Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study.

ABSTRACT:

Background/aims

In multi-site clinical trials, where trial data and conduct are scrutinised centrally with pre-specified triggers for visits to sites, targeted monitoring may be an efficient way to prioritise on-site monitoring. This approach is widely used in academic trials, but has never been formally evaluated.

Methods

TEMPER assessed the ability of targeted monitoring, as used in three ongoing phase III randomised multi-site oncology trials, to distinguish sites at which higher and lower rates of protocol and/or Good Clinical Practice violations would be found during site visits. Using a prospective, matched-pair design, sites that had been prioritised for visits after having activated 'triggers' were matched with a control ('untriggered') site, which would not usually

SUBMITTER: Stenning SP 

PROVIDER: S-EPMC6236642 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature