New HRA amendment tool

Researchers now need to use the new version of the tool, which was made available on 25 March.

Related updates for researchers on study amendments include:

• The amendment tool can also now be used to notify the MHRA of substantial amendments in place of the ‘Annex 2’ form.
• The addition of a new NHS/HSC site or a change of PI at an NHS/HSC site for a CTIMP study will now be classified as a non-substantial amendment.
• Upon submission of either a non-substantial or non-substantial, no study-wide review amendment, researchers will receive a system generated confirmation email with instructions on how to notify sites.