The protocol synopsis as your operational roadmap
Use the protocol synopsis to create an operational roadmap that guides feasibility decisions and study start-up planning.
You have 20 minutes before the PI meeting
You have a meeting with the principal investigator in 20 minutes. The full protocol is 380 pages. The synopsis is 12. One of these is getting read before that meeting.
This is not a hypothetical. It is a Tuesday. The sponsor sent the protocol to the site last Thursday. The investigator has been in clinic all week, has not read the protocol, and wants to discuss whether the study is worth pursuing before the feasibility call on Friday. You, the coordinator, have been through the full operational review -- you spent six hours with the protocol on Monday, and you have your visit maps, your complexity assessment, and your red flag analysis. But the investigator does not want six hours of analysis. The investigator wants the operational picture in a format that fits between patients.