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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.

Produktbeschreibung
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.
Autorenporträt
O Dr. Vijay Kumar trabalha actualmente como Professor no Departamento de Dentisteria Conservadora e Endodontia no Himachal Dental College, Sundernagar, Índia. Ele tem muitas Publicações em seu nome e está envolvido em académicos com esforços sinceros dos últimos 19 anos.