Who is responsible for post-closeout study data?
Per regulatory guidelines, it is the Sponsors’ responsibility that: “Any system where investigators enter data should be providing this data at the conclusion of a Clinical Trial”. However, when your study is closed and archived, the investigators are no longer able to access cumulative IRT data. Should a site be audited, it would not have sufficient cumulative IRT data to accurately recreate the full traceability and history of subject and kit data.
IXRS®3 Archival Site Data – Investigator Access
Archival Site Data Investigator Access tool allows investigators and other designated personnel to download unblinded trial data for their site via data export at study closeout.
Sites will be prompted via email notification when the study has been enabled to allow end of study downloads. Sites will also receive follow up reminders if they have not performed this task. Study reports will be available to provide visibility of each site completing this step to allow monitoring and ensure site compliance.
IXRS®3 Archival Site Data – Investigator Access
Download Fact Sheet
Providing investigators with cumulative IRT data at the end of a study is challenging.
Using the IRT directly is the best true way to ensure all the investigator owned IRT data is provided. Otherwise, you may be relying on external systems containing partial data or taking on the manual task of parsing and distributing data yourself. This IXRS®3 tool automates the process of providing the necessary comprehensive data directly to sites at the right time.
Adherence to current regulations becomes much easier with the ability to provide necessary access to site data with one click. Now, you can enable investigators and other personnel to download unblinded trial data exports for a limited time during study closeout and receive prompt reminders to do so.
Compliance and audit-readiness
Your trial data is maintained per regulatory guidelines
One-click enablement
Once the time is right, effortlessly launch access for each site
Safety and control
See which sites have completed the data export
Peace of mind
Prepare for smooth study closeout from the start
Add these products and services to your IRT build to increase its efficiency, compliance, and transparency.
ART™
Reconciliation Tracking
Reconciliation Tracking
OVERSIGHT
Trial Data Integrity
Monitoring System
Trial Data Integrity
Monitoring System