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 . The MHRA GCP Forum: Frequently Asked Questions on the Risk Adaptive Approach 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:
- The Summary of Trial Management Systems Workstream Document (pdf, 125.32 KB) gives an overview of the activities associated with trial management as well as the requirement for oversight and documentation of those activities.
- The Monitoring Procedures Workstream Document (pdf, 113.07 KB) gives further information on the types of monitoring a sponsor may implement (for example on-site monitoring or central statistical monitoring) and the documentation of all aspects of the monitoring process. Further examples of risk adaptation are also provided in the following Joint Project Workstream Documents:
- The MHRA GCP Guide outlines the expectations for trial management and monitoring and provides a detailed description of all key processes and many examples of risk adaptation.
- The Trial Managers Network (TMN) is a source of practical support and guidance on the trial management process and has published comprehensive guidance: A Guide to Efficient Trial Management
- The MRC HTMR Network host a series of webinars on trial conduct including Monitoring trials efficiently: The role of central statistical monitoring.
- ICH (GCP (Section 5): Sponsor Requirements
- The GCP Inspectors Working Group have published a number of documents relating to trial processes:
- Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (PDF, 135 KB)
- Draft Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials (PDF, 127 KB)
- Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (PDF, 127 KB)
- In England, procedures developed by NHS sponsors conducting trials should meet the requirements of the Research Support Services (RSS) framework documents: See RSS Framework-Annex5-S09-Ensure study oversight (May 2011).
- A Data Sharing Guidance document has been produced as part of an MRC Hubs for Trials Methodology Research funded research project. This summaries good clinical practice principles to follow when sharing individual participant data from publicly funded clinical trials.
We would welcome your feedback and suggestions on how we can improve the toolkit. Please help to keep the toolkit up-to-date by reporting any out-of-date content or broken links.Go to form
- Trial Planning & Design
- Within the scope of the Clinical Trial Regulations?
- Risk Assessment
- Protocol Development
- GCP & Serious Breach Reporting
- Trial Management & Monitoring
- Trial Documentation
- Trial Supplies
- R&D Consultation
- Funding Proposal
- Peer Review
- Funding Secured
- Trial Master File
- Unique Trial Number
- EudraCT Number
- Confirm Sponsor
- Feasibility & Investigator Selection
- Contracts & Agreements
- Final Protocol
- CI Checklist Before Seeking Approval
- CTA Submission
- Ethics Submission
- R&D Submission
- Permissions & Approvals Obtained
- Final Trial Management Documentation
- Trial is Abandoned
- Trial Begins
- Informed Consent
- Safety Reporting
- Progress Reporting
- Ongoing Management & Monitoring
- MHRA Inspection
- Addition of New Sites & Investigators
- Substantial Amendments
- Urgent Safety Measures
- Temporary Halt or Early Termination
- Trial does not Recommence
- End of Trial Declaration
- Statistical Data Analysis
- Clinical Trial Summary Report
- Dissemination of Results
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|