
During the SIV: your role, your questions, and what to document
Identify the six critical information domains that must be captured during the SIV, formulate operational questions the CRA may not cover unprompted, and document the visit for team reference.
One hundred and twenty-seven slides, and the PI is checking email
The monitor opens the laptop, connects to the projector, and advances to the first slide of a deck that--according to the slide counter in the lower right corner--contains 127 slides. The investigational product handling section alone accounts for 34 of them. The pharmacist is writing furiously, trying to capture storage temperature ranges and accountability log procedures. The principal investigator, who has done this before, is scanning email on a phone beneath the conference table. Two sub-investigators in the back row are whispering about a patient on the ward. And you--the coordinator--are sitting in the middle of it all, absorbing information that you will need at 7:00 AM on the morning the first participant arrives for a screening visit.