CNTW can sponsor studies from low-risk, small-scale observational projects to complex Clinical Trials of an Investigational Medicinal Product (CTIMPs).
Initial Submission to R&D:
The below documentation is required to form a valid sponsorship submission for all studies:
- Evidence that the Chief Investigator is substantively employed by CNTW, or that they hold an honorary research contract with us.
- PDF version of the full trial dataset from the Integrated Research Application System (IRAS)
- Copy of the current protocol, or project proposal, with version number and date
- Copy of the proposed participant information sheet and informed consent form with version number and date
- Organisation Information Document (OID) or Model Agreement for Non-Commercial Research (mNCA) (where appropriate, when more than one site)
- Schedule of Events Cost Attribution Template (SoECAT) or Schedule of Events (SoE)
- Copy of the independent scientific peer review for non-funded applications
- Details of the any applicable funding for the study
- Confirmation that all vendor agreements/contracts are signed (if applicable)
- Updated trial costings that reflect the protocol version being submitted (where applicable)
- Completed Risk Assessment Form
- Chief Investigator Research CV and GCP Certificate (2 pages signed and dated and noting relevant experience, training or GCP Training Date)
Where the study is a CTIMP or interventional study, the below should also be included within a sponsorship submission:
- Evidence that any NHS Treatment Costs have been approved by CNTW (where applicable)
- Excess Treatment Cost per participant (where applicable)
- Local collaborators Research CV and GCP Certificate (two pages signed and dated and noting relevant experience, training or GCP Training Date)
Valid sponsorship submissions should be made to: [email protected]
Once we have received your submission, we will review the request and provide feedback and comments within three weeks.