Table 4 Showing the link of the 5 principles of monitoring with the sources

Keeping participants safe and respecting their rights

Protecting the rights, safety, and welfare of subjects under the investigator’s care

FDA

The risk associated with the IMP should also determine the trial procedures for monitoring the safety of participants.

MHRA

Inspectors should verify procedures for reviewing and communicating findings that could adversely affect the safety of subjects.

EMA

[…] safety must be monitored in all trials and therefore the need for formal procedures to cover early stopping for safety reasons should always be considered.

ICH E9 3.4

[…] adequate oversight and monitoring during the trial will help ensure that trial subject safety is maintained throughout the trial.

NIHR

Having data we can trust

Careful attention to quality during trial planning, investigator training, trial monitoring and audit will help consistently achieve trial quality required.

ICH

Ensuring that data quality is sufficient to answer study question.

CTTI

Monitoring strategies, tailored to risks, should permit timely oversight and be focused on critical processes and critical data.

TransCelerate

Appropriate planning before the trial and adequate oversight and monitoring during the trial will help ensure that trial subject safety is maintained throughout the trial and that there is accurate reporting of results at its conclusion.

NIHR

Ensure … data quality across sites.

FDA

Making sure the trial was run as it was meant to be

[…] preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and processes necessary for human subject protection and trial integrity.

FDA

[…] perform checks that include: verification that trial documents exist, assessment of the site’s understanding of, and compliance with the protocol and trial procedures […]

NIHR

Essential documents are those ‘documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced’ and they serve to demonstrate compliance with the principles of GCP and regulatory requirements.

UKTMN

Investigators are appropriately selected, trained and supported to complete the proposed clinical trial (MHRA).

MHRA

Improving the way the trial is run

Monitoring during the trial will help ensure that trial subject safety is maintained throughout the trial and that there is accurate reporting of results at its conclusion.

NIHR

Monitoring strategies, tailored to risks, should permit timely oversight and be focused on Critical Processes and Critical Data. Notably, Investigators are responsible for their site’s data quality and are expected to partner with the Sponsor to address, resolve, and prevent issues.

TransCelerate

Chief investigators are responsible for the overall conduct of a research project including adhering to the agreed procedures and arrangements for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct, the participants’ safety and well-being and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments.

HRA

Moreover, a risk-based approach is dynamic, more readily facilitating continual improvement in trial conduct and oversight. For example, monitoring findings should be evaluated to determine whether additional actions (e.g. training of clinical investigator and site staff, clarification of protocol requirements) are necessary to ensure human subject protection and data quality across sites.

FDA

Maximizing efficiency for minimal resource use

CTTI

Preventing problems before they happen

Sponsors should prospectively identify critical data and processes, then perform a risk assessment to identify and understand the risks that could affect the collection of critical data or the performance of critical processes, and then develop a monitoring plan that focuses on the important and likely risks to critical data and processes.

FDA

A Trial Monitoring Plan will be developed and agreed by the Trial Management Group (TMG), TSC and CI based on the trial risk assessment which may include on site monitoring. This will be dependent on a documented risk assessment of the trial.

HRA

The sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes.

ICH

Once developed, the risk assessment and associated management/monitoring plans would form the basis of a common understanding by all stakeholders on the risks for that trial and facilitate a risk-proportionate approach to the trial activities.

MHRA

Risk-based monitoring: An adaptive approach [to clinical trial monitoring] that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact subject safety and data quality.

TransCelerate