eREG Checklist
Study eREG checklist — edit the table of contents on drafts, or review a site’s certified eREG document uploads after activation
URL
/study/[id]/ereg-checklist— eREG checklist for a research study ([id]is the study record id)/study/[id]/ereg-checklist?siteId=[siteId]— same page scoped to one organization study site ([siteId]is the site record id)
Open this route from the study sidebar (eREG Checklist) or from Site Overview via View eREG uploads.
Purpose
This page is the study eREG checklist in Clinical Study Manager. On a draft study it is where you edit the table of contents of eREG checklist sections and items. After activation it is read-only for the catalog: pick a site and inspect that site’s certified eREG document uploads and version history (no certify or upload from this app).
What you can do
Draft study
- Review and edit eREG checklist sections and items (rename, reorder, add or remove items, remove sections)
- Save checklist changes when you have permission
Activated study (active, paused, or closed)
- Choose which organization study site to inspect
- Browse checklist sections and items for the selected site
- See whether each item is incomplete or has a current certified file (with version)
- Download the current certified file when a link is available
- Open History for items that have prior versions
If the study has no sites yet, the page explains that you need to invite a site before you can review uploads.
Permissions
Page access — Requires a signed-in user with access to Clinical Study Manager and a research study on the active license. Opening the page and viewing a site binder are not gated by a dedicated eREG permission; editing the draft checklist is.
| Permission | Purpose |
|---|---|
Update Study data | Allows editing and saving the eREG checklist while the study is a draft. |
Without Update Study data, save and edit controls on a draft stay disabled and show an insufficient-permissions tooltip.
After activation the checklist catalog is immutable. This page does not upload or certify site documents — that happens in CSM Site Portal. Sponsor review here is read-only for current files and history.
On this page
Header
Title eREG Checklist. On a draft, the description explains the study table of contents. After activation, it describes certified uploads for the selected site, and a site selector appears in the header filters.
Site selector
Shown only when the study is not a draft. Lists enrolled sites as {name} ({Site ID}). Changing the selection updates the siteId query parameter. While sites load, or when there are none, the control is disabled.
Draft checklist editor
When the study is a draft, the main area is the editable checklist: sections with items, drag-and-drop reorder when editing is allowed, and Save at the bottom. Primary setup for adding sections also appears on Create Research Study.
Site binder
When the study is not a draft and at least one site exists, the main area lists eREG checklist sections for the selected site. Each item shows Incomplete, or the current file name with Version Number, plus History when prior versions exist.
No sites yet
When the study is not a draft and has no sites, an empty state asks you to invite a site to review eREG uploads and history. Use Sites to invite sites.
Related guides
- Create a research study — includes building the eREG checklist before activation