Safety Reporting Best Practices
Best practices for safety reporting involve centralizing all safety reporting within one team, using one system for reporting (or a combination of a safety database and a safety reporting portal for investigators), and distributing in accordance with local country rules and regulations.
Safety Reporting Regulatory Intelligence
Lack of clarity in global safety reporting rules burdens teams and leads to over-reporting and compliance risk.
WCG offers an industry “reference model” for global safety reporting for over 125 countries that can be used to eliminate over-reporting, ensure compliance, and dramatically simplify safety reporting decisions.
More and more companies are focused on case processing being performed by qualified health care professionals and avoiding low-cost work, due to the quality and timeliness issues experienced.
Consider putting in place case processing using safety staff or QC staff that can strictly enforce high quality standards and ensure timelines are consistently met, enhancing your drug safety operations and reducing downstream issues on safety reporting.
Investigators & SUSAR Reporting
Investigators are experiencing enormous burden due to industry methods for SUSAR Reporting. An overwhelming array of sponsor processes, portals, unnecessary safety reports requiring acknowledgement and archiving, and sheer SUSAR volume is resulting in some sites simply refusing SUSARs from sponsors – leading to multiple non-compliance.
Industry best practice requires a sponsor to consolidate on one process, one investigator portal for safety reporting, adopt country specific guidelines to minimize over-reporting, and work with sites to eliminate unnecessary steps to receive, process, acknowledge, and file safety reports.
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