Procedural issues A system shall be established to enable cross-referencing of CRFs and CIP versions. Supplemental CRFs may be developed for collecting additional data at individual investigation sites in multicenter investigations. DATA ELEMENTS FOR REPORTING SERIOUS ADVERSE EVENTS OCCURRING IN A CLINICAL INVESTIGATION 1. Patient details: (a) Initials and other relevant identifier (hospital/Out Patient Department's record number etc.); (b) Gender; (c) Age and date of birth; (d) Weight; (e) Fleight. 2. Suspected device(s): (a) Name of the Device; (b) Indication(s) for which suspect device was prescribed; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 190 of 248 (c) Device details including model number / size / lot number, if applicable; (d) Starting date and time of day; (e) Stopping date and time, or duration of treatment; 3. Other treatment(s): Provide the same information for concomitant treatment. 4. Details of suspected adverse device reaction(s): (a) Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious. In addition to a description of the reported signs and symptoms, whenever possible, describe a specific diagnosis for the reaction. (b) Start date (and time) of onset of reaction. (c) Stop date (and time) or duration of reaction. (d) Setting (e.g., hospital, out-patient clinic, home, nursing home). 5. Outcome: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have been conducted. (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any post-mortem findings. (c) Other information: Anything relevant to facilitate assessment of the case, such as medical history including allergy, drug or alcohol abuse; family history; findings from special investigations etc. 6. Details about the Investigator: (a) Name; (b) Address; (c) Telephone number; (d) Profession (specialty); (e) Date of reporting the event to Central Licensing Authority; (f) Date of reporting the event to Ethics Committee overseeing the site; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 191 of 248 (g) Signature of the Investigator.