A new Trial Monitoring Plan (TMP) template for clinical trials: Output from a Delphi process

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.