The Site Initiation Visit (SIV) is required to prepare and set up a research site to conduct a study and must occur prior to patient recruitment. The principal investigator (PI) must attend this visit together with as many members of the research team as possible.
Representatives from any supporting departments should also attend where possible e.g. pharmacy, radiology, laboratories.
If NBT have agreed to sponsor your study, it is recommended that they are required to attend the SIV. Please provide the Research & Innovation Office advance notice of the date for the SIV to ensure attendance.
The role of this meeting is to discuss the protocol, especially the inclusion/exclusion criteria,study procedures, and the research participant pathway The sponsor will discuss the monitoring plan for the study – including safety reporting procedures and monitoring to Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) requirements.
When conducting the site initiation visit (SIV):
- Review the protocol in detail
- Review instruction on any specialised procedures such as diagnostic tests and special computer programs
- Receive direction for Case Report Form (CRF)/electronic CRF completion & safety reporting
- Define source documents
- Be prepared to provide sponsor with an update on any study related
- Document all study related training
- Review the Investigator Site File