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Trials Management

The Clinical Trials Managers provide support and assistance throughout the research process in terms of:

  • Advising Chief Investigators during protocol development with respect to ensuring UK legislation is adhered to.

  • Advising on applications for Clinical Trial Authorisation from the Medicines & Healthcare Regulatory Authority (MHRA) and on applying for approval from Research Ethics Committees.

  • Providing expert advice on regulatory & governance issues to senior managers, all Trust researchers and the members of the Trust’s Research, Development and Innovation Department.

  • Liaising with Pharmacy, Radiology, Laboratories, Medical Engineering and other support departments as appropriate.

  • Advising CIs, PIs and research team members on setting up Trial Master Files / Investigator Site Files for trials sponsored by the Trust.

  • Aiding investigators for site initiation visits.

  • Reviewing protocol amendments and ensuring that they are approved by the Trust, MHRA and Research Ethics Committee.

  • Assisting investigators in making applications to research grant awarding bodies.

  • Study Monitoring: Review of study documentation during the lifecycle of the study for:

  1. Ensuring that the project is conducted in accordance with the protocol, GCP and all relevant regulatory requirements

  2. Source data verification

  3. Ensuring accurate data transcription

  4. Review of consent forms

  • Working with study teams to combat any problems encountered during the study, such as recruitment issues, study logistics.

  • Aiding investigators with readiness for external audits and inspections by sponsors or regulatory bodies