Substantial Amendment: Protocol v5.0 Launch

The Add-Aspirin Trial is pleased to formally notify sites of the Substantial Amendment for Protocol version 5.0 and updated participant materials.

From 24th March 2017 all sites can continue to work to v4.0 of the protocol and supporting documents, but will be expected during the following
4 weeks (deadline 28th April 2017) to complete and submit the amendment documentation (which can be found here) to the Add-Aspirin trial team at mrcctu.add-aspirin@ucl.ac.uk.

Sites who have submitted all of the required documents by the 28th April 2017 will be activated to v5.0 of the protocol and new participant documents. A Green Light e-mail will be sent to confirm all activation requirements have been met.

A temporary suspension to recruitment will be put in place for sites that have not submitted their documentation within this time frame and this will remain until all activation documentation has been received. This means new patients will not be able to be registered on the online system.

Please note, you will still be able to randomise existing recruited patients, however recruitment of new patients will be suspended.

Please contact the Add-Aspirin trial team if you require any assistance with the return of the substantial amendment documentation.