Purpose of monitoring
Key principles in lay terms
Key principles in more technical language
Keeping participants safe and respecting their rights
To ensure, enhance and protect participants’ safety, wellbeing and rights.
Having data we can trust
Having the systems and processes (such as source data verification) to ensure that each data item is as reliable as is needed to be sure of the results of the trial
Making sure the trial is run as it was meant to be
Maintain trial integrity by ensuring the trial is conducted in compliance with the currently approved protocol/documentation, with GCP and with the applicable regulatory requirements
Improving the way the trial is run
Improving quality, conduct and efficiency in clinical trials.
Preventing problems before they happen
Contingency and mitigation planning for risks to both participant safety and trial processes.