Publication policy (a) Statement indicating whether the results of the clinical investigation will be submitted for publication. (b) Statement indicating the conditions under which the results of the clirical investigation will be offered for publication. TABLE 6 CASE REPORT FORM (CRF) 1. General (i) Case Report Forms are established to implement the clinical investigation plan, to facilitate subject observation and to record subject and investigational medical device data during the clinical investigation according to the clinical investigation plan. They can exist as printed, optical, or electronic documents and can be organized into a separate section for each subject.(ii) The Case Report Forms should reflect the clinical investigation plan and take account of the nature of the investigational medical device. 2. Content and format Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 188 of 248 2.1 Overall considerations (i) The Case Report Forms can be organized such that they reflect all the data from a single procedure or a single visit or other grouping that makes clinical or chronological sense. (ii) The format of Case Report Forms shall be such as to minimize errors that can be made by those who enter data and those who transcribe the data into other systems. (iii) The data categories and format listed in this Table can be considered when designing a Case Report Form. 2.2 Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investigation plan version and date (if required). (3) Version number of Case Report Forms. (4) Name of clinical investigation or reference number (if applicable). 2.3 Header or footer or Case Report Form identifier (a) Name of the clinical investigation or reference number. (b) Version number of Case Report Forms. (c) Investigation site / principal investigator identification number. (d) Subject identification number and additional identification such as date of birth or initials, if allowed by national regulations. (e) Case Report Form number or date of visit or visit number. (f) Page / screen number of CRF and total number of pages / screens (e.g. "page x of xx"). 2.4 Types of Case Report Forms The following is a suggested list of CRFs that may be developed to support a clinical investigation. This is not an exhaustive list and is intended to be used as a guideline. (a) Screening. (b) Documentation of subject's informed consent. (c) Inclusion/exclusion. (d) Baseline visit: (1) demographics; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 189 of 248 (2) medical diagnosis; (3) relevant previous medications or procedures; (4) date of enrolment; (5) other characteristics. (e) Intervention(s) or treatment(s). (f) Follow-up visit(s). (g) Clinical investigation procedure(s). (h) Adverse event(s). (i) Device deficiencies. (j) Concomitant illness(es) / medication(s). (k) Unscheduled visit(s). (1) Subject diary. (m) Subject withdrawal or lost to follow-up. (n) Form signifying the end of the clinical investigation, signed by the principal investigator or his/her authorised designee. (o) CIP deviation(s).