Conducting a Phase I/GM trial
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 CMFT premises (which includes the CRF) 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. This needs to be early in the set-up process so that the Trust (and CRF) can assess that we have sufficient capacity and capability to conduct the trial.
EPSCs guidance, meeting dates and application deadlines 2019 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 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 selected members of the EPSC – please be aware that applications containing insufficient information will be returned to the PI, which may delay the start of your trial.
- 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.
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 new process. Therefore, if you require any further information, including advice on the appropriate timescale for submission in line with the HRA process, please contact your Divisional Research Manager.