The DecenTrialz platform is designed to support both single-site and multi-site clinical trials. Sponsors and CROs managing multi-center studies can upload trials centrally while assigning relevant roles and permissions to each participating research site. This functionality ensures consistency across study protocols, eligibility criteria, and compliance standards, while allowing site-level operational flexibility.

This section explains the process, permissions, and best practices for uploading and configuring multi-site clinical trials on the platform.

Who Can Upload Multi-Site Trials

The following user roles may initiate and manage the upload of a multi-site trial:

• Sponsor Administrator (Primary responsibility for initiating trials)
• CRO Administrator (If granted trial setup privileges by the Sponsor)
• Authorized Delegates (e.g., project leads or data managers with restricted access)

All trial uploads are logged in the digital audit trail and may be reviewed for compliance purposes.

Steps to Upload a Multi-Site Trial

Step 1: Navigate to “Trial Management”

• Access the Sponsor Dashboard or CRO Dashboard
• Click on “Add New Trial”
• Choose the “Multi-Site Trial” option

Step 2: Complete Trial Overview Form

Provide core trial metadata including:

• Study Title and Protocol Number
• Therapeutic Area and Indication
• Phase of Study (I, II, III, IV, or observational)
• Study Start and Expected Completion Dates
• Primary and Secondary Objectives
• Sponsor and CRO (if applicable)

This ensures standardization across all participating sites.

Step 3: Upload Required Study Documents

Attach the following:

• Finalized protocol (PDF)
• IRB approval letter (if centralized)
• Investigator Brochure (optional)
• Site training materials (if available)

Each document will be available only to the assigned sites and DecenTrialz admins for quality assurance.

Step 4: Assign Sites to the Trial

Refer to the Assigning Sites section. You must assign at least one approved site for the trial to move to “Live” status.

Step 5: Configure Participant Pre-Screening Rules

• Define global eligibility criteria to apply across all sites
• Set custom parameters if some sites have local inclusion/exclusion modifications (optional and subject to sponsor sign-off)
• Select whether participant matching should be handled centrally or by site coordinators

Step 6: Save as Draft or Submit for Activation

• Trials can remain in Draft status for internal review
• Once finalized, mark as “Ready for Review”
• DecenTrialz Support team will conduct a quality control check before moving the trial to Live

Best Practices for Multi-Site Uploads

• Centralize documentation: Ensure all shared materials (protocols, consents, training guides) are consistent across sites.
• Maintain traceability: Use the audit trail to track all document uploads, modifications, and site assignments.
• Enable version control: When updating study materials, clearly label version numbers and dates to avoid confusion at the site level.
• Clarify sponsor-CRO roles: Clearly define who is responsible for document updates, site communication, and compliance tracking.

Post-Upload Trial Statuses

• Draft – Not visible to sites, still under internal setup
• Pending Review – Submitted for DecenTrialz quality review
• Live – Trial is active and pre-screening can begin
• Paused – Trial activity temporarily halted (e.g., protocol amendment in progress)
• Closed – No longer accepting participants

All status changes are logged and timestamped.

Key Note: Uploading a multi-site trial through DecenTrialz simplifies operational complexity while maintaining regulatory oversight. By centralizing study setup and standardizing access controls, Sponsors and CROs can ensure that every site runs from the same validated foundation, minimizing risks, reducing errors, and accelerating enrollment readiness.