Create and structure a protocol

Accessing the Study Designer

The Study Designer is available directly from its dedicated page on this website.

No account is required. Your data is stored locally in your browser (localStorage) — nothing is sent to a server. This also means that if you switch browsers or clear your browsing data, your projects will no longer be available. Remember to regularly export your projects (as JSON, a standard file format) to back them up.

The dashboard

When you open the Study Designer, you land on the dashboard. This is the overview of all your projects.

From the dashboard, you can:

• Create a new protocol by clicking the “New protocol” button
• Import one or more protocols from a previously exported file (useful for recovering a project from another browser, or shared by a colleague)
• Export all your protocols as a single file
• Search through your projects by acronym or title
• Reset all Study Designer data (deletes all projects and restores the default example)

Each project is represented by a card showing its acronym, title, status (draft, submitted, approved, archived), version, and last modified date. The ”…” menu lets you duplicate or delete a project.

Opening a project

Click on a card to open the project. You enter the editor, organized in three areas:

• The sidebar (left): the list of protocol sections. Click a section to navigate to it.
• The header (top): the project name, a toggle to switch between edit mode and read mode, and a link back to the dashboard.
• The content (center): the active section.

By default, a project opens in read mode, which lets you review the protocol without accidentally modifying data. Switch to edit mode to access all fields. When you create a new project, edit mode is enabled automatically.

Let’s go through the first four sections.

General information

The General information section has two tabs: Details and Authors.

Details tab

This tab contains the project metadata:

• Acronym — the short name that identifies your study. It is displayed in the sidebar and on the dashboard.
• Full study title
• Study type — retrospective cohort, prospective cohort, case-control, nested case-control, cross-sectional, randomized controlled trial, or other
• Study objective — descriptive, etiological, prognostic, diagnostic, therapeutic, predictive (machine learning), or other
• Start and end dates — optional, mainly useful for stating the planned duration of the project in a protocol
• Protocol version — optional (default 1.0.0), useful for tracking successive revisions of the protocol
• Status — draft, submitted, approved, archived

Authors tab

This tab lets you list the protocol authors. For each author, you can enter:

• First name and last name
• Role in the study (free text: principal investigator, methodologist, data scientist…)
• Profession (data scientist, clinician, statistician, other)
• Institution
• Email
• ORCID

Authors can be reordered by drag and drop using the handle on the left side of each card.

Context

The Context section contains a single rich text editor. This is where you describe the study background and rationale: state of the art, prior work, research question.

The editor uses Markdown syntax, a simple and widely used formatting language. A few examples: **bold** for bold, *italic* for italic, # Heading for a heading, - item for a list. In read mode, the text is rendered with its formatting. To learn more, see the Markdown guide.

Objectives

The Objectives section has four fields:

1. Primary objective — Markdown editor to describe the study’s primary objective
2. Primary endpoint — Markdown editor to describe the primary endpoint that will measure whether the objective is met
3. Secondary objectives — a dynamic, reorderable list of text items. Click “Add objective” to add one, use drag and drop to reorder.
4. Secondary endpoints — same principle: a dynamic list associated with secondary objectives

Data sources

The Data sources section has two fields:

• Study design — single-center or multi-center
• Data sources description — Markdown editor for a free-form description: clinical database, clinical data warehouse, registry, prior research data, etc.

Key takeaways