Use the Health Research Authority’s Decision Tool. This tells you if your study is research as defined by the UK Policy Framework for Health and Social Care Research.

If your study is research, please contact research@cntw.nhs.uk.

If your study is not research, contact the relevant team at CNTW who can offer advice:

The Health Research Authority (HRA) is an arm's length body of of the UK’s Department of Health. The HRA provides a unified national governance system for health research.

The HRA ensure all research is ethically reviewed and approved. It oversees a range of committee and services. They promote transparency in research. They also provide independent recommendations on processing of identifiable patient information where it is not always practical to get consent.

The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals for Health and Social Care and Community Care Research in the UK.

IRAS enables you to enter project-specific information once, instead of entering it lots of times across many forms.

You can use filters to ensure all data collected and collated is appropriate to your research project. It helps you make sure you get all the correct permissions and approvals.

A Principal Investigator (PI) is the person responsible for the conduct of the research at a research location. There should be one Principal Investigator for each research location.

A Chief Investigator (CI) is an individual who is responsible for the conduct of the whole research project across the UK. The Chief Investigator will have a contractual arrangement with the Sponsor organisation.

All research studies running through CNTW will need a local Principal Investigator (PI).

This should be someone who is a specialist in the research area, and is either:

  • employed by CNTW, or
  • not employed by CNTW, but holds a clinical contract with CNTW.

All research projects running through CNTW will also need a Chief Investigator (CI). They are responsible for the conduct of the whole project across the UK.

For CTIMPs

You will need to make a modification of an important detail minor modification to change the PI. You can do this using the Modification Tool. Select the ‘Key project roles – Change of Principal Investigator’ option on the tool. Then submit this to your Sponsor for review.

Once the Sponsor has approved the modification, circulate this to the relevant participating location(s).

For non-CTIMPs:

Add the changes to the PI or Local Collaborator to a modification tool. Then submit this to your Sponsor for authorisation. This will be a non-notifiable modification. This means you do not need to submit it to HRA/REC for approval. You can share it directly with the relevant participating location(s).

Yes. There should be a PI responsible for each participating location for the project. The Chief Investigator can act as the PI if they work in that remit.

You should identify a PI for each research location before you submit your IRAS for approvals.

No. Non-NHS locations would not fall under the remit of HRA review. So, they would not need a model agreement/OID.

If there are no costs associated with the project, you don’t need a SOECAT.

But you do need an SOE if your study has multiple research locations. This document tells each location what the participants are being asked to do as part of the project.

You will need to send the HRA Approval Letter and Local Information Pack to research@cntw.nhs.uk.

We will review your study to ensure we have the capacity to take this on. We will send you an acknowledgement email to confirm if we have the support for this project.

If you need to visit CNTW premises, you will need to apply for a Research Passport to get a Letter of Access.

The National Institute for Health and Care Research (NIHR) Research Delivery Network (RDN) Portfolio is a list of high-quality research studies that are eligible for support from the NIHR RDN. Find out more about the NIHR RDN Portfolio.

To access NIHR RDN support in England, and be included on the Portfolio, studies must meet the eligibility criteria.

We will review the modification at location level. We will need the locked modification tool which the study sponsor has signed off. The modification tool needs to outline all changes that have been made.

If the modification changes study documents, we will need all the updated documents. (These must be version controlled and dated.)

We cannot approve the modification until all regulatory approvals for that modification are in place.

If the modification tool does not outline all the changes, we can reject the modification. This means it may not be implemented at our location.

If you plan on extending your recruitment or overall study end date, we will need a locked modification tool which the study sponsor has signed off.

We cannot approve the modification until all regulatory approvals for that modification are in place.

We will review this and confirm whether we can support the modification.

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