M

• MHRA (Medicines and Healthcare products Regulatory Agency)

  The MHRA is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

  They have statutory powers both in the approval of drug / devices for licence and in approving Clinical Trials of Investigational Medicinal Products, and clinical investigations involving devices.

   

• Monitoring

  The process of monitoring a study should ensure that the rights and wellbeing of any participants are protected, the reported data are accurate and complete, and that the conduct of the study is in compliance with the approved protocol/amendments and with applicable regulatory/governance requirements.

  Monitoring should be built into the conduct of the study as a means to minimise risk, and should be ongoing and performed by members of the research team and people independent to it.