New discussion: PhV in medical research - XXI

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Dear members,Minimum criteria for reportingInformation for final description and evaluation of a case report may not be available within the required time frames for reporting.Nevertheless, for regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: - An identifiable patient; - A suspect medicinal product; - An identifiable reporting source; and - An event or outcome that

can be identified as serious and unexpected, and for which there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available. Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060