Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit.

ABSTRACT:

Background

Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners.

Methods

This paper describes the monitoring methods and procedures that are utilised by a non-commercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks.

Results

Monitoring activities and approaches should be selected to be proportionate to the risks identified within a

SUBMITTER: Tudur Smith C 

PROVIDER: S-EPMC4022377 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature