Taheri, Shiva;
Yorke-Edwards, Victoria;
Sydes, Matthew R;
Isaacs, Talia;
Love, Sharon B;
(2024)
A new Trial Monitoring Plan (TMP) template for clinical
trials: Output from a Delphi process.
Research Square: Durham, NC, USA.
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Abstract
BACKGROUND: Monitoring is a crucial part of trial conduct and ensures that participants’ data is fairly represented, and future healthcare information is enhanced. This project aims to improve trial monitoring by creating a Trial Monitoring Plan (TMP) template with input from individuals experienced in monitoring clinical trials. METHODS: A review of monitoring plans received from UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Units (CTU)s created the basis for a preliminary TMP template and a Delphi survey. The TMP template was finalised after 2 rounds of a Delphi survey and a two-part consensus meeting including trialists with experience and expertise in monitoring clinical trials. RESULTS: 31 monitoring plans were received from UKCRC registered CTUs. The process resulted in a standardised TMP template with input from many individuals with interest, experience, or expertise in monitoring clinical trials. CONCLUSION: A TMP template was developed building on the currently used monitoring plans and with input from those experienced in clinical trial monitoring. Using a centrally developed good quality TMP template should contribute towards maintaining consistency in monitoring standards across all CTUs, resulting in higher research quality and improved quality assurance. Its use should provide reassurance to participants that their participation is carefully monitored to ensure that their data or any samples provided are treated with confidentiality, integrity, and respect and that their rights and well-being are protected.
| Type: | Working / discussion paper |
|---|---|
| Title: | A new Trial Monitoring Plan (TMP) template for clinical trials: Output from a Delphi process |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.21203/rs.3.rs-4257901/v1 |
| Publisher version: | https://doi.org/10.21203/rs.3.rs-4257901/v1 |
| Language: | English |
| Additional information: | © 2024 This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). |
| Keywords: | Trial monitoring plan, Clinical trial monitoring, Trial conduct, Delphi survey, Consensus |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10204511 |
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