A Site Initiation Visit (SIV) is often made at each site, organised by the sponsor and/or CI/PI. The sponsor/CI/PI is then able to confirm that all technical aspects of a trial and protocol requirements are fully understood by all relevant site staff. At this stage, trial-specific training (protocol and trial-specific procedures) as well as training on aspects of trial conduct such as Case Report Form (CRF) completion and safety reporting requirements is often undertaken. Site staff also have an opportunity to ask questions and clarify misunderstandings.
This communication should also include pharmacy (where applicable) so that they can confirm that all requirements are in place before dispensing Investigational Medicinal Products (IMPs) to subjects.
|Type||Where to find|
|Key contacts||Clinical Divisions; JRCO|
|Useful links||NIHR Clinical Trials Toolkit - trial begins
NIHR Clinical Trials Toolkit - adding new sites
JRCO - initiate study
|NIHR benchmark||Within NIHR 70-day benchmark (Day 30-end)|
|Process map links||This activity occurs in the recruitment stage:
> Imperial College London as sponsor
> Imperial College Hospital NHS Trust as sponsor
> Commercial organisation as sponsor
> Non-commercial organisation as sponsor