Transcription of DRAFT GUIDANCE FOR INDUSTRY ON REPORTING …
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DRAFT GUIDANCE FOR INDUSTRY ON REPORTING …
Dated:11-05-2011 DRAFT GUIDELINES ON REPORTING SERIOUS ADVERSE EVENTS Page 1 of 9 GUIDELINES ON REPORTING SERIOUS ADVERSE EVENT DRAFT GUIDANCE FOR INDUSTRY ON REPORTING SERIOUS ADVERSE EVENTS OCCURING IN CLINICAL TRIALS Suggestion/comments on the GUIDANCE documents if any may please be forwarded to CDSCO within fifteen days Drugs Controller General (India) Directorate General of Health Services Central Drugs Standard Control Organization New Delhi Dated:11-05-2011 DRAFT GUIDELINES ON REPORTING SERIOUS ADVERSE EVENTS Page 2 of 9 1 ABBREVIATIONS AND DEFINITIONS ABBREVIATIONS AE Adverse Event BE Bioequivalence CDSCO Central Drugs Standard Control Organization CRO Contract Research Organization CT Clinical Trial DCGI Drugs Controller General (India) DGHS Directorate General of Health Services IND Investigational New Drug NCE New Chemical Entity SAE Serious Adverse Event DEFINITIONS Adverse Event (AE) Any untoward medical occurrence (including a symptom / disease or an abnormal laboratory finding) du
draft guidelines on reporting serious adverse events dated:11-05-2011 page 1 of 9 guidelines on reporting serious adverse event draft guidance for industry on reporting serious adverse events
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