
Receiving a new protocol: what to look for in the first 48 hours
Learn the systematic approach to reviewing a new protocol in the critical first 48 hours, identifying key operational requirements and potential challenges.
A 400-page protocol lands in your inbox at 4:17 PM on a Friday
It arrives without ceremony. An email from a clinical research associate at a contract research organization, addressed to the principal investigator with you copied, containing a PDF attachment of 412 pages. The subject line reads: "Protocol [STUDY-XXX-001] v2.0 -- Confidential -- Feasibility Review." The message is polite and efficient. The sponsor would like an initial feasibility response by Wednesday.