We have provided some of the reference documents and useful links, which are useful in the execution of clinical trials.

Downloads

• ICH E6(R2) Good Clinical Practice (GCP)
• Good Clinical Practice (GCP) published by CDSCO
• The New drugs and Clinical trials rules 2019
• National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
• WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Useful links

• Central Drugs Standard Control Organization
• Indian Council of Medical Research
• Sugam
• Consultancy Services for Bioequivalence and Bioavailability Studies
• European Medical Writers Association
• American Medical Writers Association
• FDA-Approved Drugs
• European electronic medicines compendium (emc)
• WHO Technical Report Series