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Category: Compensation

Injury and death in clinical trials and compensation: Rule 122 DAB

  By admin Archives, Clinical Trials, Compensation

Ghoul R. B. | Perspectives in Clinical Research | PubMed Central (PMC) | NCBI | Oct 2013 Three amendments to the drugs and cosmetics rules were published in quick succession in 2013. These addressed the issues of compensation of injury and death… Continue reading

India’s regulatory reforms on compensation for clinical trial injuries and deaths: urgent need for revisiting

  By admin Archives, Clinical Trials, Compensation

Jerome Amir Singh | Indian Journal of Medical Research | Vol 10 No 3 | 2013 Financial compensation to participants in clinical trials for the immediate and long-term medical treatment of injuries sustained while participating in the trials, and payment… Continue reading

New rules for clinical trial-related injury and compensation

  By admin Archives, Clinical Trials, Compensation

Khushboo Choudhury, Ravindra Ghooi | Indian Journal of Medical Ethics | Vol 10, No 3 | 2013 Abstract The rules for compensation for injury and death in clinical trials have recently been notified. These rules clarify that medical management of all injuries… Continue reading

New regulations on compensation for injury and death in drug trials

  By admin Archives, Clinical Trials, Compensation

Amar Jesani | Indian Journal of Medical Ethics | Vol 10, No 2 | Apr-Jun 2013 In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials… Continue reading

New regulations on compensation for injury and death in drug trials

  By admin Archives, Clinical Trials, Compensation

Amar Jesani | Indian Journal of Medical Ethics | Vol 10 No 2 | 2013 In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials… Continue reading

Compensation for research related injury

  By admin Archives, Clinical Trials, Compensation

Renuka Munshi, Urmila Thatte | Perspectives in Clinical Research | v.4(1) | Jan-Mar 2013 | Source: NCBI-PMC In March 2006, eight healthy volunteers in a phase I trial received a T cell agonist at Parexel’s clinical pharmacology research unit at… Continue reading

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