ICH E6(R3) – All those planned and systematic actions that are established to ensure that the trial is performed, and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirement(s).
CDISC-Gloss – All those planned and systematic actions that are established to ensure that the trial is performed, and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH E6 R2 Glossary]