Supporting researchers, clinicians and organisations prepare for clinical trial monitoring for quality and safety, is the aim of a new podcast launched by Maridulu Budyari Gumal (SPHERE), NSW Regional Health Partners and Sydney Health Partners
Clinical trial monitoring is an ongoing quality process to make sure the trial is running in accordance with regulations and the trial protocol.
Episode 2 of the 'Clinical Trials in Focus' podcast Monitoring Clinical Trials for Quality and Safety explores monitoring for quality when the trial’s sponsor is a Local Health District, Medical Research Institute or University, and the trial is investigator-initiated rather than commercially sponsored.
The requirement for monitoring is set out in ICH Good Clinical Practice, which defines the purpose of clinical trial monitoring to verify:
(a) The rights and well-being of human subjects are protected.
(b) The reported trial data are accurate, complete, and verifiable from source documents.
(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).”
(ICH GCP 5.18.1)
In Australia, the National Statement on Ethical Conduct in Human Research notes that responsibility for ensuring research is reliably monitored lies with the institution under which the research is conducted. It notes that the mechanisms for monitoring can include:
(a) reports from researchers;
(b) reports from independent agencies (such as a data and safety monitoring board);
(c) review of adverse event reports;
(d) random inspections of research sites, data, or consent documentation; and
(e) interviews with research participants or other forms of feedback from them.
From 2023, the National Clinical Trials Governance Framework is being implemented in the public health system across Australia. One of its quality measures is the process to monitor the conduct of the trial in adherence to the approved protocol.
To help sites prepare to monitor for quality and safety, the three Research Translation Centres have also developed a Resource Pack.
These resources can be downloaded from https://www.sphereclinicaltrials.com.au/monitoring