Writing and formatting text

Making text bold, adding lists and headings, and inserting abbreviations.

Some parts of a protocol are ordinary prose: the References and Appendices sections, and the Additional Notes (optional) panel at the bottom of every form section. These use Trelice's text editor, which works much like a very simple word processor. This guide covers its toolbar, and how to insert abbreviations so they are expanded correctly in the finished document.

If the section you opened looks like a form with labeled boxes rather than a blank page, see Filling in structured sections instead.

The toolbar#

The toolbar sits in a gray strip across the top of the text area. Its buttons are plain labels, not pictures. From left to right:

• B — makes the selected text bold. Select the words first, then click.
• I — makes the selected text italic.
• U — underlines the selected text.
• H1 — turns the current line into a large heading.
• H2 — turns the current line into a smaller heading.
• • List — starts a bulleted list, or turns the selected lines into one.
• 1. List — starts a numbered list.
• Abbr. — inserts an abbreviation (explained below).
• Undo — takes back your last change. You can click it several times.
• Redo — restores what you just undid.

A button is highlighted while its formatting is active. To switch formatting off — for example to stop a list — click the same button again.

What you'll see: at the bottom left of the editor, a live word count such as "312 words" updates as you type. Your work saves automatically — see saving in the editor overview.

Note: the toolbar only appears while the section is editable. If the section is in review or approved, the toolbar is hidden and a gray bar explains why.

Inserting an abbreviation#

Protocols are full of abbreviations — AE, CBC, ECG. Regulators expect each one to be spelled out at its first mention and listed in the Abbreviations and Definitions section. Trelice does both for you, but only for abbreviations you insert, not ones you simply type.

1. Place your cursor where the abbreviation should go.
2. Click Abbr. in the toolbar.
3. A panel opens with a search box that says "Find or create an abbreviation...". Type a few letters.
4. Matches appear in up to three groups: In this protocol (already used here), Organization library (your organization's shared list — see Abbreviations, redaction, and budget pricing), and Standard (ICH/GCP) (the built-in industry set).
5. Click the one you want. It is inserted at your cursor and attached to this protocol.

What you'll see: the inserted abbreviation appears as a small tinted chip in your text — slightly shaded, so you can tell it apart from ordinary typing. In the exported PDF or Word document it prints as normal text; the very first mention in the document is expanded automatically, for example "adverse event (AE)".

Creating a new abbreviation#

If nothing matches what you typed:

1. Click Create "…"... at the bottom of the list.
2. Type the definition — the panel prompts "Define" followed by your abbreviation, with an example such as "e.g. adverse event".
3. Leave the box "Also add to the organization library" ticked if colleagues should be able to reuse it in other protocols.
4. Click Add and insert.

Troubleshooting: if the panel says "An abbreviation cannot contain spaces or braces.", shorten what you typed to a single unbroken term, such as "PK/PD".

Abbreviations in form fields#

Ordinary text boxes in form sections offer the same feature. Rest your mouse near a text box and click the small letter icon beside it (its tooltip says Insert an abbreviation). A marker is placed in the box, and a gray line underneath shows "Renders as:" followed by how it will read in the document.

Keeping the abbreviation list honest#

The Abbreviations and Definitions section of the protocol is not typed by hand. Open it and you will see two panels:

• In the document — abbreviations actually used in the protocol. These print in the exported list, and the note explains: "The first mention of each in the document is expanded automatically."
• Defined but not used — an amber panel listing abbreviations attached to the protocol but not mentioned anywhere. These will not appear in the exported list. Remove each one with the trash icon, or go and use it in a section.

You can change a definition with the pencil icon. If your organization's library has since updated a definition, an amber note reads "The organization library has a newer definition." with a Use it link to adopt it — every occurrence in the protocol updates at once.

Note: typing an abbreviation as plain text — just pressing the letters A and E — does not link it. The document will not expand it, and it will not appear in the exported list. When in doubt, insert it with Abbr. or the letter icon.