Clinical Trials: Comparative Study Of Guidelines In Europe and India

This book is based on Clinical Trial Regulation in Europe and India. Comparison is done on the basis of different parameters such as regulatory bodies involved, regulations for CTs, clinical trial application format, application fee, approval time, the various forms required, role and responsibilities of IRB/IEC, record retention time, and GCP guidelines. The success rate of CTs in Europe is higher in comparison to India, which may be due to well-trained investigators, fast regulatory approval process and volunteer participation by the subjects.