2023-07-11T06:00:29
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.
Have a question? Ask here!
Required fields are marked *