Addition of New Sites & Investigators 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.
For Clinical Trials of Investigational Medicinal Products (CTIMPs), adding a new trial site* or a change of Principal Investigator at a site constitutes a substantial amendment (see Substantial Amendment station) requiring notification to the ethics committee. For UK trials, this substantial amendment does not have to be sent to the MHRA.
The HRA web pages outline the requirements for CTIMPs conducted in NHS and Non-NHS organisations. The HRA Standard Operating Procedures for Research Ethics Committees (Section 5) provide information on the definition of a research site (including examples that do not meet this definition, such as Patient Identification Centres PICs).
One of the standard conditions for ethics committee approval (for all research) is that the sponsor must obtain NHS permission (R&D Management approval) from the relevant host organisations prior to the start of the study at each site (see R&D Submission station).
For non-CTIMP research, the addition of a new site or Principal Investigator is not considered a substantial amendment. However the HRA web pages (all other research) give guidance on when site specific assessment is required for non-NHS sites.
All changes to sites and / or investigators should be communicated to the Funder at the earliest opportunity.
*Sites that were listed as potential sites on the original ethics application do not need to be submitted as a substantial amendment.