Guided Notes
Reading a Protocol Like a Data Manager
Protocol sections that drive data collection — objectives and endpoints, schedule of assessments, visit windows, eligibility, safety reporting — and turning them into a data collection plan.
Why the protocol is your blueprint
Slide 1 / 5The protocol defines what data must be collected, when, and why. Every eCRF, edit check and listing should trace back to it. Data managers read the protocol looking for: • endpoints (what must be measured precisely), • visits and procedures (what happens when), • eligibility rules (what to check), • safety reporting rules (what's an AE/SAE, timelines), • anything ambiguous that will confuse sites.