Exporting Trial Data

The Exporting Trial Data feature allows Sponsors and Contract Research Organizations (CROs) to securely download pre-screening data associated with a specific clinical trial or set of trials. This functionality is essential for performance analysis, internal reporting, compliance documentation, and integration with external tools such as statistical software, data warehouses, or clinical trial management systems (CTMS).

All exports are governed by strict role-based access controls and follow HIPAA, ICH-GCP, and 21 CFR Part 11 requirements for data protection, traceability, and regulatory readiness.

What Types of Data Can Be Exported

Only data collected during the pre-screening phase may be exported from the DecenTrialz platform. This includes:

1. Participant Funnel Metrics

• Number of matches generated
• Pre-screener completion status
• Eligibility outcomes (Pass / Ineligible / Requires Review)
• Time-to-completion statistics

2. Consent Records

• Timestamped consent logs for referral authorization
• Participant opt-in or opt-out status for future communications
• Record of IRB-approved language shown to the participant

3. Geographic and Demographic Data (De-identified)

• General location data (e.g., state or city)
• Age range, gender, or other demographic filters (if collected and IRB-approved)
• Data visualized by region or site

4. Participant Flags

• Skipped questions
• Inconsistent responses
• Referral readiness status

Note: No protected health information (PHI) or personally identifiable information (PII) will be included unless (a) the export is approved by the Sponsor’s data governance lead and (b) explicitly authorized under the trial’s IRB documentation.

Available Export Formats

Sponsors and CROs may select from the following formats when exporting trial data:

• .CSV – Standard comma-separated spreadsheet format
• .XLSX – Excel-compatible file with preformatted headers
• .PDF – Summary data in printable format, suitable for inclusion in sponsor reports or IRB documentation
• .JSON – Machine-readable data structure for software integrations or API use cases

Steps to Export Data

1. Log in using an account with export permissions (Sponsor Admin or CRO Project Lead).
2. Navigate to the trial dashboard and select “Export Data.”
3. Apply filters as needed (e.g., date range, eligibility outcome, site).
4. Choose export format and whether to include metadata (e.g., site name, timestamps).
5. Authenticate via 2FA and confirm export.
6. A download link will be generated or emailed to the authorized account.

All export activity is logged in the audit trail for regulatory transparency.

Security and Compliance Measures

• Export permissions are tightly role-restricted and monitored.
• All downloads are encrypted in transit and time-limited.
• Every data export is logged, timestamped, and stored in your site’s audit history.
• Any export containing sensitive flags or risk-indicative metadata is reviewed by platform compliance before download is released (where required).

Key Note: Exported trial data provides crucial visibility for sponsors and CROs to evaluate progress, troubleshoot bottlenecks, and maintain regulatory audit readiness. However, data access must be balanced with confidentiality and ethical safeguards. DecenTrialz ensures that all exports adhere to IRB-approved guidelines and participant consent limitations.