From a former coordinator
Field notes.
How visit windows actually get calculated, what to do when one is missed, and how a small site runs a visit: what gets done, in what order, by whom, and where. Written by a CRC who kept the shadow spreadsheet too.
- I used CRIO for three years, then RealTime. Here is when a spreadsheet was still enough.
An honest map for small research sites. What a CTMS actually does, when a spreadsheet is enough, when it isn't, and what "free CTMS" really means.
September 10, 2026 · 9 min read
- Day 0 or Day 1? Why your Week 4 visit lands on Day 29
Some protocols call the first-dose day Day 0, some call it Day 1. Both put Week 4 four weeks out. Mixing them shifts every window by a day.
September 10, 2026 · 8 min read
- Trained first, or delegated first? What an inspector actually checks
Delegation date and training date both on or before the first task, training first. What FDA, ICH E6(R3) and MHRA require, and the check a monitor runs.
September 10, 2026 · 7 min read
- The visit was missed. Which date do you count from now?
After a missed or late visit, the protocol decides whether the next window counts from the anchor date or the last actual visit. How to tell, with 2026 dates.
September 10, 2026 · 9 min read
- Out-of-window visit: is it a deviation, and how do I write it up?
What out of window means in dates, when it is a reportable deviation, the call to make before the visit, and a note-to-file skeleton you can copy.
September 10, 2026 · 9 min read
- What happens at Week 4, in what order: the visit checklist
A study visit checklist is the task list beside the source worksheet. What gets done at Week 4, in what order, how your site does it, where, and by whom.
September 10, 2026 · 8 min read
- Who can do what at a study visit: MAs, vitals, sub-Is, and standard of care
Can a medical assistant take vitals or draw blood in a clinical trial? The three gates every procedure passes, a role matrix, and the standard-of-care rule.
September 10, 2026 · 8 min read