Posted by cheri on Nov 13, 2023 in Regulatory matters
Patient Safety is described in the Code of Federal Regulation in 21CFR50 while the ICH GCP §6 (R2) is found in Sections 1.26, 1.27, 1.28, 1.31., 1.37., 1.61., 2.9., 3.1.2., 3.1.6., 3.1.7., 3.1.9., 4.4.1., 4.8., 5.0.2., 5.11.1., 5.11.2., 5.15.2., 5.18.2. Collection of ICF is found in Section 8.2.3.