CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies the content of a clinical investigation plan (hereinafter to be referred as CIP). If the required information is written in other documentation, for example the IB, such documentation shall be referenced in the CIP. The content of a CIP and any subsequent amendments shall include all the topics listed in this document, together with a justification for each topic if this is not self-explanatory. 1.1.2 Identification of the clinical investigation plan (a) Title of the clinical investigation. (b) Reference number identifying the specific clinical investigation, if any. (c) Version or date of the CIP. (d) Summary of the revision history in the case of amendments. (e) Version or issue number and reference number, if any, with the page number and the total number of pages on each page of the CIP. 1.1.3 Sponsor Name, address and contact details (e-mail id, phone number, etc.) of the sponsor of the clinical investigation. 1.1.4 Principal investigator, coordinating investigator and investigation site Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 181 of 248 (a) Name, address, and professional position of— (i) Principal Investigator, (ii) Coordinating investigator, if appointed. (b) Name and address of the investigation site in which the clinical investigation will be conducted. (c) Name and address of other institutions involved in the clinical investigation. The sponsor shall maintain an updated list of principal investigators, investigation sites, and institutions.