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.