Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study
Alyson Takaoka, Nicole Zytaruk, Megan Davis, Andrea Matte, Jennie Johnstone, François Lauzier, John Marshall, Neill Adhikari, France J Clarke, Bram Rochwerg, François Lamontagne, Lori Hand, Irene Watpool, Rebecca K Porteous, Marie-Hélène Masse, Frédérick D'Aragon, Daniel Niven, Diane Heels-Ansdell, Erick Duan, Joanna Dionne, Shane English, Charles St-Arnaud, Tina Millen, Deborah J Cook, PROSPECT Investigators and the Canadian Critical Care Trials Group, Alyson Takaoka, Nicole Zytaruk, Megan Davis, Andrea Matte, Jennie Johnstone, François Lauzier, John Marshall, Neill Adhikari, France J Clarke, Bram Rochwerg, François Lamontagne, Lori Hand, Irene Watpool, Rebecca K Porteous, Marie-Hélène Masse, Frédérick D'Aragon, Daniel Niven, Diane Heels-Ansdell, Erick Duan, Joanna Dionne, Shane English, Charles St-Arnaud, Tina Millen, Deborah J Cook, PROSPECT Investigators and the Canadian Critical Care Trials Group
Abstract
Purpose: To categorize, quantify and interpret findings documented in feedback letters of monitoring or auditing visits for an investigator-initiated, peer-review funded multicenter randomized trial testing probiotics for critically ill patients.
Materials & methods: In 37 Canadian centers, monitoring and auditing visits were performed by 3 trained individuals; findings were reported in feedback letters. At trial termination, we performed duplicate content analysis on letters, categorizing observations first into unique findings, followed by 10 pre-determined trial quality management domains. We further classified each observation into a) missing operational records, b) errors in process, and potential threats to c) data integrity, d) patient privacy or e) safety.
Results: Across 37 monitoring or auditing visits, 75 unique findings were categorized into 10 domains. Most frequently, observations were in domains of training documentation (180/566 [32%]) and the informed consent process (133/566 [23%]). Most observations were missing operational records (438/566 [77%]) rather than errors in process (128/566 [23%]). Of 75 findings, 13 (62/566 observations [11%]) posed a potential threat to data integrity, 1 (1/566 observation [0.18%]) to patient privacy, and 9 (49/566 observations [8.7%]) to patient safety.
Conclusions: Monitoring and auditing findings predominantly concerned missing documentation with minimal threats to data integrity, patient privacy or safety.
Trial registration: PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial): NCT02462590.
Keywords: Audit; Critical illness; Good clinical practice; Monitor; Randomized trial.
Conflict of interest statement
Declaration of Competing Interest Dr. F D'Aragon is a recipient of a Research Career Award from the Fonds de la recherche du Québec-Santé. Dr. S English holds a National New Investigator award from the Heart and Stroke Foundation. Dr. D Cook holds a Canada Research Chair in Knowledge Translation in Critical Care.
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed