Protocol templates

Build reusable protocol outlines so every new protocol starts the way your organization likes.

A template is a reusable outline for a protocol. It decides which sections a new protocol starts with, in what order, who should write each one, and who must review it. Build a template once, and every new protocol in your organization can start the way you like — instead of the standard set of 21 sections.

This guide is for administrators. To open the page, click Templates in the Administration group of the left-hand menu. You will see a page titled Protocol Templates, described as "Reusable structures with section definitions and role assignments".

The page at a glance#

Each existing template appears as a card showing its name, description, how many sections it contains, and — if golden threads are enabled — a small note such as "5 threads active". Each card has an Edit button and a red Remove button. Below the title, the card lists every section; an orange dot marks required sections, a gray dot optional ones.

If you have no templates yet, the page says "No templates yet. Create one to speed up protocol development." That is fine — protocols can always be created without one.

Creating a template#

1. Click the New Template button in the top-right corner.
2. What you'll see: a window titled New Protocol Template.
3. Type a name in the Template Name box — for example "Phase 1 Oncology Standard".
4. Optionally, add a Description so colleagues know when to use it.

Choosing the sections#

The Sections area starts with one section row. Each row has, from left to right:

• A dropdown listing the standard section types — Title Page, Synopsis, Objectives & Endpoints, Study Design, and so on.
• A box labeled "Custom title (optional)". Leave it as is to use the standard name, or type your own — for example "Background" instead of "Background & Rationale".
• A Required checkbox. Required sections must be completed before the protocol is considered finished.

To build the outline:

1. Click Add Section to add another row.
2. Pick the section type in the dropdown.
3. Use the small up and down arrows at the right of each row to change the order. The order here is the order writers will see in the editor.
4. To delete a row, click the small red trash symbol.

Writers, reviewers, and instructions#

Click More on a section row to open its detail panel. It closes again with Less. The panel holds three settings:

• Writer Role — restrict who may write this section. The default, — Any —, lets any writer work on it. Choosing, say, Biostatistician means the Statistical Considerations section belongs to your statisticians.
• Required Reviewer Roles — the roles that must review this section before it can be approved. Click + Add role and pick from the list; each choice appears as a small blue tag (click its × to remove it). If you add none, the panel says "None — any user may review". These become the section's required reviewer roles in every protocol made from the template — see Sending a section for review.
• Instructions for writer — a free-text note shown to the author, such as "Include the dose-escalation rationale here."

Note: Required reviewer roles on a template work alongside your organization's review workflows. The template says which roles must sign off on a section; a workflow says in what order levels of reviewers take their turn.

Golden threads#

Below the sections is the Golden Threads area. The page explains: "Golden threads automatically flag dependent sections when a source field changes. Disable threads that are not applicable for this protocol type."

Each of the five threads — Objectives, Endpoints & Statistical Analysis, Inclusion / Exclusion Criteria, Schedule of Assessments, Dosing & Interventions, and Sample Size Assumptions — has an on/off switch and a small diagram of the fields it connects. All five start on. Turn one off only if it truly does not apply; for example, a study with a single fixed dose may not need the dosing thread. See Golden threads: keeping sections consistent for how the warnings work.

Saving#

1. Click Create Template at the bottom. (When editing, the button reads Update Template.)
2. What you'll see: the window closes and your template appears in the list.

How a template is used#

When someone creates a protocol inside a study, the New Protocol window shows a Start from Template choice (it only appears once at least one template exists):

• Blank protocol (all ICH E6 sections) — the standard 21-section scaffold.
• Each of your templates, with its section count.

Choosing a template seeds the new protocol with exactly the template's sections, titles, order, required flags, writer restrictions, reviewer roles, and enabled golden threads. See Working with studies for the full protocol-creation steps.

Note: Changing a template later does not change protocols already created from it. A template is a starting point, not a live link.

Removing a template#

1. Click the red Remove button on the template's card.
2. A confirmation asks "Deactivate this template?". Click OK.

Removing a template only stops it being offered for new protocols. Protocols already created from it are untouched.

Troubleshooting: If Create Template does nothing, look for a red message in the window. A template needs a name and at least one section.