A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process

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.