and Traditional Medicines
* Investigational New Drug Applications
* Case Report Form
* Clinical Trial Logs
* Standard Operating Procedures
* Audits and Inspections in Clinical Trials
* Fraud and Misconduct in Clinical Research
* An Introduction to Medical Writing
* Communication Skills
* Requirements and Guidelines to Undertake Clinical Trials in India Schedule Y (Amended Version)
* APPENDIX I: Data to be Submitted along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in the Country
* APPENDIX I-A: Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in the Country
* Index