Reading a Protocol Like a Data Manager

The 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.