Monitoring

This chapter discusses the role and responsibilities of monitors/CRAs seeking to improve awareness of their role in a global industry becoming more and more technologically focused. How the role is changing through the introduction of risk based monitoring. Often the only liaison between the Sponsor and each study site, CRAs are crucial to the successful completion of a clinical trial and need to be armed with appropriate knowledge and training to conduct their visits. Successful monitoring requires experience, people skills, management ability and knowledge – of the protocol, CRFs, study drug/device, therapeutic area, regulations and SOPs. In this chapter this spectrum of roles and responsibilities is presented in a concise and understandable format. Questions such as: What type of person makes a good monitor? EDC and/or paper? How – and how often – to monitor? are addressed. There are helpful tips and strategies on a variety of topics, notably preparing a monitoring plan; how to identify and assess potential investigators; preparing for a Study Initiation Visit; eCRFs and remote monitoring; thorough Source Data Verification; how to report monitoring visits plus example checklists associated with site visits and review of the Investigator Site File. The guidance provided in this chapter should help CRAs perform their essential role in encouraging good, high quality research - and provide an insight into the CRA role to those whose work is being monitored.