FAQ’s – Governance

• A PI is an individual responsible for the conduct of the research at a research site. There should be one PI for each research site.

• A CI is an individual who is responsible for the conduct of the whole project in the UK.

• All Research Studies running through CNTW will need a local PI, this is someone who is employed by CNTW and a specialist in that area. It can also be someone who is not employed by CNTW but holds a Clinical Contract with the Trust.

• All research projects running through CNTW will require a CI, this is someone who is responsible for the conduct of the entire project throughout the UK.

• We would advise using the HRA Decision Tool to identify if your study is classified as research. If your study is research please contact [email protected] and someone can advise appropriately.

• If your study is not categorised as research and falls under a Service Evaluation we would advise contacting [email protected] where they can advise appropriately.

• If your study is classed as clinical audit, please contact the clinical audit team at [email protected] where they can advise appropriately.

• The Health Research Authority is an executive non-departmental public body of the Department of Health in the United Kingdom. The HRA exists to provide a unified national system for the governance of health research.

• The HRA ensure all research is ethically reviewed and approved and oversees a range of committee and services. They promote transparency in research and provide independent recommendations on the processing of identifiable patient information where it is not always practical to obtain consent, for research and non-research projects.

• The HRA is governed by a Board composed of five non-executive directors, including the chair, and three executive directors.

• IRAS is a single system for applying for the permissions and approvals for Health and Social Care and Community Care Research in the UK.

• The IRAS System enables you to enter project specific information once instead of a duplication of information in multiple forms.

• You are able to use filters to ensure all data collected and collated is appropriate to your research project and ensures all of the correct permissions and approvals required are obtained.

• All Research Studies running through CNTW will always require a study Sponsor, unless your project falls under the student route then you will not be required to have a sponsor for the project.

• A sponsor is an individual, company, institution, organisation or group of organisations that takes on responsibility for initiation, management and financing (or arranging the financing) of the research.

• A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. Any delegation of responsibilities to another party should be formally agreed and documented by the sponsor.

• CNTW will consider your research project for sponsorship, we will do this by reviewing the Sponsorship Document Pack in order for us to consider the study for sponsorship.

• CNTW will review the IRAS Form and supporting documents and consider Sponsorship.

• CNTW have 3 weeks to review the sponsorship and provide feedback and comments around the sponsorship request.

As the participating site is a Non-NHS site this would not fall under the remit of HRA review and therefore would not require a model agreement/OID in place.

• There should be a PI who will have the responsibility at the participating site for the project. The overall CI can act as the PI if they work in that remit.

• If at the time of completing the IRAS Form and you have not identified a PI at this stage, the details can be left blank and this would not delay the IRAS Form validation.

If there are no costs associated with your project you will still be required to complete a SOE, this is for each site to be aware of what is it that the participants are being asked to do as part of the project.

• You will need to contact [email protected] and provide them with the HRA Approval Letter and Local Information Pack.

• R&D will review the study for capacity and capability to ensure we have the capacity to take this on. R&D will issue out an acknowledgement email to confirm if we have the support for this project.

• If you require access to the trust and need to come onto CNTW premises you will need to apply for a research passport to obtain a Letter of Access.

• The NIHR Clinical Research Network (CRN) Portfolio of studies consists of clinical research studies that are eligible for support from the NIHR CRN in England.

• Further information on NIHR Portfolio adoption can be accessed here.

Please visit the NIHR Website to identify whether your study is portfolio eligible.

• CNTW will review the amendment at site level, the R&D department will require the locked amendment tool which has been signed off by sponsor. All changes that have been made to study documentation needs to be outlined in the amendment tool.

• If the amendment is amending study documents, we will need all updated documents which are version controlled and dated.

• R&D cannot issue out approval for the amendment until all regulatory approvals for that amendment are in place.

• If the amendment tool does not outline all changes which are being made CNTW can reject the amendment and this may not be implemented at site.

• If you plan on extending your study end date R&D will require a locked amendment tool which has been signed by Sponsor.

• Regulatory approvals for the amendment need to be in place before R&D can issue out the approval for the amendment

• Email confirmation from the sponsor must be provided to R&D, we will review this and confirm whether we can support the amendment.

• The recruitment end date cannot go beyond the study end date.

• An amendment is required to change the PI or Local Collaborator, you can do this by using the Amendment Tool, select the PI option on the tool. This will then be categorised as a non-substantial no study wide review required amendment.

• This should be submitted to the participating site so they can review the amendment and confirm whether they can support the amendment.