Purpose of monitoring | |
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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. |