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documentation archive 10322 disk0/00/00/03/30 2016-07-07 13:06:16 2025-04-29 13:34:18 2016-07-08 13:35:27 data_collection show Inglis Louise 8125 glaresearchdata:2016-07-07-330 25200000 The Entracte study (protocol number WA25204) was a 5-year Rheumatology Study. The study object was to compare prospectively two rheumatology drugs (TCZ and Etanercept) with respect to drug efficacy and the time to first occurrence of any component of a composite of major adverse cardiovascular events. Subjects randomised into the study who completed the full 5-year clinical trial had multiple ECGs recorded over that period. The remit of the University of Glasgow ECG core lab team based at Glasgow Royal Infirmary was to ensure accurate, quality ECG data collection to facilitate the identification of a potential silent myocardial infarction (MI) in study subjects. The check for potential silent MIs was carried out by Professor Peter Macfarlane. ECGs with a potential silent MI were subsequently forwarded to the Cardiovascular Endpoint Event Adjudication Committee who made the final decision on the basis of the ECG and the subject’s clinical history. The paper ECG data for this study is archived at Roche in Basel, Switzerland with a 10-year retention period. 2016-07-07 University of Glasgow none Paper_Records Spreadsheet Roche 58644 ECG Services for project - MOA61163 Roche PDO CV outcomes for Acterma RA "Entracte" Peter Macfarlane Hoffmann-La Roche Ltd Roche Electrocardiology Group, Institute of Cardiovascular and Medical Sciences FALSE EN 2011-04-14 2016-05-16 2011-04-14 2016-05-16 2026-05-31 D-con Paper records to be destroyed by Roche in Switzerland. TRUE Details of ethics approval in the 31 countries involved in the study is in the Excel spreadsheet stored with this electronic record. FALSE