The Schedule of Assessments
Part of Research Nurse (RN) Training: Reading the Protocol Like a Nurse.
About 2 minutes. Free, in your language, no account needed.
Why this matters
The schedule of assessments is the table you will use more than any other page. It is the visit, laid out.
Learning to read it quickly is a practical skill. Misreading it is one of the most common causes of missing data.
How to read it
Columns are visits. Rows are procedures. A mark in a cell means that procedure happens at that visit.
Three things people miss.
Footnotes. Almost every real requirement lives in a footnote. Fasting, timing relative to dose, which arm the blood pressure is taken on.
Conditional rows. Some procedures only apply to a subgroup, or only if something else happened. A pregnancy test for participants of childbearing potential, for example.
Unscheduled visits. The table shows planned visits. It rarely shows what to do when a participant comes in unexpectedly, which is when you most need to know.
Windows
Most visits have a window. Day 15 might mean Day 15 plus or minus two days.
A visit inside the window is on time. A visit outside it is a deviation, even by one day, and it must be recorded as one.
Windows are not padding. They exist because the science can tolerate that much variation and no more. Treating a window as a target rather than a limit is how sites drift.
In practice
A participant can only come on Day 18 and the window closes on Day 17.
You do not quietly record it as Day 17. You book the visit, perform it, and record the deviation with the reason. A recorded out-of-window visit is usable data with a known flaw. A disguised one is unusable data that nobody knows is wrong.
What this looks like when it goes wrong
A site treats windows as guidance and books for convenience. Visits drift two or three days late, consistently, in the same direction.
Individually each is minor. Together the exposure period for the whole cohort is longer than the protocol specified, and the pharmacokinetic analysis is measuring a different schedule from the one under study.
No single visit caused it. The pattern did.
Key takeaways
- The footnotes carry the real requirements.
- A window is a limit, not a target.
- An out-of-window visit is usable if recorded, unusable if disguised.
- Know what to do when a participant arrives unscheduled.