What is a run sheet? (for coordinators, not event planners)
The visit checklist, plus how your site does it, where, and who is delegated. The worksheet stays the source.
A run sheet is the one page you would want open when Subject 012 is in the chair for Week 4. It lists what gets done at that visit, in the order it gets done, how your site does each step, where it happens, and who is delegated to do it. It is a task list for the visit. It is not the source document, and it is not the case report form.
If you search the phrase, you get event production: the timed running order for a wedding or a broadcast. That is the same idea pointed at a different room. A study visit has a running order too. Ours just lives in a coordinator's head, a binder tab, and a spreadsheet.
What it is next to
Research sites already have three documents that touch the visit, and each one is missing something.
- The schedule of assessments says which procedures happen at which visit. It does not say the order, the room, or who. It is written for every site, so it cannot.
- The source worksheet (some sites say site worksheet, or SSD) is where the data gets written down. It is source. It is built for the monitor and the CRF, not for the person running the visit. Training programs are explicit that a visit checklist "is not a case-report form or source document" and that the schedule of assessments should not take its place (UAB CCTS, Using the Protocol to Create Visit Checklists).
- The delegation log says who is allowed to do what. It is signed and filed. Whether the tech doing today's OCT is on it, with a start date before today and a certification that has not lapsed, is a question people answer at the monitor visit. It should be a question for the morning.
A run sheet is the visit checklist with those gaps filled in. Four columns on every line:
| What | How your site does it | Where | Who |
|---|---|---|---|
| Urine pregnancy test, before the injection | Dipstick from the Imaging 2 fridge; result in the worksheet before IP is drawn up | Exam 1 | J. Okafor, CRC, on the log |
| OCT capture, both eyes, study eye first | Heidelberg, 512×128 preset; dilate 20 minutes before; upload to the reading center same day | Imaging 2 | M. Reyes, photographer, cert renews in 41 days |
| Post-injection IOP, 30 minutes after | Tonometer in Exam 1; note the time | Exam 1 | R. Chen, ophthalmic tech |
The first column comes from the protocol. The other three are yours. They are the part a new coordinator cannot get from the protocol, and the part that is lost when a study closes and the binder goes to storage.
Why "run sheet" and not "checklist"
Because the how, the where, and the who are the point. A checklist ticks. A run sheet runs the visit. It is also the word for what prints: the sheet you hand to the back-up coordinator on the day you are out, or to the tech who has never done this study's OCT before.
The site layer should carry forward. Your dilation step, your fridge, your reading-center upload routine are the same on the next retina study. Writing them once, per site, and attaching them to each new protocol's schedule is the whole trick. It is what the visit checklist post walks through with a worked Week 4.
What it is not
It is not source. Nothing on a run sheet replaces the worksheet, the chart, or the CRF, and if a run sheet ever starts to look like a source record it is being used wrong. It is not a regulatory binder, not eSource, not a system of record, and it makes no 21 CFR Part 11 claims. It is the aid you keep beside those things so that the visit goes in the right order, in the right room, by the right person, inside the window.