The protocol editor at a glance

The protocol's sections, the colored status icons, saving your work, and the editor's toolbar buttons.

The protocol editor is where a protocol gets written. You reach it by opening a study and then opening its protocol — see Working with studies. This guide is a tour of the screen. Once you know your way around, the guides on writing text, structured sections, and sending a section for review cover the work itself.

The screen has two main parts: a list of sections down the left side, and the editing area filling the rest.

The section list on the left#

At the top of the left panel you will see the protocol's title and its version number (for example "v1.0"). Below that is a bar labeled Required sections with a count such as "8/14". The green bar fills as required sections gain content.

Under the bar is the list of sections. A standard protocol contains these sections, in this order: Title Page, Synopsis, Abbreviations and Definitions, Background and Rationale, Study Objectives and Endpoints, Study Design, Study Population, Eligibility Criteria, Study Treatments, Concomitant Medications, Study Procedures, Schedule of Assessments, Adverse Events and Safety Reporting, Safety Monitoring, Statistical Considerations, Data Management, Ethical Considerations, Regulatory Considerations, Administrative Procedures, Signature Page, References, and Appendices.

Note: If your protocol was created from a protocol template, your organization may have chosen a different set of sections.

Click any section name to open it in the editing area. Each row can also show:

The name of the assigned writer, in small purple text under the section title.
Overdue in red, when the section's authoring due date has passed and it is still empty.
Review overdue in red, when the review due date has passed and the section is not yet approved.

At the right edge of each row is a small status icon:

A green circled check mark — the section is approved.
A blue eye — the section is in review.
An orange circle with an exclamation mark — a reviewer requested changes.
A plain green check mark — the section has content but has not been sent for review.
A small orange dot — a required section that is still empty.
A small gray dot — an optional section that is still empty.
An amber warning triangle — a golden thread alert: a related section changed and this one may need updating. This icon takes priority over all the others.

The buttons along the top#

Above the editing area, from left to right, you will find:

Progress — opens a report of how far along the protocol is. See Progress and audit reports.
Audit Report — a printable record of everything that happened to this protocol. See The audit trail.
Documents — the study documents built from this protocol.
Amendments — appears only after the protocol is approved. See Creating and editing an amendment.
Preview — opens a live PDF preview beside the editor. The button changes to Hide Preview while the preview is open.
PDF, Word, and Redacted PDF — download the protocol as a document. See Downloading PDF and Word documents.
Submit Protocol — a blue button shown while the protocol is a draft. It is gray until every required section has content; rest your mouse on it to see how many required sections are still empty.

The editing area#

What you see in the middle depends on the section:

Most sections are forms: a set of labeled boxes, dropdowns, and lists, grouped into panels you can open and close. See Filling in structured sections.
A few sections (such as References and Appendices) are free text, with a formatting toolbar at the top. See Writing and formatting text.

Every section shows a status badge: Draft (gray), In Review (blue), Changes Requested (orange), or Approved (green). While a section is in review or approved you cannot edit it; a gray bar explains why — for example "This section has been approved. Create an amendment to edit it."

Saving your work#

You almost never need to think about saving. Trelice saves automatically about every 15 seconds while you have unsaved changes. The bottom bar of the editor shows, from left to right: a word count, a History button, and a save status line:

Unsaved changes — you have typed something not yet saved.
Saving… — a save is in progress.
Saved 14:32 — your work is safe, with the time of the last save.

There is also a blue Save button on the right of the bottom bar if you prefer to save by hand.

Troubleshooting: If the status line shows Autosave failed in red, click Retry beside it. If it shows Autosave paused — conflict in amber, click Review to see what happened and choose how to continue.

When two people edit the same section#

If a colleague has the same section open, a blue banner appears: "…is also editing this section. Your save will warn before overwriting their changes." If they save while you are still typing, an amber banner tells you a newer version exists, with a Load latest (discards your changes) link.

If you then save anyway, a dialog titled Someone saved this section first appears. It offers two buttons:

Load latest version — take their version; your unsaved edits are discarded.
Overwrite with my version — keep your edits on top.

Either way, both versions are kept in the revision history — nothing is ever lost.

Recovering unsaved work#

If your session ended or the browser closed with unsaved edits, a blue banner appears the next time you open that section: "You have unsaved changes from …". Click Restore to bring your edits back, or Discard to drop them.

The History panel#

Click History at the bottom of the editor. A count in brackets shows how many saved versions exist.
A panel titled Version History opens on the right, listing every saved version — newest first — with its number, when it was saved, and by whom.
Click a version to see a side-by-side comparison against the current content.
Click Restore this version to put that content back into the editor. It becomes an unsaved edit, so you can still change your mind before saving.

The live PDF preview#

Click Preview in the top bar to split the screen. The right half, headed PDF Preview, shows the finished document page for the section you are editing, and updates as you type. Click Refresh in the preview's header to re-render from the last saved content. An amber panel headed "Editing this section will flag:" lists the related sections a change here would affect — see Golden threads.