Procedural issues A system shall be established t...

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. TABLE 7 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.