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- Title
Regulatory changes in conduct of clinical trials: A need for review.
- Authors
Chatterjee, Suparna
- Abstract
The author reflects on the need for review of the regulatory changes in the clinical trials conduct in India. The author mentions that the salient notifications from the Central Drugs Standard Control Organization (CDSCO) include the serious adverse event (SAE) definition and compensation in case of injury or death during the clinical trials. The author states that stakeholders of clinical trials can benefit through the modification of some of the clauses of the rule 122 DAB.
- Subjects
INDIA; CLINICAL trials; CENTRAL Drugs Standard Control Organization; ADVERSE health care events; STAKEHOLDERS
- Publication
Indian Journal of Pharmacology, 2013, Vol 45, Issue 4, p323
- ISSN
0253-7613
- Publication type
Editorial
- DOI
10.4103/0253-7613.114990