Principle | Examples |
---|---|
Keeping participants safe and respecting their rights | Ensure valid consent by checking the consent forms are completed correctly Ensure data available by checking that the expected data have been entered onto the database Look regularly at the amassed safety data and protocol compliance. Present to regulatory authorities, CI, DMC, TMG, REC and safety review committee and act upon their direction/advice. This may result in a change to the protocol or trial conduct. |
Having data we can trust | Develop a risk-based monitoring plan that identifies critical data and processes and focusses on ensuring their accuracy and integrity. Perform on-site and/or remote monitoring and/or central monitoring, where required. Build quality into the scientific and operational design and conduct of clinical trials including an audit programme to evaluate processes relating to data quality and perform root cause analysis and establish corrective and preventative actions where significant deficiencies are detected. |
Making sure the trial was run as it was meant to | Ensure site staff are appropriately trained and qualified to deliver their role on the trial and to follow trial specific procedures and processes (e.g. monitoring delegation and training logs, checking CVs). Collect and check protocol deviations/non-conformances and ensure systems are in place to mitigate risks of these happening again such as retraining and providing working practice documents. Ensure a monitoring plan is in place that allows timely evaluation of significant issues identified. |
Improving the way the trial is run | Ensure the trial adheres to GCP, protocol and ethical/regulatory guidelines. Ensure quality measure are reached by providing adequate staffing and resources. Continuously monitor and respond to issues in a timely manner with corrective actions when required/appropriate |
Preventing problems before they happen | Base the monitoring plan and activities on a risk assessment Undertake a risk assessment to assess the potential risks and puts things in place to prevent and monitor these risks. |