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

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Guidance for Industry Central Drugs Standard Control Organization Page 22   SECTION D: PROPOSED PHASE-III STUDIES (Compliance as per Schedule Y)   1. Protocol for Phase-III studies References: 1. Schedule – Y, Amendment version 2005, Drugs and Cosmetics Rules, 1945. 2. GCP guidelines published by CDSCO, DGHS, Govt. of India. 3. Ethical Guidelines for Biomedical Research on Human Subjects published by Indian Council of Medical Research, New Delhi.
Guidance for Industry Central Drugs Standard Control Organization Page 23   OTHER REQUIREMENTS (SCHEDULE Y): Part 1: Contents of the proposed protocol for conducting Clinical Trials   1. Title Page: a. Full title of the clinical study. b. Protocol/Study number and protocol version number with date. c. The IND name/number of the investigational drug. d. Complete name and address of the sponsor and contract research organization, if any. e. List of the Investigators who are conducting the study, their respective institutional affiliations and site locations. f. Name(s) of clinical laboratories and other departments and/or facilities participating in the study. 2. Table of contents: A complete Table of Contents including a list of all Appendices 1. Background and Introduction a. Pre-clinical experience b. Clinical experience previous clinical work with the new drug should be reviewed here and a description of how the current protocol extends existing data should be provided. If this is an entirely new indication, how this drug was considered for this should be discussed. Relevant information regarding pharmacological, toxicological and other biological properties of the drug/biological/medical device and previous efficacy and safety experience should be described. 2. Study Rationale
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  © Central Drugs Standard Contr
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