Argus E2B File Transfer Disclaimer – Oracle Argus Safety

This secure file transfer service is operated by Cencora and is provided for the purpose of uploading and downloading Individual Case Safety Report (ICSR) files and approved supporting pharmacovigilance documentation associated with a customer’s designated Oracle Argus Safety environment.

Permitted Use

• This service may be used solely for the secure upload and download of ICSRs and related pharmacovigilance data intended for processing within Oracle Argus Safety.
• All file transfers must relate to the correct customer, product, and Argus environment as agreed with Cencora.
• Downloaded files must be handled in accordance with applicable confidentiality, data‑protection, and regulatory obligations.

Other File Types

• File types other than ICSRs or standard supporting pharmacovigilance documents must not be uploaded or downloaded unless explicit prior approval has been granted by the Cencora Argus team.
• Any approved exceptions will be limited in scope and governed by agreed operational and security controls.

Data Responsibility

• The submitting organisation remains responsible for the accuracy, completeness, integrity, timeliness, and regulatory compliance of all data transferred using this service.
• All ICSRs must comply with applicable regulatory requirements, including ICH E2B standards, and with agreed submission formats and naming conventions.

Security, Monitoring, and Audit

• File transfer activity may be logged, monitored, and retained by Cencora in line with contractual agreements, regulatory expectations, and audit requirements.
• This service does not replace formal regulatory submission channels or statutory reporting obligations.

If files are uploaded or downloaded in error, or if clarification is required regarding permitted file types or usage, please contact your designated Cencora Argus support contact immediately.