Create Research Study
Draft research study setup — complete required steps, track progress, and activate the study
URL
/research-studies/[id]— study setup for a draft research study ([id]is the study record id)
Active studies on this route redirect to /study/[id].
Purpose
This page is the setup workspace for a draft research study. Complete the required steps (study details, key contacts, visit workflow, eREG checklist, and Delegation Log), watch progress in the sidebar, and activate the study when everything is ready.
What you can do
- Edit and save study metadata (sponsor, protocol, phase, IRB, indication, and related fields)
- Add and remove study key contacts
- Assign a published visit workflow to the study
- Edit the eREG checklist (sections and items) used by sites after activation
- Define Delegation Log responsibilities and upload the Delegation Log Cover Page
- Jump between setup steps from the progress sidebar
- Activate the study when all steps are complete
Permissions
Page access — Requires a signed-in user with access to Clinical Study Manager and a draft study on the active license. Opening the page is not gated by a study permission; editing and activation are.
| Permission | Purpose |
|---|---|
Update Study data | Allows editing setup steps on a draft study (metadata, contacts, visit workflow, eREG checklist, Delegation Log template and cover page). |
Activate Study | Allows activating the study after every required step is complete. |
Without Update Study data, save and edit controls on a draft stay disabled and show an insufficient-permissions tooltip.
Without Activate Study, Activate Study stays disabled with the same style of tooltip, even when progress shows all steps complete.
Editing is available only while the study status is draft. After activation, this route redirects to the study dashboard.
On this page
Header
Title Create Research Study with a short description of the setup form.
Setup steps
A scrollable column of collapsible (or always-visible) setup blocks:
- Study Details — Protocol information, sponsor details, and study parameters; Save Details persists changes.
- Key Contacts — Study key contacts for the research study; add and remove while the study is draft.
- Visit Workflow — Select the published visit schedule template for this study.
- eREG Checklist — Define the table of contents sites use to file eREG documents after activation.
- Delegation Log Responsibilities — Define the responsibilities legend for site Delegation Logs, and upload or replace the required Delegation Log Cover Page.
Incomplete steps can be expanded from the progress rail; some steps open expanded when they are the next incomplete item.
Progress sidebar
Shows overall percent complete, how many of the five steps are done, and a step rail that scrolls to each section. Activate Study sits at the bottom and stays disabled until every step is complete (and you have Activate Study).
Related guides
- Create a research study — create a draft, complete setup, and activate
- Create a visit flow — publish the visit schedule assigned on this page
- Create an eCRF form — publish eCRFs used by visit flows