Filling in structured sections

Sections that are forms instead of free text, including the Schedule of Assessments table.

Most sections of a protocol in Trelice are not blank pages. They are forms: labeled boxes, dropdowns, and lists, so you fill in facts instead of drafting paragraphs. Trelice then writes those facts into the finished document in the proper format. Only a few sections — References and Appendices — are free text (see Writing and formatting text).

How a form section is laid out#

From top to bottom:

1. A blue banner with a short explanation of what the section is for.
2. A progress bar with a count such as "12/30 fields", so you can see at a glance how much is filled in.
3. A stack of panels, one per topic. Each panel header shows its title and its own small count (for example "3/5"). Click a header to close or open the panel.
4. At the very bottom, a collapsible panel called Additional Notes (optional) — a free-text area for anything the form does not cover.

Inside a panel, fields come in a few shapes:

• Text boxes and larger multi-line boxes. Gray hint text inside or below a box suggests what to enter.
• Dropdowns, which start on — Select —.
• Date pickers and number boxes.
• Checkboxes, and rows of clickable choice chips where you can pick several.
• Lists: click Add item to add a row, and the trash icon to remove one.
• Cards for bigger things like study treatments: click the dashed Add … button to add a card, fill in its boxes, and use the trash icon in its corner to remove it.

A red asterisk (*) beside a label means the field is required. Some fields become required only because of the countries you chose on the Title Page — the badges described next tell you which rule is behind that.

Note: a field with a gray background is calculated by Trelice from other fields, and cannot be typed into.

The little badges beside field labels#

Next to many field labels you will see small chips. Each opens a popover when clicked; click anywhere else to close it.

• A gray chip with a tiny open book and a number — regulatory references. The popover is titled Regulatory References ("Regulations that require or govern this field") and lists each regulation with its country flag, name, and issuing body. A red Required tag means that regulation makes the field mandatory for your trial's countries. Click an entry to open the regulation text in a new browser tab. Entries shown faded apply to countries your trial does not include.
• An amber chip with a tiny lightbulb and a number — guidance. The popover is titled Guidance Recommendations ("Recommended by regulatory guidance — not a hard requirement"). These are suggestions worth following, not rules.
• An amber Threaded chip — this value is shared with other sections. See Golden threads.
• A speech-bubble chip — comments on this field. See Comments and working together.

The Schedule of Assessments table#

The Schedule of Assessments is the heart of the protocol: a table saying which test happens at which visit. Each row is a test or procedure (an assessment). Each column is a visit. A tick in a cell means: this test happens at this visit.

Above the table, a View: switch offers Table (the grid, recommended) and Form (the same data as plain lists).

If the schedule is empty you will see two buttons: Add First Visit and Add First Assessment. Start with visits.

Adding a visit (a column)#

1. Click the small Visit button with a plus sign at the right end of the header row (or Add First Visit).
2. In the Add Visit dialog, fill in Visit Name (for example "Screening") and Short Label (for example "SCR") — the label is what the column header shows.
3. Under Timing, enter the timepoint number and pick a unit and what it counts from. The hint reads: "The timepoint number itself — -28 for screening, 1 for baseline, 4 for Week 4."
4. Under Visit Window, you may enter how early and how late the visit may happen (for example -3 and +3). The ± button makes the window symmetric for you.
5. Check the gray "Displays as:" line — it shows exactly how the timing will print.
6. Click Add Visit.

If a visit cannot be described by one number ("Every 28 days"), click Use custom timing text instead and type it in words.

To change a visit later, click the small pencil under its column header. The Edit Visit dialog also has a red Delete Visit link; deleting a visit unticks it from every row.

Adding an assessment (a row)#

1. Rows are grouped by category (Laboratory, Vital Signs, and so on). Under a group, click Add assessment to that group; or click Add new assessment at the bottom of the table.
2. In the Add Assessment dialog, fill in Assessment Name (for example "Complete Blood Count (CBC)"), and optionally a Category, Special Instructions (such as "Fasting required"), and Notes.
3. Tick Mandatory assessment if it must never be skipped — the row then carries a small red REQ tag.
4. Click Add Assessment.

Then tick the boxes along the row for each visit where the assessment happens. To edit or delete a row, rest your mouse on its name and click the pencil.

Footnotes#

Real schedules carry footnotes — "Fasting for at least 8 hours.", "Women of childbearing potential only." In Trelice you never number footnotes yourself.

1. Rest your mouse on a visit header, an assessment name, or a ticked cell. A small dashed + appears.
2. Click it. A panel opens showing what the footnote will attach to.
3. Type the Footnote text, or pick an existing one under "…or reuse one already in this section".
4. Note the blue line: "Appears as N — Trelice numbers and places it; the number changes by itself if visits or rows move."
5. Click Add footnote.

What you'll see: a small blue superscript number appears at that spot, exactly as it will print. Below the table, a panel headed Footnotes in this section lists every footnote in final order ("Numbered by order of appearance"), with chips showing where each one is used. Click a footnote there to highlight its locations in the grid; use the pencil to reword it and the trash to delete it everywhere. Clicking a blue marker in the grid opens that footnote for editing; if it is used elsewhere, an amber note warns you, and Remove here detaches it from this one spot only.

Note: whether footnotes show as numbers or letters is an organization-wide setting; the numbering logic is the same either way.

The schedule feeds several other documents automatically — the site budget, the study schematic, and visit instructions — so time spent getting it right pays off many times over.