Regulations of Clinical Trials
Contents:
Regulation of Clinical Trials in India : An Introduction
Revised Schedule Y of Drugs and Cosmetics Rules
Rule 122 of Drugs and Cosmetics Act
Application Format for Undertaking Clinical Trial in India
Format for Fees Submission
Conditions for Import of Drugs for Examination, Test or Analysis
Conditions for Manufacture of Drugs for Examination, Test or Analysis
Stocking of Drugs
Indian GCP Guidelines
Guidelines for Bioavailability & Bioequivalence Studies
ICH Harmonised Tripartite Guideline -
Guideline for Good Clinical Practice - E6(R1)
Data Safety Monitoring Board
Registrations of Clinical Trials
The Nuremberg Code
The Belmont Report
Clinical Research Organisations in India
