CDISC-Gloss – Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol.
CDISC-Gloss – Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol.