How to Gain Trial Sponsorship from the University of Manchester
When you apply for sponsorship, you should come prepared with a peer-reviewed protocol. Further details on this are included in the “How To Set Up a Clinical Trial” page.
Please send your peer-reviewed protocol to firstname.lastname@example.org to commence the sponsorship process.
In addition, we will require the following when you initially apply for sponsorship:
Information about the Trial:
• The classification of your trial (link to “is my study a clinical trial?”)
• A peer-reviewed protocol
• Study-specific documents (assessments or measures such as questionnaires, screening tools etc.)
• An estimate of trial timelines
• Confirmation of engagement with a statistician and statistical review
• Confirmation of a data management plan
• FOR CTIMPS: an investigators brochure (IB) for unlicensed IMPs; a Summary of Medicinal Product Characteristics (SmPC) for marketed IMPs
• The name of the proposed lead pharmacist (if using) and evidence of in principle acceptance by the pharmacist and the pharmacist's employer
• An estimate of trial timelines
• A current Curriculum vitae for the CI (updated within last 2 years)
• An Organisational Information Document
• Evidence of the proposed research having undergone internal (and, where necessary, external) peer-review
• Faculty approval (this will be from the head of school, typically in the form of an email stating that they support the trial)
• Your estimate of the trial costs (we will factor in sponsorship costs)
• Confirmation that the lead NHS R&D site has agreed to host the trial, and confirmation of other host organisations
• List of vendors likely to be used in the trial and confirmation (at least in principle) of what activity they will be providing (e.g., CTU, IMP distributor, randomisation service, GMP facility, laboratories)
If Using a Clinical Trials Unit (CTU):
• A complete list of activities the CTU has agreed to provide for the trial (please point out any cost related activities the CTU has not agreed to carry out)
• Confirmation of the proposed level of trial management that the CTU will provide, and what the CTU expects the sponsor/CI to undertake
• FOR CTIMPS: Confirmation of IMP costs the CTU has provided for this trial (including any manufacturing, labelling, distribution and storage costs)
• Confirmation that the CTU agrees to the pharmacist, their roles and responsibilities
• Confirmation of the proposed level monitoring for this trial as agreed with the CTU
• Any issues the CTU has raised for this application that remain unresolved
We will also ask you to complete:
• An insurance form
• A checklist for third party agreements
• A risk categorisation form if your trial is a CTIMP
We require 10 working days from receiving the last document to review your documents for legal compliance and complete a risk assessment of your trial based on the information in your peer-reviewed protocol.
When we have reviewed these documents, we will request any changes we feel are needed.
Once the changes have been made, and the risk assessment shows that UoM can sponsor your trial, we will provide:
• An indemnity statement
• A letter of sponsorship in principle
These documents can be used as proof of insurance and sponsorship respectively when you make your funding and IRAS applications.
We will then commence the Greenlight Process. This process is what grants you permission from the university to begin your trial.
The Greenlight Process occurs in two parts. The first part can be completed while you make your IRAS application. We will send you a checklist of tasks to complete and ask that you send us any additional documents you have (such as patient information sheets, informed consent forms etc.). We will also liaise other teams in the department, such as the contracts team and insurance office.
The second part of the Greenlight Process starts when you have been given approval from the relevant regulatory bodies (MHRA, HRA, and an NHS REC – your trial may not require all of them). We will send a second checklist through for you to complete, and will require all the documentation you have for the trial in the format that has been approved by the MHRA/HRA/REC. We will also finalise our sponsorship statement, insurance, and all contracts and agreements.
Once the two-part Greenlight Process is completed, the university can give you permission to begin recruitment for your trial.