Create a research study Open

GoalCopy Anchor Link

Create a research study in Clinical Study Manager: start a draft from Home, complete every setup step (details, contacts, visit workflow, eREG checklist, and Delegation Log), and activate the study.

This guide starts in Clinical Study Manager — that is where sponsor/CRO studies are created.

Before you startCopy Anchor Link

• You need access to Clinical Study Manager for your organization (active license).
• For the Visit Workflow step, a published visit flow must already exist on the license. If you still need to build one (and the eCRFs it attaches), do that first:
  • Create an eCRF form
  • Create a visit flow
• Editing setup requires Update Study data. Creating the draft and activating use separate permissions (called out below).

StepsCopy Anchor Link

1. Create a draft study
   On Research Studies (/), click Create Research Study.
   Permission: Create a Study — without it the button stays disabled.
   Clinical Study Manager creates a draft and opens Create Research Study at /research-studies/[id].
   You can reopen any draft later by clicking its card on Home.

2. Complete Study Details
   Expand Study Details. Fill the required fields (sponsor and study name, subject identifier prefix, protocol fields, study type and phase when applicable, IRB, indication, and related dates), then click Save Details.
   Permission: Update Study data — required for this and every later edit on the draft. Without it, save and edit controls stay disabled.

3. Add Key Contacts
   Expand Key Contacts. Click Add Contact, enter name, email, and role (phone and fax are optional), then confirm Add Contact. Add at least one study key contact.
   Contacts save when you add or remove them (no separate Save on this step).

4. Assign a Visit Workflow
   Expand Visit Workflow.
   If no published visit flows exist yet, use Create visit flow (opens /visit-flow-builder) and follow Create a visit flow. That guide also points to Create an eCRF form when you need published forms to attach to visits.
   When published workflows are available, choose one from the Select workflow list. The assignment saves when you select it.
   This step is incomplete until a published visit flow is assigned.

5. Build the eREG Checklist
   Expand eREG Checklist. Add sections and items that sites will use to file regulatory documents after activation. Click Save.
   The step is complete when the checklist has at least one item.

6. Configure the Delegation Log
   Expand Delegation Log Responsibilities.

   • Add at least one responsibility name, then click Save.
   • Upload the required Delegation Log Cover Page PDF (Upload Cover Page or Replace Cover Page).
     Both the responsibilities list and the Cover Page are required for this step to count as complete.

7. Activate the study
   When the progress sidebar shows all five steps complete, click Activate Study.
   Permission: Activate Study — without it the control stays disabled even if progress is complete.
   There is no separate confirmation dialog. After activation finishes, you are redirected to the study dashboard (/study/[id]). Editing this setup route is no longer available for an active study.

RelatedCopy Anchor Link

• Create Research Study — page overview for the setup route
• Research Studies — create and reopen drafts
• Create an eCRF form — publish eCRFs used by visit flows
• Create a visit flow — publish the visit schedule assigned in step 4
• Visit Flow Builder — builder page overview
• Visit Form Builder — eCRF builder page overview