Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.

ABSTRACT:

Background/aims

It is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have recently encouraged more risk-based monitoring. Risk assessment should take place before a trial begins to define the overarching monitoring strategy. It can also be done on an ongoing basis, to target sites for monitoring activity. Various methods have been proposed for such prioritisation, often using terms like 'central statistical monitoring', 'triggered monitoring' or, as in the International Conference on Harmonization Good Clinical Practice guidance, 'targeted on-site monitoring'. We conducted a scoping review to identify such methods, to establish if any were supported by adequate evidence to allow wider implementat

SUBMITTER: Cragg WJ 

PROVIDER: S-EPMC8010889 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature