Governance

For Clinical Trials of Investigational Medicinal Products (CTIMPs), you will need to seek approval via combined review.

This is where you make a single application using a new combined application for IRAS, which goes to both the Medicines and Healthcare products Regulatory Agency (MHRA) and a Research Ethics Committee (REC) at the same time. For more information, visit the HRA website.

You can also find out about the application here.

Your study which involves patients will need Research Ethics Committee (REC) approval via the Health Regulatory Authority (HRA), and / or Medicines and Healthcare products Regulatory Agency (MHRA) approval.

For sponsorship, site indemnity and confirmation of Capacity and Capability (C&C), please contact the relevant Research & Development department (KCH or SLaM).

The NIHR King’s CRF is categorised as a KCH site when your study involves any of the below:

• King’s College Hospital NHS Foundation Trust (KCH) patient
• KCH Principal Investigator (PI)
• King’s College London (KCL) PI with a KCH contract

The NIHR King’s CRF is categorised as a SLaM site when your study involves any of the below:

• South London and Maudsley NHS Foundation Trust (SLaM) patient
• SLaM Principal Investigator (PI)
• King’s College London (KCL) PI with a SLaM contract

If your study involves healthy volunteers/non-NHS subjects, and includes any of the below, the NIHR King’s CRF is categorised as either a KCH or SLaM site:

• CTIMP
• Ionising radiation involved
• Non-CE marked device
• Principal Investigator who has a substantive or honorary contract with KCH or SLaM

These studies will need Research Ethics Committee (REC) approval and / or Medicines and Healthcare products Regulatory Agency (MHRA) approval.

You will also need to contact the relevant R&D department for sponsorship, site indemnity and confirmation of Capacity and Capability (C&C).

If your study involves healthy volunteers/non-NHS subjects, and includes any of the below, it will be categorised as either a KCH or SLaM site (depending on the PI),  and will need ethics approval from King’s College London.

• Non-ionising radiation, e.g. MRI
• Blood sampling
• Questionnaires/interviews
• Administration of drug/substance (non-IMP) or surgical intervention

The NIHR King’s CRF is categorised as a KCL non-NHS site and therefore needs ethics approval from King’s College London when your study involves healthy volunteers/non-NHS subjects and includes any of the below:

• Non-ionising radiation, e.g. MRI
• Blood sampling
• Questionnaires/Interviews
• Principal Investigator with substantive King’s College London (KCL) contract and KCL students

All users of the NIHR King’s Clinical Research Facility (CRF) must have an appropriate contract in place and attend a CRF induction before any research can take place in our facilities. You can read more about these on the training and development section of our website.