Monitoring in practice - How are UK academic clinical trials monitored? A survey.

ABSTRACT:

Background

Despite the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) encouraging the use of risk-based monitoring for trials in 2013, there remains a lack of evidence-based guidelines on how to monitor. We surveyed the academic United Kingdom Clinical Research Collaboration (UKCRC) registered clinical trials units (CTUs) to find out their policy on monitoring of phase III randomised clinical trials of an investigational medicinal product (CTIMPs).

Methods

An online survey of monitoring policy with sections on the CTU, central monitoring and on-site monitoring was sent to all 50 UKCRC registered CTUs in November 2018. Descriptive data analysis and tabulations are reported using the total number answering each question.

Results

A total of 43/

SUBMITTER: Love SB 

PROVIDER: S-EPMC6953230 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature