Setting up your study
For internal researchers
If you are a researcher employed by the Trust, please refer to the Research and Innovation Intranet section, which has extensive advice and documents on how to set up a study. For Trust sponsored studies your Divisonal Research Manager (DRM) will review all documentation prior to requesting sponsor authorisation from designated Research Office staff.
For external researchers and sponsors
If you are new to research or wish to conduct research at the Trust from an external organisation such as a University, Pharmaceutical or Clinical Research Organisation, please read the following guidance carefully. For HRA approved studies:- all official correspondence from the sponsor to MFT such as confirmation of site selection, submission of full local information pack, HRA approval notification and amendments are to be submitted to the Trust Research Office at R&D.firstname.lastname@example.org
1. Principal Investigator
- Firstly identify the Principal Investigator at the Trust and discuss the study with them.
- The DRM can assist with identifying an appropriate researcher within a speciality for feasibilities.
2. Evaluation Meeting
- Invite the appropriate DRM (logistics) and the Research Office Research Support Officer (regulatory information) for the speciality to facilitate rapid set up within the Trust.
3. MFT Research Infrastructure
- Our research infrastructure runs throughout all eight hospitals, so a designated individual within the clinical area will be assigned. They will assist with the logistics of setting up your study within the Trust.
- Using a draft protocol (or final if ready) identify the support departments required and the tests, scans, facilities, resource needed to undertake your study- this includes whether you would like the study to take place at the NIHR Manchester Clinical Research Facility (incorporating Manchester Children’s CRF) located on site. [Your assigned co-ordinator will notify the departments so they can assess whether they can undertake the protocol requirements].
- Use NIHR template contracts to facilitate rapid set up.
- Costing of studies and subsequent negotiation can start as soon as a draft protocol is available, the NIHR costing template will be used for all commercial studies.
- Answer any specific queries from support departments.
- Get all documentation to a finalised format and assist in submitting a MFT Site Specific Information form*.
- If you are a non-MFT employee who wants to come on site to conduct their own research, see here for details of the Research Passport system which facilitates this nationally.
*If your study is gaining approval through the HRA approval system, the full local information pack (including the HRA Initial Assessment Complete letter) should be submitted to R&D.email@example.com. We no longer require an SSI, as long as we have the local team and location within CMFT. [Your assigned co-ordinator should provide these on registration of the study, however during the transition to HRA approval there will need to be flexibility due to dual systems being in place.]
5. Performance Management
- MFT performance manage all studies to try and achieve a first patient (or active study for non-patient studies) within 70 days of a valid submission to the Research Office.
- For our latest performance figures please see here.
- A study can not start until R&D approval is issued by the MFT Research Office (or until MFT Research Office has confirmed capacity and capability to deliver an HRA approval study).
- If you would like to arrange a Study Initiation Visit (SIV) prior to R&D approval, (or HRA approval) permission must be sought from the MFT Research Office.
- Visit our post-approval requirements for hosted studies page.