If the study is an investigator-initiated, multicenter study, have all investigative sites been properly notified of ICH GCP E6: 8.3.18 relevant safety information? Have changes in facilities been documented ICH GCP E6:.2.3, 4.9.4, 5.18.4(b) appropriately? 21 CFR: 812.35(b) Is the ClinicalTrials.gov record up to date? Is there reason to believe that the Investigator has, and ICH GCP E6: 4.2.4, 4.3 is continuing to provide appropriate oversight of the 21 CFR: 312.53 (c)(1)(vi)(c), 312.60, 812.43, 812.100, study and/or study team? 812.110(b)(c)
If the study is an investigator-initiated, multicenter study, have all investigative sites been properly notified of relevant safety information? ICH GCP E6: 8.3.18 Have changes in facilities been documented appropriately? ICH GCP E6:.2.3, 4.9.4, 5.18.4(b) 21 CFR: 812.35(b) Is the ClinicalTrials.gov record up to date? Is there reason to believe that the Investigator has, and is continuing to provide appropriate oversight of the study and/or study team? ICH GCP E6: 4.2.4, 4.3 21 CFR: 312.53 (c)(1)(vi)(c), 312.60, 812.43, 812.100, 812.110(b)(c)
Self-AuditToolRegulatoryFileReview-2016_11_11_clean.docx