Types of Case Report Forms The following is a sugg...

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).