Assigning research sites to a clinical trial is a foundational step in operationalizing a study within the DecenTrialz platform. This process ensures that authorized research sites can begin pre-screening participants, view eligibility requirements, and maintain protocol-aligned communication, all within a HIPAA- and ICH-GCP-compliant environment.

This section provides Sponsors and CROs with step-by-step guidance on how to assign, manage, and monitor research site access for a given trial.

Who Can Assign Sites

Only the following roles have the authority to assign sites to a trial on DecenTrialz:

• Sponsor Administrators
  (Full access to all trials funded by their organization)
• CRO Administrators
  (Granted permission by the associated Sponsor account)
• Designated Project Managers
  (Optional role, if delegated by the Sponsor or CRO with limited permissions)

Site assignment privileges are restricted to prevent unauthorized access or unapproved trial activity.

Steps to Assign a Site to a Trial

1. Navigate to the Trial Management Console

• Select the trial for which you want to assign research sites.
• Ensure the trial status is in “Draft” or “Pending Activation”.

2. Select “Assign Site(s)” Option

• You may choose from:
  • Pre-registered research sites already onboarded and approved
  • New sites by initiating an invitation workflow (subject to platform approval)

3. Define Access Parameters for Each Site

For each site assigned, configure:

• Site-specific contact (PI or Site Coordinator)
• Geographic region (auto-filled based on address)
• Participant cap (if applicable)
• Trial phase access (e.g., pre-screening only or full protocol access)

4. Confirm Assignment and Send Notification

• Once configured, click “Assign Site”.
• The designated site admin will receive an invitation with credentials and instructions to begin pre-screening.

Managing Multiple Sites

The platform supports:

• Bulk assignment for multi-site studies
• Site-specific eligibility overrides (only if authorized by protocol)
• Site performance monitoring dashboards after assignment
• Easy revocation or pause of site access if needed

Changes in site status (e.g., paused, removed) are logged and timestamped in the audit trail.

Site Assignment FAQs

Can I assign a site to multiple trials?

Yes. A site with a verified account may be assigned to multiple active trials if eligibility and geographic relevance are satisfied.

Can a site self-assign to a Sponsor’s trial?

No. Sites may only be assigned through an authorized Sponsor or CRO user with appropriate trial access rights.

Can I assign a site that hasn’t registered yet?

Yes. The system allows Sponsors to initiate a Site Invite Link, which prompts the site to register and upload required credentials before final activation.

Key Oversight Responsibilities

Sponsors and CROs assigning sites must:

• Ensure that all IRB documentation is on file at the time of site activation
• Confirm site credentials and license validity before assignment
• Monitor adherence to trial-specific communication and reporting protocols
• Periodically review site activity to ensure compliance and data integrity

Key Note: Site assignment is not just an operational step, it is a regulatory responsibility. Proper assignment ensures data traceability, participant protection, and trial quality. DecenTrialz provides tools for controlled, transparent, and auditable site engagement to uphold both ethical and regulatory standards.