RESOURCES
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