To help simplify the steps involved in setting up a clinical trial, we have condensed the various processes into three key stages (the red boxes).  We have then broken these down into three further sub-steps that should be completed before moving on to the next major stage.  The route map has been designed to complement the NIHR Clinical Trials Toolkit. Indeed much of the background information you will find in each stage (red boxes) and sub step (blue boxes) has been reproduced directly from the toolkit with the kind permission of NIHR.  In addition to this key information, we have added sections that describe where this help and support is available from within Greater Manchester’s research support infrastructure.

Over the next few months we will create an additional route map that will describe the steps required to deliver a clinical trial on a day to day basis.

Regenerative Medicine: Pre-Application Tools

If you are working in the field of regenerative medicine, and you are considering translation to a clinical trial, it is essential you address several points prior to applying for trial funding. If the correct regulatory questions are not addressed prior making an application, significant delays which may affect the success of your application, will be encountered; this is particularly pertinent for the translation of cell/gene therapy and novel biomaterials.

To assist in the pre-application planning for the translation of basic or pre-clinical research to clinical trial, the Manchester Regenerative Medicine (MaRM) Network has created a set of Pre-Application Tools to help assure the application process proceeds as expediently as possible.

We hope you will find the route map useful in helping set up your clinical trial.

Click on the graphic to be taken to further information about the clinical trials set up process.

Clinical Trials Flowchart

 

Trial Planning Funding Protocol Development Sponsorship and Risk Assessment Approvals Checklist MHRA Ethics Local Research and Development Key Considerations Contracting Third Party Services Training Supplies and Equipment Trial Management Arrangements Trial Documents Pharmacovigilance Data Management Activities Trial Commences