{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T12:00:57Z","timestamp":1790683257207,"version":"4.1.0"},"reference-count":29,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2021,5]]},"DOI":"10.1016\/j.cct.2021.106368","type":"journal-article","created":{"date-parts":[[2021,3,26]],"date-time":"2021-03-26T19:59:22Z","timestamp":1616788762000},"page":"106368","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":13,"special_numbering":"C","title":["Risk-based centralized data monitoring of clinical trials at the time of COVID-19 pandemic"],"prefix":"10.1016","volume":"104","author":[{"given":"Most Alina","family":"Afroz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grant","family":"Schwarber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad Alfrad Nobel","family":"Bhuiyan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cct.2021.106368_bb0005","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1177\/1740774507087554","article-title":"Ensuring trial validity by data quality assurance and diversification of monitoring methods","volume":"5","author":"Baigent","year":"2008","journal-title":"Clinical Trials"},{"issue":"2","key":"10.1016\/j.cct.2021.106368_bb0010","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1177\/1740774511427325","article-title":"The potential for central monitoring techniques to replace on-site monitoring: findings from an international multicenter clinical trial","volume":"9","author":"Bakobaki","year":"2012","journal-title":"Clinical Trials"},{"issue":"11","key":"10.1016\/j.cct.2021.106368_bb0015","article-title":"The basics of clinical trial centralized monitoring","volume":"27","author":"Beauregard","year":"2018","journal-title":"Appl. Clin. Trials"},{"issue":"24","key":"10.1016\/j.cct.2021.106368_bb0020","doi-asserted-by":"crossref","first-page":"3435","DOI":"10.1002\/(SICI)1097-0258(19991230)18:24<3435::AID-SIM365>3.0.CO;2-O","article-title":"The role of biostatistics in the prevention, detection, and treatment of fraud in clinical trials","volume":"18","author":"Buyse","year":"1999","journal-title":"Stat. Med."},{"issue":"4","key":"10.1016\/j.cct.2021.106368_bb0025","first-page":"44","article-title":"Using excel and \u2019\u2018Benford\u2019s law to detect fraud: learn the formulas, functions, and techniques that enable efficient benford analysis of data sets","volume":"223","author":"Collins","year":"2017","journal-title":"J. Account."},{"key":"10.1016\/j.cct.2021.106368_bb0030","series-title":"The Mahalanobis Distance, Chemometrics, and Intelligent Laboratory Systems","author":"De Maesschalck","year":"2000"},{"issue":"7","key":"10.1016\/j.cct.2021.106368_bb0035","doi-asserted-by":"crossref","first-page":"1204","DOI":"10.1016\/j.clinthera.2018.04.020","article-title":"Risk-based monitoring of clinical trials: an integrative approach","volume":"40","author":"Agrafiotis","year":"2018","journal-title":"Clin. Ther."},{"issue":"3","key":"10.1016\/j.cct.2021.106368_bb0040","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1007\/s11634-009-0048-5","article-title":"The value of the last digit: statistical fraud detection with digit analysis","volume":"3","author":"Dlugosz","year":"2009","journal-title":"ADAC"},{"key":"10.1016\/j.cct.2021.106368_bb0045","first-page":"1","article-title":"Reflection paper on risk-based quality management in clinical trials","volume":"44","author":"European Medicines Agency","year":"2013","journal-title":"Compliance Insp"},{"key":"10.1016\/j.cct.2021.106368_bb0050","series-title":"Fraud and Misconduct in Medical Research","first-page":"186","article-title":"Statistical aspects of the detection of fraud","author":"Evans","year":"2001"},{"key":"10.1016\/j.cct.2021.106368_bb0055","series-title":"Guidance for Industry: Oversight of Clinical Investigations\u2014A Risk-Based Approach to Monitoring","author":"Food and Drug Administration","year":"2013"},{"key":"10.1016\/j.cct.2021.106368_bb0060","author":"Food and Drug Administration"},{"issue":"2","key":"10.1016\/j.cct.2021.106368_bb0065","doi-asserted-by":"crossref","first-page":"161","DOI":"10.4155\/cli.14.116","article-title":"Data fraud in clinical trials","volume":"5","author":"George","year":"2015","journal-title":"Clin. Investig. (Lond)."},{"key":"10.1016\/j.cct.2021.106368_bb0070","series-title":"Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2)","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use","year":"2016"},{"issue":"5","key":"10.1016\/j.cct.2021.106368_bb0075","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1177\/1740774513494504","article-title":"Application of methods for central statistical monitoring in clinical trials","volume":"10","author":"Kirkwood","year":"2013","journal-title":"Clin. Trials"},{"issue":"4","key":"10.1016\/j.cct.2021.106368_bb0080","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1177\/002581729606400403","article-title":"Fraud and misconduct in medical research","volume":"64","author":"Lock","year":"1996","journal-title":"Med. Leg. J."},{"issue":"3","key":"10.1016\/j.cct.2021.106368_bb0085","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1177\/1740774511402703","article-title":"Monitoring the quality of conduct of clinical trials: a survey of current practices","volume":"8","author":"Morrison","year":"2011","journal-title":"Clin. Trials"},{"issue":"2","key":"10.1016\/j.cct.2021.106368_bb0090","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1152\/jappl.1993.74.2.617","article-title":"Influence of respiration on heart rate and blood pressure fluctuations","volume":"74","author":"Novak","year":"1993","journal-title":"J. Appl. Physiol."},{"issue":"1","key":"10.1016\/j.cct.2021.106368_bb0095","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1007\/s10147-015-0914-4","article-title":"Statistical challenges for central monitoring in clinical trials: a review","volume":"21","author":"Oba","year":"2016","journal-title":"Int. J. Clin. Oncol."},{"issue":"2","key":"10.1016\/j.cct.2021.106368_bb0100","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1177\/1740774515625964","article-title":"Key cost drivers of pharmaceutical clinical trials in the United States","volume":"13","author":"Sertkaya","year":"2016","journal-title":"Clin. Trials"},{"key":"10.1016\/j.cct.2021.106368_bb0105","series-title":"The Current Status of Risk-Based Monitoring","author":"Sullivan","year":"2015"},{"issue":"6","key":"10.1016\/j.cct.2021.106368_bb0110","doi-asserted-by":"crossref","first-page":"745","DOI":"10.1177\/009286151004400611","article-title":"Risk-based source data verification approaches pros and cons","volume":"44","author":"Tantsyura","year":"2010","journal-title":"Drug Inf. J.: D.I.J.\/Drug Inf. Assoc."},{"issue":"19","key":"10.1016\/j.cct.2021.106368_bb0115","doi-asserted-by":"crossref","first-page":"2939","DOI":"10.1002\/sim.1298","article-title":"Policy developments in regulatory approval","volume":"21","author":"Temple","year":"2002","journal-title":"Stat. Med."},{"key":"10.1016\/j.cct.2021.106368_bb0120","series-title":"Position Paper: Risk-Based Monitoring Methodology","author":"TransCelerate BioPharma Inc.","year":"2013"},{"issue":"1","key":"10.1016\/j.cct.2021.106368_bb0125","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1007\/s10120-015-0533-9","article-title":"Statistical monitoring of data quality and consistency in the Stomach cancer Adjuvant Multi-institutional Trial Group Trial","volume":"19","author":"Timmermans","year":"2016","journal-title":"Gastric Cancer"},{"issue":"4","key":"10.1016\/j.cct.2021.106368_bb0130","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1177\/009286151004400412","article-title":"PhRMA BioResearch Monitoring Committee perspective on acceptable approaches for clinical trial monitoring","volume":"44","author":"Usher","year":"2010","journal-title":"Drug Inf. J."},{"issue":"2","key":"10.1016\/j.cct.2021.106368_bb0135","article-title":"Fraud detection in supply chain using benford distribution","volume":"5","author":"Varma","year":"2012","journal-title":"Int. J. Res. Manag."},{"key":"10.1016\/j.cct.2021.106368_bb0140","doi-asserted-by":"crossref","first-page":"705","DOI":"10.1177\/1740774512447898","article-title":"A statistical approach to central monitoring of data quality in clinical trials","volume":"9","author":"Venet","year":"2012","journal-title":"Clin Trials."},{"key":"10.1016\/j.cct.2021.106368_bb0145","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1613\/jair.346","article-title":"Improved heterogeneous distance functions","volume":"6","author":"Wilson","year":"1997","journal-title":"J. Artif. Intell. Res."}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442100104X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S155171442100104X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T08:53:03Z","timestamp":1761555183000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S155171442100104X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5]]},"references-count":29,"alternative-id":["S155171442100104X"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2021.106368","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2021,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Risk-based centralized data monitoring of clinical trials at the time of COVID-19 pandemic","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2021.106368","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2021 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"106368"}}