NBT sponsored research study

The process that you need to follow when setting up an NBT sponsored study.

 

Apply for confirmation that NBT can sponsor the study

All research needs a sponsor who takes on the legal responsibility for the study.

Read SOP RI/QMS/SOP/007 and complete the accompanying sponsorship request form.

If you have a draft protocol/consent form/information sheet, please provide these at the point you submit the sponsorship request form. Please refer to the NBT HRA checklist (available on the NBT website) when preparing these documents (see Task 3, below).

Be prepared that you may to need to amend your documentation as part of the sponsorship review process.

Sponsorship assessment

A risk assessment needs to take place prior to R&I agreeing that will NBT sponsor any research.

Read SOP RI/QMS/SOP/007 for detail regarding the risk assessment process that will take place.

Develop your protocol and other supporting documentation

These are core documents that will need to be submitted in support of your application to regulatory bodies including REC, HRA and MHRA. These documents need to meet certain criteria prior to submission, as outlined in the NBT HRA checklist.

Work through the NBT HRA checklist, ensuring that you address each item in the checklist. Tick off each item as you complete it, and return the completed checklist and accompanying documentation to R&I. Sponsorship cannot be confirmed (i.e. no IRAS signatures can be issued by R&I) until this checklist is completed and returned with the final study documentation.

Complete the Statement of Activities and Schedule of Events

All studies require these documents to be submitted to the HRA (one of each, per site ‘type’ including Participant Identification Centres - PICs) unless the study is a single-site study that involves NBT only (in which case, no statement of activities or schedule of events is required).

Templates and guidelines are available via the HRA website. It is important that you complete these documents carefully and that the schedule of events for each site ‘type’ accurately reflects the full activity that will take place at that site.

Guidance on the attribution of costs required for completion of the schedule of events is available via the government services website.

Obtain draft contract from R&I

Some studies (not all) may require a contract between NBT as sponsor, and each participating site. R&I will confirm when this is required. If a contract is required, this must be submitted to HRA as part of the full application pack.

Check the requirement for a contract with R&I by emailing researchsponsor@nbt.nhs.uk. R&I will provide the contract, if one is required.

Apply to have the study included on the NIHR CRN portfolio

Studies that meet certain eligibility criteria are eligible to be included on the NIHR portfolio and receive NIHR CRN support.

Complete and submit a Portfolio Application Form (PAF) in IRAS

Invite sites to take part

This enables sites to start assessing whether they are likely to have the capacity and capability to support the study.

Provide sites with the protocol in a version to be submitted for regulatory review (i.e. the final version that you will be submitting to HRA).

This must be sent by email to the R&D department at each participating site including NBT, using the contact details available via the R&D Forum Website.

If you are applying to have the study included in the NIHR CRN portfolio, you must also copy each corresponding LCRN into this correspondence. Contact details for corresponding LCRNs are provided against each site via the R&D forum website.

Request sponsor sign-off of regulatory applications

The sponsor must sign all regulatory applications to indicate their intention to sponsor the research.

Authorisation requests should be submitted via IRAS. The authorisation requests should be sent to researchsponsor@nbt.nhs.uk

Sponsor sign-off of regulatory applications

The sponsor must sign all regulatory applications to indicate their intention to sponsor the research.

A delegated individual from R&I will sign the application via IRAS.

 

Submit your application to the relevant regulatory bodies for approval

All research must have the relevant regulatory approvals before it commences.

Guidance on how to apply for HRA (incorporating ethics, where REC approval is needed) is available via: http://www.hra.nhs.uk/research-community/applying-for-approvals/hra-approval/

Applications to the MHRA need to be submitted separately. Further details are available via: https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk
NBT will upload to the application to the CESP system on behalf of the researcher once the application is ready.

Obtain regulatory approvals

All research must have the relevant regulatory approvals before it commences.

The study cannot start without HRA approval, and HRA approval will not be issued until any other relevant regulatory approvals are in place, including REC and MHRA.

Commence arrangements for sites to deliver the research

You should send the following local document package simultaneously to the R&D department at each site (including NBT, if NBT are a site) and the LCRN (where applicable) once you have received the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter is issued). This should be sent using contact details available via the R&D Forum Website.

• Copy of IRAS Form as submitted for HRA Approval
• Protocol
• Any amendments
• Participant information and consent documents
• Statement of Activity relevant to that participating NHS organisation *
• Relevant template contract (if needed)
• Schedule of Events *
• Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
• Copy of HRA Initial Assessment letter (if one is issued) and (when issued) HRA Approval letter and final document versions – you must send sites one of these documents as a minimum.
If the final HRA approval letter is not available at the point you send the documentation through to sites, you must send it as soon as it becomes available

Negotiate/agree with sites the content of the statement of activities and/ clinical trial agreement*

All sites will need to agree with the NBT the content of the statement of activities and schedule of events (and contract, where relevant).

R&I should be consulted regarding any changes to the statement of activities, schedule of events, or contract.

Obtain confirmation from sites that they have the capacity and capability to deliver the research ***

All sites involved in the research, including NBT, must confirm in writing that they have made appropriate arrangements and therefore have the capability and capacity to deliver the research at their site, before any activity can commence at that site.

** There may be instances where this step is not required in which case you are advised to liaise with R&I for further guidance.

Sites will provide written confirmation. Please ensure this is forwarded to researchsponsor@nbt.nhs.uk.

The study must not start at the site until that site has issued conformation of capacity and capability to undertake the study. If the study is interventional, Tasks 15 & 16 must also be complete before the study can start at the site.

(Interventional Studies Only) Collate information for green light approval

Collate information for green light approval.

If the study is interventional, R&I will issue a green light approval for each recruiting site (except NBT). Activity at that site cannot commence until this green light approval has been issued.  At NBT, the study can start once confirmation is issued by R&I. 

R&I will confirm if your study requires this task to be completed.

You should provide the following documentation to R&I for each site:

• Signed and dated CV/GCP for PI at site
• The appropriate R&D contact details
• R&I confirmation of capability and capacity from the site
• Final agreed statement of activities and schedule of events agreed by the site.
• Final contract (where relevant) that has been signed by the site.

Interventional Studies Only : Issue green light approval

If the study is interventional, R&I will issue a green light approval for each recruiting site (except NBT). Activity at that site cannot commence until this green light approval has been issued.  R&I will confirm if your study requires this task to be completed.

R&I will provide written green light approval for the site.

The study must not start at a site until green light approval has been issued for that site.