Visit instructions and the subject booklet

Step-by-step checklists for every study visit, and a printable booklet for participants.

Visit instructions turn your protocol's Schedule of Assessments into something a study coordinator can hold in their hands: one checklist page per visit, with every test and procedure listed in order, plus tick-boxes, signature lines, and space to record results. Trelice builds the whole document for you, and can also print a subject booklet — a personal copy resolved for one participant.

Creating visit instructions#

1. Open your protocol in the editor and click the Documents button at the top-right.
2. On the Document Generation page, click the card named Visit Instructions.
3. What you'll see: a small window titled Visit Instructions. Existing documents are listed at the top. Below them, under Generate from the Schedule of Assessments:, is a dashed button.
4. Click New Visit Instructions.
5. What you'll see: the button says Generating…, then the visit instructions editor opens.

Everything is derived from the Schedule of Assessments — the table in your protocol that says which test happens at which visit. See Filling in structured sections. If the schedule is empty, the document will have little in it.

Reading the editor#

At the top is the document title, its version, and a row of buttons: Regenerate, Subject booklet, PDF, DOCX, and Print. The note beside the title explains the format: "Choose-your-path workbook — the printed PDF carries the real page numbers."

Down the left side is the section list. The first section is the flow chart — the "router" — and after it comes one section per visit. Each entry shows a status badge (DRAFT, IN REVIEW, CHANGES REQUESTED, or APPROVED) and, if you have changed it by hand, a purple edited tag.

The router page#

The router is the first page of the printed workbook. It is headed WHICH VISIT IS THIS? and lists every visit with a go to page button. On paper, the coordinator finds today's visit and turns to its page; on screen, clicking go to page jumps to that visit's section.

Question pages and worksheets#

Some studies do different things for different participants — for example, an extra test only for participants in one group. Trelice handles this with choose-your-path pages:

• A question page asks one yes/no question about the participant and says where to go for each answer.
• A worksheet page is the final checklist. It is deliberately unconditional — it says so in large letters: DO ALL OF THE FOLLOWING — NOTHING ON THIS PAGE IS CONDITIONAL. Each numbered item has a tick-box, any special instructions, and lines for the result, date, and signature.

Every worksheet also ends with two standard safety blocks — ADVERSE EVENTS and CONCOMITANT MEDICATIONS — because good clinical practice requires both to be assessed at every visit, whatever the schedule says.

Editing a visit's actions#

Open a visit section and find the box titled Actions at this visit.

1. Click Add action to add a procedure, or the pencil icon beside an existing one to change it.
2. Fill in the action's name (for example "12-lead ECG"), its category, any special instructions (fasting, timing), and tick Mandatory if it must never be skipped.
3. Click Save. Click Cancel to discard the edit. The trash icon removes an action.

Note: As the box explains, "Editing marks this section as manually edited (it will diverge from the protocol until regenerated). Routing questions update on Regenerate." Edited sections carry the purple edited tag so everyone can see they differ from the schedule.

Below the actions is Site notes (optional) — a free box for site-specific reminders. Type your note and click Save notes; notes also save automatically as you work.

When the protocol changes#

If the Schedule of Assessments changes after the document was generated, an amber banner appears: "The protocol's Schedule of Assessments has changed since this document was generated. Click Regenerate to refresh (manually edited sections are preserved)." Clicking Regenerate rebuilds the document from the current schedule while keeping your hand-edited sections.

Review#

Each section has a Review box at the bottom, working like every other review in Trelice — see Sending a section for review.

1. Choose a workflow next to Review workflow: (or keep Tenant default).
2. Pick a colleague in the Add reviewer… list and click Add.
3. Click Submit for review. The section locks while reviewers decide with Approve or Request changes. See Reviewing and approving.

Sections can also be translated: the Translations box below the review offers Add language… (Spanish, French, German, Japanese, Portuguese) and an auto-translate link per language.

Exporting and printing#

Click PDF or DOCX to export the full workbook — the file is prepared in the background and downloads when ready. See Downloading PDF and Word documents. The Print button prints the pages as shown on screen.

The subject booklet#

The workbook covers every possible path. The subject booklet collapses it for one participant: you answer the routing questions once, and Trelice prints a booklet with exactly one worksheet per visit — no questions, no branches, nothing to decide at the visit.

1. Click the blue Subject booklet button at the top of the editor.
2. What you'll see: a window titled Generate subject booklet. An amber note reminds you: answer for one subject, then print the booklet and write the Subject ID on the paper — no subject identifier is entered or stored in Trelice.
3. For each question shown, click Yes or No for this participant. If the document has no routing questions, the window says every subject gets the same booklet — just generate it.
4. Next to Format, choose PDF or Word (.docx).
5. Click Generate & download.
6. What you'll see: the file downloads to your computer. Print it, write the Subject ID on it by hand, and it is ready for the participant's visits.

Troubleshooting: If Generate & download is gray, the note below it says why: "Answer every question to continue." — every yes/no question must be answered first.