Field notes
What happens at Week 4, in what order: the visit checklist
The schedule of assessments says which procedures. It does not say the order, the room, or who. Here is the checklist that does, with a worked Week 4.
A study visit checklist is a list of what gets done at one visit, in the order it gets done, with enough detail that a coordinator who has never run the visit could run it. It is not a case report form and not a source document; it is the task list beside them. The schedule of assessments is not a checklist either. It says which procedures happen at Week 4. It does not say that the questionnaire comes before the blood draw, that the pregnancy test is read before the dose, which room, or who on the delegation log may do it today. Here are the ordering rules, a worked Week 4, and a skeleton to copy.
What a visit checklist is, and what it is not
UAB's coordinator training defines it best, in a two-page handout called Using the Protocol to Create Visit Checklists: "A list of visit-specific tasks, activities, and procedures to be conducted before, during, and after the visit. The visit checklist is not a case-report form (CRF) or source document. It is a tool to be used by coordinators/study staff to ensure required procedures have been completed and visits are conducted in an orderly and logical manner and per the protocol."
It is not source. The blood pressure reading goes on the source worksheet; the tick that says "vitals done" goes on the checklist. A checklist that holds values is a second, unofficial source document, and now two places can disagree about one number.
It is ordered. UAB says tasks "should be listed in order of occurrence." The SoA is a grid of X marks, and a grid has no order.
It is for the person who is not you. UAB calls it "useful for back-up coordinators." That is the test: hand it to whoever covers your vacation and see whether she can run Week 4 without calling you.
Why the schedule of assessments is not a checklist
The SoA answers one question, at which visits does each procedure happen. It cannot tell you the order. The NIH-FDA protocol template (NOT-OD-17-064) asks the SoA to state the visit windows, and it does; the sequencing lives in footnote k, section 8.2.3, and a sentence in the pregnancy-testing chapter. It cannot tell you the room, or the how (the sponsor does not know your OCT signal drops unless the subject was dilated twenty minutes ago), or the who, because the delegation log is a site document. UAB's line: "The protocol SoA should not take the place of a visit checklist."
The ordering rules, and the reasoning behind each
Your protocol governs; where it is silent, your site's SOP does. This is what protocols usually say, and why.
- Questionnaires first, before anyone talks to the subject. A patient-reported outcome collected after the investigator has said "your labs look great" is a different measurement. One current AstraZeneca protocol: "The PRO questionnaires must be completed before any other study procedures are conducted, including being seen by the investigator," with the reason in the SoA footnote, "To avoid bias in patient responses" (AMETHYST, D5496C00005).
- Fasting labs before anything that ends the fast. Usual reasoning, not a quote: the subject has fasted since midnight, so the draw goes as early as the order allows.
- Vitals and ECG before the needle. The same AstraZeneca protocol specifies "Vital signs (to be taken before blood collection for laboratory tests)." The ECG follows the same logic, and that part is the usual reasoning: a resting ECG five minutes after a hard stick is not a resting ECG. UAB's sample flags the detail: "supine BP required."
- Pregnancy test read negative before the dose. Not collected before; read before. UNC's research SOP states the requirement for a known or suspected teratogen as a "negative pregnancy test (urine or serum) confirmed prior to each study drug administration" (UNC OHRE SOP 4801). The result goes on the worksheet, then the drug comes out of the fridge.
- Clinician assessments by someone qualified to rate them. UAB's sample notes "each assessment requires rater qualification." That is an ordering rule in disguise: the rater has to be in the building when the assessment is due.
- Investigational product last. UAB's sample runs PROs, con meds and AEs, vitals, labs and UPT, ECG, assessments, exam, drug accountability, and only then "Dispense IP" and "Administer dose in clinic." Everything above the dose is a check that has to pass first.
- Timed observations count from the dose, not from arrival. Write the clock start on the checklist.
A worked Week 4
I will use the sample schedule that ships with CRC Run Sheet. Week 4 is Day 28, window plus or minus 3. Subject 012 was randomized Monday, March 2, 2026, so Week 4 targets March 30, window March 27 to April 2. Say it is a retina study: an intravitreal injection, OCT imaging, a pressure check afterward. Her Week 4, in four columns:
| What | How your site does it | Where | Who is delegated |
|---|---|---|---|
| Symptom questionnaire | On the tablet, before check-in; nobody helps with the answers | Waiting room | Coordinator |
| AE and con-med review | Open question first, then last visit's list | Exam 1 | Coordinator |
| Vitals | Seated, 5 minutes rest, before any draw | Exam 1 | Coordinator |
| Urine pregnancy test | Read and written on the worksheet before the injection kit is opened | Lab bench | Coordinator |
| Dilate | 20 minutes before imaging; drops are in the Imaging 2 fridge | Exam 1 | Coordinator |
| OCT capture | Macular cube, both eyes, study eye first; repeat if signal is under the protocol's floor; upload same day | Imaging 2 | Photographer, OCT on the signed DOA log, certification current |
| Intravitreal injection | Unmasked staff only | Procedure room | PI |
| Post-injection IOP check | 30 minutes after the injection; clock starts at injection time | Exam 1 | Ophthalmic tech, IOP on the DOA log |
| Schedule Week 8 | Target April 27, window April 22 to May 2 | Front desk | Coordinator |
The first column is the protocol. The second is your site. The third is a building the sponsor has never seen. The fourth is a document the PI signed.
The four columns every line needs
What. The procedure as the protocol spells it, so it matches the SoA and the CRF page: the protocol layer, new every study.
How your site does it. The steps the protocol assumes you know and the ones your site learned the hard way: the rest period, the machine preset, which fridge. This is where the back-up coordinator lives or dies.
Where. A room, not a department. "Imaging" is a department; "Imaging 2" is where the subject walks.
Who is delegated. Not who usually does it: who is on the signed delegation log for this task, with training current on the day. A task done before the person was delegated for it is a finding about a date, and the checklist is where to catch it the morning of. The order those two dates have to fall in is its own post: trained first, or delegated first.
Why the site layer should carry to the next study
Count how many cells in that table would change if the same site opened a second retina study next month: the what column, the window, the section numbers. The rest is your building.
Coordinators on r/clinicalresearch put it at "80% the same" when describing rebuilding source worksheets in Word for each new study (the thread). The same 80% applies to checklists, and UAB's "useful for back-up coordinators" is really about turnover: the coordinator who replaces you is a back-up who never got the handoff.
So write the site's how-to per procedure, not per study. A new protocol should start with the OCT line already written and only the protocol layer blank; in Word, that means a site master you copy from, not last study's checklist with the names changed.
A checklist skeleton you can copy
Plain text so it pastes anywhere. It is a task list, not the source record; values go on the worksheet.
STUDY VISIT CHECKLIST — a task list, not a source record; values go on the worksheet.
Study: ________ Visit: Week 4 (Day 28, window −3/+3) Subject ID: ______ Date: ______
BEFORE
[ ] Reminder call: fasting? bring bottles and diary; no home dose today
[ ] Kit in date; drug at temp; tablet charged
[ ] Who is delegated today for each line below (DOA log, training current)
DURING — in this order where who
[ ] Questionnaires, before check-in conversation
[ ] AE and con-med review
[ ] Fasting draw, if any
[ ] Vitals (rest ___ min, position ______), then ECG if due
[ ] Urine pregnancy test — READ NEGATIVE before dose
[ ] Clinician assessments (qualified rater)
[ ] Site-specific procedure: ______ how our site does it: ______
[ ] Drug accountability: returns counted
[ ] Dispense / administer IP — LAST
[ ] Timed post-dose checks: ___ min after dose; dose time ______
[ ] Schedule next visit: target ______ window ______ to ______
AFTER
[ ] Samples processed and shipped; accession logged
[ ] EDC entry; lab results to PI for signatureWhere the window and the checklist meet
The window tells you when: Week 4 opens March 27 and closes April 2. On the day, the checklist takes over: what, in what order, where, by whom.
A late visit changes what is due. If Subject 012 comes in on April 9 instead, the injection is still on the list, but a PK draw tied to the dosing interval may no longer mean anything, and 28 days of drug now covers a shorter gap to Week 8. Which date the next window counts from is its own question; the checklist for a late Week 4 is not the checklist for an on-time one.
A run sheet is what this site calls a visit checklist that carries the how, the where, and the who on every line; the definition, and how it differs from a source worksheet, is at /run-sheet. Whatever you call yours, build it before the study opens, keep the values off it, and write the site's half so it outlives the study.