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Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL …
WebGood Clinical Practice Inspectors Working Group (GCP IWG)3 4 Guideline on computerised systems and electronic data in 5 clinical trials ... (ICH-GCP 1.11) 157 Certified copy 158 “A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a WebICH GCP - Records and reports Records and reports This section refers to the section 4.9 of the INTEGRATED ADDENDUM TO ICH E6 (R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6 (R2), including Addenda items. It provides an overview of the requirements to the trial records management and maintenance, as well as storage, and … dauther of the emperor
Quality Corner: Valid Source Documents and Certified Copies
WebAll information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the … WebCertified Copies Cloud Based Software Electronic Data Capture Electronic Records Electronic Services IRB Mobile Technology Printed Copies Scanning Signatures Source Files Storage of Files Trial Master Files Validation Other Topics Go Home WebA certified copy is a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the … black and berry ventures llc