HRA Reissue of Categorisation

HRA Reissue of Categorisation - Non substantial amendment - Typographical error in the PIL date referenced on the ICF – Amendment date 02 November 2016

 The HRA have reissued the categorisation email for the above amendment, downgrading the amendment from a Category A to a Category C. Following consultation with the HRA it is apparent how this error occurred - although the amendment affects all participating NHS organisations (Category A), the amendment has no implications that require oversight by the participating organisations (Category C) due to the amendment being a typographical error. As a result the amendment has been downgraded from a Category A to a Category C. Please see detailed below the HRA category definitions, taken from the categorisation emails:

Category A - An amendment that has implications for, or affects, ALL participating NHS organisations
Category C - An amendment that has no implications that require management or oversight by the participating NHS organisations

As a result of the reissue of the amendment categorisation patients requiring reconsent to version 2.1 of the Patient Information Leaflet can complete the reconsent process ahead of any acknowledgement of the amendment from local R&D departments. All reconsents thus far have been carried out in accordance with the required regulations.

The reissued HRA categorisation email can be found in the ISF section of the website (

SPIRIT 2 Trial Team
23 February 2017

Last modified: Mon, 06 Mar 2017 14:53:01 GMT