{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T06:34:25Z","timestamp":1772778865074,"version":"3.50.1"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T00:00:00Z","timestamp":1618358400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T00:00:00Z","timestamp":1618358400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012891","name":"Medical Research Charities Group","doi-asserted-by":"publisher","award":["UU 12023\/24"],"award-info":[{"award-number":["UU 12023\/24"]}],"id":[{"id":"10.13039\/100012891","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.<\/jats:p>\n                  <jats:p>Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in United Kingdom Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTUs) within the UK.<\/jats:p>\n                  <jats:p>The UKCRC Monitoring Task and Finish Group, comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or\/and remote monitoring.<\/jats:p>\n                  <jats:p>Monitoring, required to protect the safety of the patients and the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMFs) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.<\/jats:p>\n                  <jats:p>The arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.<\/jats:p>","DOI":"10.1186\/s13063-021-05225-5","type":"journal-article","created":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T15:49:50Z","timestamp":1618415390000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6695-5390","authenticated-orcid":false,"given":"Sharon B.","family":"Love","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Armstrong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carrie","family":"Bayliss","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melanie","family":"Boulter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Fox","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne","family":"Grumett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Rafferty","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Temesi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krista","family":"Wills","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Corkhill","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,4,14]]},"reference":[{"key":"5225_CR1","unstructured":"International Conference on Harmonisation of technical requirements for pharmaceuticals for human use (ICH). Guideline for good clinical practice E6(R2) 2018 [Available from: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf ] Accessed 14_Jul_2020."},{"key":"5225_CR2","unstructured":"Medicines and Healthcare products Regulatory Agency. Good clinical practice guide: The Stationery Office; 2012."},{"key":"5225_CR3","doi-asserted-by":"publisher","unstructured":"Beever D, Swaby L. An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units. Trials. 2019;20;556. https:\/\/doi.org\/10.1186\/s13063-019-3619-6.","DOI":"10.1186\/s13063-019-3619-6"},{"key":"5225_CR4","unstructured":"Federal Drugs Agency. Guidance for industry. Oversight of clinical investigations\u2014a risk-based approach to monitoring [Available from: https:\/\/www.fda.gov\/downloads\/Drugs\/Guidances\/UCM269919.pdf ] Accessed 7_May_2020."},{"key":"5225_CR5","unstructured":"European Medicines Agency. Reflection paper on risk based quality management in clinical trials 2020 [Available from: https:\/\/www.ema.europa.eu\/documents\/scientific-guideline\/reflection-paper-risk-based-quality-management-clinical-trials_en.pdf ] Accessed 7_May_2020."},{"key":"5225_CR6","unstructured":"Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products 2011 [Available from: https:\/\/webarchive.nationalarchives.gov.uk\/20150111011944\/http:\/\/www.mhra.gov.uk\/home\/groups\/l-ctu\/documents\/websiteresources\/con111784.pdf] Accessed 6_Jul_2020."},{"key":"5225_CR7","unstructured":"RECOVERY-RS [Available from: https:\/\/warwick.ac.uk\/fac\/sci\/med\/research\/ctu\/trials\/recovery-rs\/] Accessed 25_Jun_2020."},{"key":"5225_CR8","unstructured":"Informing participants and seeking consent 2019 [Available from: https:\/\/www.hra.nhs.uk\/planning-and-improving-research\/best-practice\/informing-participants-and-seeking-consent\/] Accessed 10_Jun_2020."},{"issue":"1","key":"5225_CR9","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1177\/2374373519827029","volume":"7","author":"A Meehan","year":"2020","unstructured":"Meehan A, Bundorf MK, Klimke R, Stults CD, Chan AS, Pun T, Tai-Seale M. Online consent enables a randomized, controlled trial testing a patient-centered online decision-aid for Medicare beneficiaries to meet recruitment goal in short time frame. J Patient Exp. 2020;7(1):12\u20135. https:\/\/doi.org\/10.1177\/2374373519827029.","journal-title":"J Patient Exp"},{"key":"5225_CR10","unstructured":"Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic 2020 [Available from: https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf] Accessed 10_Jun_2020."},{"key":"5225_CR11","unstructured":"The medicines for human use (clinical trials) and blood safety and quality amendment 2008 [Available from: http:\/\/www.legislation.gov.uk\/uksi\/2008\/941\/contents\/made] Accessed 25_Jun_2020."},{"key":"5225_CR12","unstructured":"The medicines for human use (clinical trials) (amendment no. 2) regulation 2006 2006 [Available from: http:\/\/www.legislation.gov.uk\/uksi\/2006\/2984\/contents\/made] Accessed 14_Jul_2020."},{"key":"5225_CR13","doi-asserted-by":"crossref","unstructured":"Managing clinical trials during coronavirus (COVID-19): remote monitoring for trials 2020 [Available from: https:\/\/www.gov.uk\/guidance\/managing-clinical-trials-during-coronavirus-covid-19#remote-monitoring-for-trials] Accessed 6_Jul_2020.","DOI":"10.1016\/j.conctc.2020.100637"},{"issue":"12","key":"5225_CR14","doi-asserted-by":"publisher","first-page":"2784","DOI":"10.1111\/bcp.14108","volume":"85","author":"C Fougerou-Leurent","year":"2019","unstructured":"Fougerou-Leurent C, Laviolle B, Tual C, Visseiche V, Veislinger A, Danjou H, Martin A, Turmel V, Renault A, Bellissant E. Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials: a prospective comparative study. Brit J Clin Pharmaco. 2019;85(12):2784\u201392. https:\/\/doi.org\/10.1111\/bcp.14108.","journal-title":"Brit J Clin Pharmaco"},{"issue":"1","key":"5225_CR15","doi-asserted-by":"publisher","first-page":"535","DOI":"10.1186\/s13063-020-04388-x","volume":"21","author":"E Crowley","year":"2020","unstructured":"Crowley E, Treweek S, Banister K, Breeman S, Constable L, Cotton S, Duncan A, el Feky A, Gardner H, Goodman K, Lanz D, McDonald A, Ogburn E, Starr K, Stevens N, Valente M, Fernie G. Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project. Trials. 2020;21(1):535. https:\/\/doi.org\/10.1186\/s13063-020-04388-x.","journal-title":"Trials."},{"key":"5225_CR16","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1016\/j.jclinepi.2018.04.011","volume":"100","author":"LA Jefferson","year":"2018","unstructured":"Jefferson LA, Fairhurst CM, Brealey SD, Coleman I, Cook E, Hewitt CE, et al. Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial: an embedded randomized trial. 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