Step by Step Guide

The CRF will guide you through the following steps...


The study team contacts the CRF to request CRF support, providing the study protocol or a copy of the grant proposal. This can be done by emailing rachel.whelpton@sth.nhs.uk

                          

A date is arranged for the study team to meet with the senior clinical team leader for a feasibility meeting to discuss the project requirements including resources and support service involvement. The meeting should take around 45 mins approx. A Guidance Document to prepare for the meeting is available.

                                                 

Once the feasibility meeting has taken place, the senior clinical team leader will put together an intensity which will generate costings for the study. After that time, the CRF can review the support required and look to provisioning the relevant resources.

                                                                           

After the meeting the study team will be sent a brief application form this is an easy and quick resource tool that should be completed and returned to the CRF. Depending on the phase and nature of the study the project will be approved for acceptance into the CRF portfolio by the senior Management team.

If the study is Experimental Medicine or Phase I or II the study will be reviewed by our SAB/Experimental Medicine Board.

                                                                                                      

Once the study is approved for acceptance into the CRF the study team will be sent a PI & CRF Responsibilities form. This form is the service level agreement confirming what the PI and the CRF have agreed too. The form contains the recruitment target number that has been agreed to at feasibility. The form also contains information regarding publications and we ask that when publishing papers, articles or reports, authors must acknowledge the support provided through the use of the NIHR Clinical Research Facilities.

The PI & CRF Responsibilities form needs to be signed and returned to the CRF either by hardcopy or with an electronic signature

                                                                                                                                   

Once we are in receipt of the PI & CRF Responsibilities Form the CRF Research Nurse Lead who has been assigned to your study will make contact with you, the Sponsor, and the Clinical Research Office to begin study set up activities to allow R&D approval before the study begins.

 

 

For more information about specific study set up activity or any specific project requirements, please ask your assigned CRF Lead Nurse who will be happy to help guide you.

 


Facilities
SOPs

The Application Process