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- B6319d9059c5ed40fe118b0a9cf035d73 NCIT_P378 "CDISC-GLOSS" @default.
- B6319d9059c5ed40fe118b0a9cf035d73 type Axiom @default.
- B6319d9059c5ed40fe118b0a9cf035d73 annotatedProperty NCIT_P325 @default.
- B6319d9059c5ed40fe118b0a9cf035d73 annotatedSource NCIT_C142534 @default.
- B6319d9059c5ed40fe118b0a9cf035d73 annotatedTarget "Source data captured initially into a permanent electronic record (eSource document) used for the reconstruction and evaluation of a clinical study or a source data item included in an eCRF when direct entry is made. NOTE: permanent in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail. See also eSource document, source data, permanent data, data originator. [From body of FDA Final Guidance on eSource]" @default.