Guidance
In order to run a Phase I or gene modification (GM) trial at MFT, as part of the MFT Assessment of Capacity and Capability process, your trial will be reviewed by the Early Phase Safety Committee (EPSC). Other high risk early phase trials may also be required to have EPSC review. EPSC meetings are held monthly. The committee has been created by the R&I Division in line with the MHRA’s Phase I Accreditation Scheme criteria. The aim of the committee is to give improved assurance that Phase I/GM trials being conducted on MFT premises (which includes NIHR Manchester Clinical Research Facility) meet the highest standards of safety and quality, bringing our facilities in line with best practice, reducing risk and enhancing the Trust’s reputation as a centre of excellence for early phase trials.
- Review process Send the following documents to R&D.applications@MFT.nhs.uk including “EPSC” in subject line of email. There are deadlines each month for applications, which can be found in the EPSCs guidance, meeting dates and application deadlines 2024 document below. Applications need to be received prior to the deadline to be considered for the next month’s meeting. Please note that there is a maximum of three applications reviewed at each meeting and this is usually on a first come first served basis, unless there is an urgent clinical need which will be assessed by the chair of the committee.
EPSCs guidance, meeting dates and application deadlines 2024 Documents to submit:
- Fully completed EPSC Risk Assessment Form or EPSC Risk Assessment Form for Gene Therapy Trials
- Protocol (can be a near finalised draft)
- Investigator’s Brochure
- Current, signed research CVs and GCP certificates for the Principal Investigator and any other local clinicians involved in the trial
- Assessment of submission The principal investigator’s (PI) submission will receive a preliminary review for quality of completion by the EPSC administrator. Please be aware that applications containing insufficient information will be returned to the PI and research team.
- EPSC meeting After a satisfactory preliminary review the PI will be required to attend the next EPSC meeting in order to have the opportunity to discuss the trial directly with the Committee and answer any questions, thereby reducing delays in assessment of capacity and capability. It is a requirement of the committee that the PI is present for the meeting. If the PI can not attend the meeting, the study will not be reviewed and will move to the next meeting that the PI is available to attend.
The PI will be notified of the outcome of the review in writing as soon as possible following the meeting. The R&I Division is keen to provide advice and support to assist you in following this process. Therefore, if you require any further information, including advice on the appropriate timescale for submission in line with the HRA process, please contact: R&D.Applications@mft.nhs.uk.
