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Trial Management & Monitoring
Trial Management & Monitoring

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 Link open in a new window. The MHRA GCP Forum: Frequently Asked Questions on the Risk Adaptive ApproachLink open in a new window provides further advice.

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:

a) Assessing that individuals or organisations delegated trial management functions are appropriately qualified and competent to perform those functions.

b) Ensuring all parties are aware of their roles and responsibilities (for example by clearly defining them in contracts and agreements).

c) 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:

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Key to Symbols

  • Demonstrates processes that can be done in parallel
  • Demonstrates that not all processes will apply to all trials
Standard Process Legal Requirement Good Practice
Specific for trials within Directive's scope
Relevant to all trials