New Rules on Compensation_Rule 122 DAB_6th Amendment

[Reena Wadhwani]

Dear All,

Rule 122 DAB has been revised and is effective from 12-Jun-2015.

Following are the revisions to the rule:

1. In case of any injury occurring to the subject during the clinical trial, free medical management shall be provided to patients as long as required.

Revision: In case of any injury occurring to the subject during the clinical trial, free medical management shall be provided to patients as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.

2. In case of SAE, The Investigator after due analysis of the report should report a Follow-up SAE within 10 days of the SAE occurrence to Licensing Authority, Sponsor & Head of Institution.

Revision: The reporting timelines have been changed from 10 to 14 days.

3. In case of SAE, the Ethics Committee after due analysis along with its opinion on financial compensation shall forward its report to Licensing Authority within 21 days of the occurrence of the event.

Revision: Reporting timelines have been changed from 21 to 30 days.

4. Research injury  - the following changes have been done. Other criteria remain the same:

- Use of placebo in a "placebo controlled trial" where the standard of care though available was not provided to the subject as per the clinical trial protocol.

5. Failure of IP to provide intended therapeutic effect where the standard of care though available was not provided to the subject as per the clinical trial protocol.

The gazette has been attached for your reference.

Kindly let us know if you have any questions.

Regards

Reena Wadhwani

QA Associate

JCDC