Trial Planning Phase

Trial Management & Monitoring follows the Protocol Development station and precedes the Trial Documentation station. Trial Management & Monitoring is a legal requirement which is relevant to all trials. This station is part of the ‘trial planning phase’ group of stations.

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.

The sponsor is responsible for ensuring that robust trial management systems are put in place. The monitoring of a trial is one of the key activities undertaken as part of the trial’s management. The MHRA accepts a risk-adapted approach to trial management and the advice specific to trial monitoring can be found in Appendix 2 of The Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products (pdf).

Risk-adapted trial management addresses the question:

What are the critical processes and critical data for this trial and how best can any risks and/or vulnerabilities identified in these areas be mitigated?

This question should be considered early in the protocol design stage so that processes to proactively manage those aspects of the trial that are critical to quality can be put in place. The US Clinical Trials Transformation Initiative (CTTI) have produced a Toolkit including Quality by Design principles that provides a useful framework for this process.

Where trial management activities are contracted out to third parties, the sponsor must implement procedures to ensure appropriate oversight of all delegated functions.  This can be achieved by:

  •  Assessing that individuals or organisations delegated trial management functions are appropriately qualified and competent to perform those functions.
  • Ensuring all parties are aware of their roles and responsibilities (for example by clearly defining them in contracts and agreements).
  • Maintaining lines of communication to ensure the obligations of all parties are being met (for example by receiving progress reports). 

Documentation should be in place to describe all key processes. This ensures that those performing tasks have a clear plan of what, when and how  trial activities are undertaken and also enables auditors/inspectors to historically reconstruct all trial management activities.

The following provide further information and guidance on trial management:

Further reading: