Recruitment Phase

Addition of New Sites & Investigators station follows the Audit station and precedes the Substantial Amendments 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, Substantial Amendments, Urgent Safety Measures, Temporary Halt, and Early Termination. Addition of New Sites & Investigators is a legal requirement which is relevant to all trials. This station is part of the ‘recruitment phase’ group of stations.

For CTIMPs conducted at NHS/HSC sites, the addition of a new site and/or addition or change of a Principal Investigator, is no longer considered a substantial amendment. This has been implemented to speed up the site set-up process. No changes have been made to the classification of amendments relating to new sites/change of PI at non-NHS sites.

If a site is added in a nation not previously involved in the project, this should be indicated at the relevant question of the Amendment Tool and made clear in the covering letter when submitting the amendment to the lead nation.

The contact details for sites in the UK (Research and Development (R&D) organisations) can be accessed from the NHS R&D forum website.

All changes to sites and / or investigators should be communicated to the Funder at the earliest opportunity.

 

Further Reading