CDSCO - Guidance for Industry - Central Drugs Standard Control ...

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Guidance for Industry Central Drugs Standard Control Organization Page 28     15. Undertaking by the Investigator (as per the Appendix VII of Schedule Y) 16. Appendices: Provide a study synopsis, copies of the informed consent documents (patient information sheet, informed consent form etc.); CRF and other data collection forms; a summary of relevant pre-clinical safety information and any other documents referenced in the clinical protocol.
Guidance for Industry Central Drugs Standard Control Organization Page 29   Part 2: Appendix XI to Schedule Y Data elements for reporting Serious Adverse events occurring in Clinical Trial   1. Patients Details- Initials and other relevant identifier (hospital/OPD record number etc) Gender Age and/or date of birth Weight Height 2. Suspected Drug(s)- Generic name of the drug Indication(s) for which suspected drug was prescribed or tested Dosage form and strength Daily dose and regimen (specify units e.g.-mg, ml, mg/kg) Route of administration Starting date and time of day Stopping date and time or duration of treatment 3. Other Treatment(s)- Provide the same information for concomitant drugs (including non-prescription/OTC drugs) and non-drug therapies, as for the suspected drug (s). 4. Details of Suspected Adverse Drug Reaction(s)- Full description of reaction(s) including body site and severity as well as the criterion (or criteria) for regarding the report as
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  © Central Drugs Standard Contr
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