Electronic Source Report Form

CDISC-Gloss – The human-readable rendering of an electronic record serving as an eSource document that is part of a case history. The eSRF supports capture, transmission, storage, editing and/ or display of eSource documents (original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation) used for reconstructing and evaluating the investigation. NOTE: Intended use distinguishes eCRF and eSRF. The eCRF is for capture, review and editing of protocol data belonging to the sponsor; the eSRF is for the human-readable representation of the eSource document for review or to maintain the eSource document that is part of the case history under 21CFR312.62. See also eCRF, eSource document. [CDISC, relevant to FDA Final Guidance on eSource]