Sponsorship Request Form

Sponsorship Request Form

/
Form
Sponsorship Request Form
This template accompanies RI/QMS/SOP/007- Applying for NBT Sponsorship
REFERENCE: / RI/QMS/SOP/007a
VERSION NUMBER: / 1.2
EFFECTIVE DATE: / 18-07-17
REVIEW DATE: / 18-07-19
AUTHOR: / Clinical Trials Manager
REVIEWED BY: / R&I Senior Team
APPROVED BY: / Deputy Director of Research
CONTROLLER: / Contracts & Quality Management Officer
Document Version History
VERSION NUMBER / EFFECTIVE DATE / REASON FOR CHANGE
1.0 / 08-02-16 / Clarification regarding healthy volunteer studies
1.1 / 15-09-16 / Minor updates made to clarify that there is a presumption for academic organisations to sponsor MSc studies. Addition of ‘Rationale for sponsorship decision’ box.
Current versions of all Research & Innovation SOPs and accompanying documents are available online. If you are reading this document in printed form, please check that the version number and date match the most recent version on the Research & Innovation website:

Sponsorship Request Form

Please submit this form to: /
Please include the following in the email subject: / Sponsorship Request
If already available, please provide the following: / Draft protocol
Draft participant information sheet
Draft consent form
Please refer to this SOP when completing this form: / Applying for NBT Sponsorship (RI/QMS/SOP/007)

SECTION 1:

Project Title:
Chief Investigator name:
Chief Investigator’s substantive employer:

SECTION 2:

Please note that if your project meets any of the criteria outlined below, it is unlikely that NBT will be able to sponsor the study.

If you tick yes to any of the criteria, it is therefore recommended that you get in touch with R&I to discuss further before proceeding with the rest of this form.

For MSc projects there is an expectation that the academic organisation would act as sponsor for the project as if forms part of the learning experience.

Criteria / Yes / No
This is a Phase 1 CTIMP study involving healthy volunteers
This is a randomised trial involving healthy volunteers
This study includes sites outside UK
This is commercial contract research
The Chief Investigator does not work for NBT and does not hold an honorary contract with NBT
This is an academic project undertaken as part of an academic qualification
This study would involve co-sponsorship with another organisation
This study is being undertaken as part of an MSc

SECTION 3:

Has funding been obtained? / Yes
No
If yes, please provide details:
If no, please provide details of how the project will be funded:
Will any part of this project contribute to an educational qualification? / Yes
No
If yes, please provide details:
Anticipated start date of recruitment
Anticipated end date of recruitment
Length of patient follow-up
How many patients do you intend to recruit in total to the project?
How many sites will you recruit from (including NBT)?
Is the study interventional? / Yes
No
If yes, please provide details of the intervention:
Does the study involve an Investigational Medicinal Product (IMP) and/or Device? / Yes
No
If yes, please provide details of the IMP/Device:
If yes, please indicate who will provide the IMP/Device:
If yes, please provide details of what phase trial this is (IMP) or CE marking status (Device):
Will any third parties be involved (e.g. a trials units, or other service provider) at any stage of the research (e.g. management, supplies, etc): / Yes
No
If yes, please provide details:
Have scientific/peer reviews of the project been undertaken? / Yes
No
If yes, please provide copies when submitting this form
Will any computer systems be used for managing study data (e.g. databases, spreadsheets, bespoke software): / Yes
No
If yes, please provide details:
Does the chief investigator or any other member of the research team have any conflict of interest?
NOTE:
You are making an application for NBT to act as Sponsor for a study.
For any study that NBT subsequently agrees to sponsor, the following will apply:
  • The Chief Investigator will have overall responsibility for ensuring that the study is conducted in accordance with all applicable regulations and in accordance with NBT SOPs available on the NBT website at:
  • The Chief Investigator must agree to theNBT Terms & Conditions of Sponsorship, and to accept their delegated responsibilities, as outlined in the SOP on Applying for NBT Sponsorship (RI/QMS/SOP/007).
  • The Chief Investigator will be accountable to the Sponsor.
  • Sponsorship may be withdrawn where the Chief Investigator fails to comply with the NBT Terms & Conditions of Sponsorship.

FOR R&I USE ONLY
Suitable for consideration?
Likely to fall under simple or complex definition during risk assessment?
Recommendations?
Rationale for sponsorship decision
Reviewed by:
Date reviewed:

Version 1.2/18-07-17/Page 1 of 4

RI/QMS/SOP/007a