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Table 2 Purpose of monitoring key principles synthesised from major worldwide organisations

From: What is the purpose of clinical trial monitoring?

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.