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Adding New Sites & Investigators

CTIMPs

The addition of new sites or changes of principal investigator are substantial amendments requiring a favourable opinion from the main NHS REC.  

If the site was not included in the list of proposed trial sites in the original NHS REC application, then sponsors (or their representatives) must submit the European Commission Notification of Amendment Form to the main NHS REC only. There is no requirement to notify the MHRA.

If the new site or principal investigator is within the NHS or Health and Social Care (HSC) in Northern Ireland, the main NHS REC will confirm a favourable opinion within five working days on condition that permission is given by the R&D office at the site. There is no need to submit a Site-Specific Information (SSI) Form to a local NHS REC for Site-Specific Assessment (SSA).

If the new site or principal investigator is outside the NHS / HSC, you should submit the SSI Form to the relevant local NHS REC for SSA, together with the supporting documents listed in the checklist for non-NHS site SSA in IRAS. The 35-day clock for review of the amendment starts when both a valid application for SSA and the notice of amendment have been received.

The main NHS REC will acknowledge receipt of the notice of amendment. The local NHS REC will acknowledge receipt of a valid application for SSA and will notify the main NHS REC whether or not there is any objection and the main NHS REC will then issue an opinion to the chief investigator within 35 days. A copy will be sent to the sponsor and the MHRA will be notified by NRES so that it has an up-to-date list of all approved trial sites in the UK.

All other research

If the new site or principal investigator is within the NHS or Health or Social Care (HSC) in Northern Ireland, there is no need to notify the main REC or apply for SSA to a local REC.

All NHS sites and investigators are approved as part of the favourable opinion for the study on condition that permission is obtained from the R&D office for the site.

If the new site or principal investigator is outside the NHS / HSC, the procedure depends on whether the study requires Site-Specific Assessment (SSA). Studies normally require SSA if they are medical device studies, other clinical trials or investigations, or studies involving adults lacking capacity to consent for themselves. The main REC may exempt some studies or individual sites from SSA in certain circumstances. Please check with the main NHS REC if you are unsure whether SSA is required.

If the study requires SSA, you should submit the SSI Form for a new non-NHS site to the relevant local NHS REC for SSA, together with the supporting documents listed in the checklist for non-NHS site SSA in IRAS. (It is not necessary to submit a notice of substantial amendment to the main NHS REC.) The local REC will acknowledge receipt of a valid application for SSA. It will undertake the SSA and notify the main NHS REC within 25 days whether or not there is any objection. The main NHS REC will then issue an opinion to the chief investigator within 35 days. A copy will be sent to the sponsor.

If the study does not require SSA, the sponsor may add the new site or principal investigator as soon as the study has permission from the organisation responsible for the site. There is no need to notify the main NHS REC or apply for SSA. All sites and principal investigators are deemed to be approved within the terms of the favourable opinion from the main NHS REC.

For further information please see NHS HRA: Adding New Sites and Investigators.