Indian draft guidelines for clinical trial compensation for medical management

10 June 2014

India's Ministry of Health has released new and revised draft guidelines on compensation to be paid for medical management with regards to treatment of any injury related to clinical trial is now aligned with global standards, reports Max Neeman International, a full service contract research organization with Southeast Asia expertise.

The new guidelines on medical management in clinical trial injury states that:

In the case of an injury occurring to the subject during the clinical trial, free medical management will be given as long as required or till such time it is established that the injury is not related to the clinical trial.
The sponsor shall pay compensation for the treatment of any injuries or deaths suffered by trial subjects if proven as trial-related. No compensation should be paid for the failure of the medicinal product to have its intended effect or to provide any other benefit to the patient.
Injury or death in the placebo-treated arm of a trial is eligible for compensation only if the standard care, though available, was not provided to the subject per the clinical trial protocol.

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