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2023-07-12T05:25:54
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Abbreviated terms and definitionsA list of abbreviated terms and definitions of specialized or unusual terms

Abbreviated terms and definitions A list of abbreviated terms and definitions of specialized or unusual terms should be provided. 10. List of appendices to the clinical investigation report (a) Protocols and amendments; (b) Specimen of Case Record Form; (c) Investigators' name(s) with contact addresses, phone, e-mail etc.; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (d) Patient data listings (e) List of participants treated with investigational product; (e) Discontinued participants; (f) Protocol deviations; (g) CRFs of cases involving death and life threatening adverse event cases; (h) Publications from the investigation; (i) Important publications referenced in the clinical investigation; (j) Audit certificate, if available; (k)List of other parties involved (e.g. core labs, contract research organizations (CROs), experts, etc.); (1) List of monitors involved; (m) Investigator's certificate that he or she has read the report and that the report accurately describes the conduct and the results of the clinical investigation.

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