Regulatory Draft Guidelines Address Clinical Trial Compensation for Medical Management in India - WAFF-TV: News, Weather and Sports for Huntsville, AL

Regulatory Draft Guidelines Address Clinical Trial Compensation for Medical Management in India

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SOURCE Max Neeman International

RESEARCH TRIANGLE PARK, N.C., June 9, 2014 /PRNewswire/ -- Max Neeman International announced today that India's Ministry of Health 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.

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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.

The new amendments will enhance the safety of subjects and ensure adequate care is taken in the event of an injury in clinical trial.

About Max Neeman International
Max Neeman International is a full service CRO with S.E. Asia expertise. Our specialty is that we offer services for the successful conduct of clinical trials for small and mid-sized drug/device and nutraceutical companies in compliance with ICH GCP standards. Max Neeman is ISO certified for Monitoring, Site Management and Data Management Services. Please contact: Ann Vawter - Director, Business & Marketing Max Neeman International P: 919.424.3332 / F: 919.852.5574 Email: ann.vawter@neeman-medical.com

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