Table of Contents

Clinical Trial Regulation in India: Recent Updates

Clinical Trial Regulation in India: Recent Updates

The Central Drugs Standard Control Organization (CDSCO) in India has issued number of guidelines to strengthen clinical trial regulations in India after January 2013. We have tried to compile these guideline in this mailer to have overall understanding on the same.

The recent amendments in schedule Y are

Audio-Visual Recording of Consent

Dr Ranjit Roy Chaudhary Report

SAE Reporting and Compensation

The process of SAEs reporting in case of injury/death has been revised in recent Schedule Y amendments and below is required information to be submitted along with the SAEs report.

Ethics Committee Registration

Pre-screening Checklist for Clinical Trial and New Drugs Applications

On behalf of “People for the Advancement of Clinical Research – India”, who have taken the initiative to revive the Clinical Research conduct in India, we would like to request all the Clinical Research Professionals to read the petition, and if you agree with the cause, please sign the petition here

Recent Circular related to clinical trials

Articles on recent regulation for detail reading

We would also like to update our subscribers on the followings

  1. After conducting three successful events on recent clinical trial regulation we have created a group “Clinical Research Events in India”. Click here to join the group
  2. Telecast of our recent conference On Adapting to the Current Regulatory Challenges in conduct of Clinical Research  Focus on Sites and Ethics Committees can be viewed on CARE WORLD TV on following timings -27th Nov’13 Wednesday @ 10:45 hrs, 29th Nov’13 Friday@ 14:50 hrs, 1st Dec’13 Sunday@ 20:17 hrs. To Watch Care World Live:
  3. Our training partner SenseCR has organized a workshop titled as “Case study based advanced GCP Workshop” on 29th Nov, 2013 at Bawa International Hotel, Near Domestic Airport, Mumbai. Please contact Shilpa Garg at [email protected]

To Subscribe to our Newsletter – Please Click here

Enter the Captcha