Golden threads: keeping sections consistent

Why a warning appears when related sections disagree, and how to clear it.

Also known as cross-section consistency checking.

A protocol says the same important things in several places. The sample size appears in the Synopsis, the Study Design, and the Statistical Considerations. If an amendment changes it in one place and not the others, reviewers — and regulators — will notice. In Trelice these shared facts are called golden threads, and the system keeps watch over them for you.

There are five threads, each covering one family of facts:

• Objectives, Endpoints & Statistical Analysis — the study's objectives and endpoints, and the statistics that analyze them.
• Inclusion / Exclusion Criteria — who may and may not join the study.
• Schedule of Assessments — the visits, the assessments, the design type, and the study duration.
• Dosing & Interventions — the study drug, its dose and duration, and the study's identifying details.
• Sample Size Assumptions — how many subjects, how many sites, and the numbers behind the calculation.

The Threaded badge#

In a form section, a shared field carries a small amber chip labeled Threaded, with a tiny lightning bolt, beside its label.

1. Click the Threaded chip.
2. A popover opens naming the shared value (for example "Total Sample Size") and explaining "Linked in 3 sections — editing any one updates all".
3. Click one of the listed sections to jump straight to the matching field there. The target briefly glows with an amber ring so you can spot it.

Because linked fields are true copies of one another, you can edit whichever one you are in. When you save, Trelice carries the new value to all its peers — you never retype it.

When the warning appears#

Some connections are looser than a straight copy — for example, the Statistical Considerations discuss the primary endpoint rather than repeating it word for word. When someone saves a change to a thread's source material, Trelice cannot rewrite your prose for you. Instead it flags every related section for a human check.

What you'll see:

• In the section list on the left, the flagged section shows an amber warning triangle instead of its usual status icon.
• Inside the section, an amber banner appears headed Golden Thread Alert — followed by the thread's name. The message reads, for example, "Statistical Considerations was updated. Verify that this section still aligns with the "Sample Size Assumptions" golden thread." Below it, the banner may list the changed values, and shows when the alert was raised.

The banner also tells you what to do: "Update this section to reflect the change, then save — saving will clear this alert. Reviewers must acknowledge this alert before approving."

To clear an alert:

1. Read the banner to learn which section changed and what the new values are.
2. Update your section's wording so it agrees.
3. Save. The banner and the amber triangle disappear.

If your section already agrees, a save with no changes still clears the alert — the point is that a person looked.

Note: with the live PDF preview open, an amber panel headed "Editing this section will flag:" lists the sections your current edits would put on alert — useful before you commit to a change. See the editor overview.

Editing a value shared with an approved section#

If you change a threaded field whose value also lives in an already-approved section, that approval can no longer stand. Trelice will not do this silently:

1. When you save, a dialog appears titled Confirm: re-open approved section (or "sections").
2. It lists each affected section, the shared field, and its writer, and warns that saving will move those sections back to DRAFT and notify their writers. Re-review will be required.
3. Click Save and reopen to proceed, or Cancel to keep everything as it was.

Note: automatic saving never makes this decision for you. If an autosave runs into this situation, it simply pauses and the save status line shows Autosave paused — conflict with a Review link — the choice is always yours.

Reviewers must acknowledge alerts#

An alert is not just advice — it blocks approval until a reviewer confirms the check was done.

• In the editor, a reviewer whose turn it is sees a checkbox beside the approve button: I've verified cross-section consistency. The Approve button stays gray until it is ticked.
• In your approval queue, flagged sections show the same amber alert block with a checkbox reading I have verified cross-section consistency for this golden thread.

This acknowledgment is recorded, so the audit trail shows that consistency was checked by name and date. For the reviewer's side of the process, see Reviewing and approving.

Troubleshooting: if Approve is gray and you cannot tick anything, look above the editor for the amber banner — the checkbox appears only while an unacknowledged alert exists, and only for the reviewer whose turn it is.