. Study subject care
. Source document
. Corroborating/supporting document – the medical record is generally a document with some legal
status, open to degrees of peer review, and completed in many cases by several people. As such
it serves as an important supporting document to corroborate data reported to the sponsor in the
CRF.
. For example identity and patient existence, demographics, medical history, diagnosis, participation
in the clinical trial, IMP and concomitant medication, intercurrent illness and adverse events. In
addition, various protocol related measurements may appear here or in related documents
(laboratory reports, ECGs, X-rays and reports etc).
. Where the protocol has described that certain data may be recorded solely in the CRF – this in
general is taken to mean multiple repeat measurements, rating scales, study subject diaries.
