Study Design (Protocol Design)

This guide walks you through the process of creating and configuring a clinical study in the Clinical Trial Management System (CTMS).

Target Audience

Role	Access Level
Study Designer	Full access to create and configure studies

note

Only users with the Study Designer role can create and publish studies.

Workflow Overview

The study design process follows these steps:

1. Create Study — Fill in study overview details
2. Set Eligibility — Define inclusion/exclusion criteria
3. Assign Sites — Link trial sites to the study
4. Assign Personnel — Add Study Coordinators and Principal Investigators
5. Assign Subjects — Enroll participants and link to coordinators
6. Assign eCRFs — Attach Case Report Forms for data collection

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Step 1: Create Study

1. Navigate to Studies from the sidebar menu
2. Click New Study button
3. Fill in the study overview details:
   • Study Name
   • Study Type (Interventional/Observational)
   • Study Phase
   • Expected Start/End Dates
   • Expected Number of Participants
   • Description

4. Click Save to create the study

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Step 2: Set Eligibility

Define the inclusion and exclusion criteria for participant enrollment.

1. Open the study and go to the Eligibility tab
2. Add eligibility criteria as needed

info

This section is currently a placeholder for future eligibility configuration.

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Step 3: Assign Sites

Link clinical trial sites where the study will be conducted.

1. Navigate to the Sites tab
2. Click Add Site
3. Search and select sites from the available list
4. Configure site-specific settings
5. Click Save

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Step 4: Assign Study Personnel

Add team members who will manage the study at each site.

1. Navigate to the Study Personnel tab
2. Click Add Personnel
3. Search for users with the following roles:
   • Study Coordinator — Manages day-to-day operations
   • Principal Investigator — Leads the study at the site
4. Select personnel and click Add

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Step 5: Assign Subjects

Enroll participants (subjects) into the study.

1. Navigate to the Subjects tab
2. Click Add Subject
3. Search for patients from the patient registry
4. Assign each subject to a Study Coordinator
5. Click Save

tip

Subjects are linked to Study Coordinators for streamlined data collection and monitoring.

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Step 6: Assign eCRFs

Attach the electronic Case Report Forms used for data capture.

Prerequisite

Ensure the required eCRF forms have been created before this step. See Creating e-CRFs for instructions.

1. Navigate to the CRFs tab
2. Click Add CRF
3. Select from available CRF templates
4. Click Add to link the CRF to the study

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After Publishing

Once the study is published:

• Study Coordinators begin data collection
• Subjects complete visits and eCRF data is captured
• The study continues until the expected end date or completion

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Quick Reference

Step	Tab	Action
1	Overview	Create study with basic details
2	Eligibility	Define participant criteria
3	Sites	Link trial sites
4	Study Personnel	Add coordinators and investigators
5	Subjects	Enroll participants
6	CRFs	Attach data collection forms