Study Initiation and Management: Addition of new study sites

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Introduction

Whether the addition of a new site needs to be notified to the main REC depends on the type of study. For studies that are classed as non-Clinical Trials of Investigational Medicinal Products (non-CTIMP) such as data studies and most tissue studies, there is no requirement to notify the main REC (i.e. addition of a new site to non-CTIMPs is classed as a non-substantial amendment).

For studies with HRA Approval led in England
Studies with HRA Approval are expected to notify both substantial and non-substantial amendments therefore whether the study is a CTIMP or not, the HRA need to be informed (see Protocol Amendments, and resources 1 and 2).

For studies led in Scotland, Wales or Northern Ireland
All amendments made during your study should be notified to all NHS R&D sites involved in your study. This applies both to substantial and non-substantial amendments. The addition of a new site may also require a Site-Specific Assessment (SSA) by NHS R&D at the new site. This should be submitted on a Site-Specific Information (SSI) form available in IRAS (3rd resource below).

When a new site is added to an SSA-exempt study the relevant NHS R&D office should be informed of the inclusion of their organisation by letter or email.

The sponsor(s) will of course need to be notified of the addition of a new site so that they can ensure that all parties are aware of their responsibilities within the study.

Be aware that the policy for adding new sites to CTIMPs differs from the above. These are outlined in the Clinical Trials Toolkit, Addition of new sites and investigators station.

Guidance for submitting amendments via IRAS for all review bodies is in the 4th resource below.

Resources