Timely and transparent communication with study sponsors is a critical responsibility for all research sites. The DecenTrialz platform is equipped with features that support standardized, audit-ready reporting to sponsors at every phase of participant engagement and study operations,  particularly during the pre-screening and referral process.

This section outlines what information can be shared with sponsors, how to generate reports from the platform, and the ethical and regulatory considerations for site-to-sponsor communication.

What Can Be Reported to Sponsors via DecenTrialz?

Sponsors may require regular updates from sites to track recruitment progress, assess protocol adherence, and ensure overall study performance. The DecenTrialz platform enables sites to report pre-screening-level data that is:

• De-identified (unless explicit participant consent allows otherwise)
• Aggregated or participant-level, depending on sponsor needs and IRB allowances
• Fully aligned with ICH-GCP, HIPAA, and 21 CFR Part 11 requirements

Typical reporting categories include:

Report Type	Details Shared
Prescreening Funnel Metrics	Number of pre-screeners started, completed, disqualified
Referral Activity	Number of participants referred, referral timestamps
Eligibility Trends	Common inclusion/exclusion barriers (non-identifiable)
Participant Disposition	Interested, declined, unreachable, withdrawn (no PHI shared)
Communication Logs	Contact attempt dates, no content of messages shared

Important: Sites must never share identifiable health data or direct participant contact details with sponsors unless:

• Explicit consent has been obtained
• Sharing is IRB-approved
• Required by a regulatory agreement and properly documented

How to Generate Reports for Sponsors

Site admins and delegated coordinators can generate sponsor-ready reports directly from the Reporting Module on DecenTrialz.

To Create a Sponsor Report:

1. Navigate to Dashboard → Reporting → Sponsor Reports
2. Select your trial of interest
3. Choose reporting period (e.g., weekly, monthly, custom)
4. Select metrics to include:
   • Referral stats
   • Pre-screener conversion
   • Communication status
   • IRB document updates (if applicable)
5. Click Generate Report
6. Download in PDF or CSV format, or securely share via sponsor-facing portal link (if activated)

All reports are automatically:

• Timestamped and version-controlled
• Watermarked with trial ID and your site code
• Backed by corresponding audit logs (see Section 5.3.1)

Sponsor Portal Access (Optional)

If enabled by the sponsor and permitted by the site, certain designated sponsor representatives may receive read-only access to a real-time recruitment dashboard.

Sponsor views are:

• Permission-controlled
• Anonymized by default
• Monitored by the platform to prevent data misuse

You may control what metrics are shared and revoke access at any time via the Site Admin Panel.

Regulatory and Ethical Responsibilities

When reporting to sponsors, your site must adhere to the following standards:

• Do not overstate or understate enrollment progress
• Avoid sending reports via unsecured or personal email
• Ensure internal consistency between platform data and your own site SOP logs
• Include IRB reference numbers when submitting updates on approved protocol changes

Sponsors rely on site-reported data to make trial-wide decisions, including budget adjustments, site activation status, and recruitment strategy shifts. Accuracy and ethical rigor are essential.

Key Note: All sponsor reports generated through DecenTrialz are designed to protect participant confidentiality while ensuring full transparency around recruitment and referral activity. When in doubt, always confirm with your site PI or IRB liaison before sharing sensitive or detailed metrics.