The Substantial Amendment station follows the Addition of New Sites & Investigators station and precedes the Urgent Safety Measures station. This process occurs in parallel with Safety Reporting, Progress Reporting, Ongoing Management & Monitoring, and GCP & Serious Breach Reporting. It also has the potential to occur simultaneously with an MHRA Inspection, Audit, Addition of New Sites & Investigators, Urgent Safety Measures, Temporary Halt, and Early Termination. Substantial Amendments are a legal requirement which is relevant to all trials. This station is part of the ‘recruitment phase’ group of stations.
Amendments are changes made to a research project after approval from a review body has been given. For amendments to projects conducted at NHS/HSC sites, guidance can be found on the Integrated Research Application System (IRAS).
Amendments are now prepared using the Amendment Tool (V1.5). The Tool will automatically assign a recommended amendment category based on each type of change made as part of the amendment. It is the sponsor’s responsibility to ensure the Amendment Tool is completed correctly, and to confirm the outcomes align with their own expectation of how the amendment should be processed. The completed amendments should be submitted as directed on the ‘Submission Guidance’ tab in the Amendment Tool.
*Note: The amendment tool can now be used to notify the MHRA of substantial amendments in place of the Annex 2.