Reporting and Submissions in Argus Safety

Reporting and submissions in Argus Safety are essential components of pharmacovigilance, and Oracle Argus Safety provides robust functionalities to generate regulatory reports and submit them to health authorities. Here’s an overview of reporting and submissions in Argus Safety:

1. Regulatory Reporting: Argus Safety enables users to generate regulatory reports, such as individual case safety reports (ICSRs), periodic safety update reports (PSURs), and signal detection reports, as well as ad-hoc reports for internal management purposes.
2. Submission Management: Argus Safety provides a centralized platform to manage regulatory submissions, including tracking the status of submissions, scheduling submission deadlines, and monitoring the submission history.
3. Electronic Submissions: Argus Safety supports electronic submissions to health authorities, including E2B(R3) and ICH M2 formats, as well as other custom formats required by specific regulatory agencies.
4. Compliance Management: Argus Safety includes built-in compliance features, such as validation rules and submission checklists, to ensure that regulatory reports comply with the required formats and guidelines.
5. Submission Tracking: Argus Safety tracks the submission history of each case, enabling users to monitor the status of each submission, including acknowledgment receipt, validation errors, and rejection reasons.
6. Communication Management: Argus Safety includes built-in communication features to manage interactions with health authorities, including submitting follow-up information, responding to queries, and managing commitments.

Overall, the reporting and submissions functionalities in Argus Safety are designed to support efficient and accurate adverse event case management, helping pharmaceutical companies comply with regulatory requirements and ensure patient safety.

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