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ToolsLove, Sharon B., Yorke-Edwards, Victoria, Ward, Elizabeth, Haydock, Rebecca, Keen, Katie, Biggs, Katie, Gopalakrishnan, Gosala, Marsh, Lucy, O’Sullivan, Lydia, Fox, Lisa, Payerne, Estelle, Hood, Kerenza and Meakin, Garry (2022) What is the purpose of clinical trial monitoring? Trials, 23 (1). ISSN 1745-6215
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Abstract
Background: The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitoring tools on a strong easily communicated foundation, we identified the need to define monitoring in accessible language. Methods: In a three-step process, the material from sources that describe clinical trial monitoring were synthesised into principles of monitoring. A poll regarding their applicability was run at a UK national academic clinical trials monitoring meeting. Results: The process derived 5 key principles of monitoring: keeping participants safe and respecting their rights, having data we can trust, making sure the trial is being run as it was meant to be, improving the way the trial is run and preventing problems before they happen. Conclusion: From the many sources mentioning monitoring of clinical trials, the purpose of monitoring can be summarised simply as 5 principles. These principles, given in accessible language, should form a firm basis for discussion of monitoring of clinical trials.
| Item Type: | Article |
|---|---|
| Additional Information: | Funding Information: SBL and VYE were funded by MRC grant MC_UU_00004/08. LOS is funded by the Health Research Board-Trials Methodology Research Network grant (HRB-TMRN-2017-1). |
| Uncontrolled Keywords: | clinical trial monitoring,clinical trials methodology,trial conduct,medicine (miscellaneous),pharmacology (medical) ,/dk/atira/pure/subjectarea/asjc/2700/2701 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023) |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 20 Oct 2022 10:30 |
| Last Modified: | 26 Oct 2022 09:30 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/89237 |
| DOI: | 10.1186/s13063-022-06763-2 |
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