This blog focuses on quality specific and provides insights on how to improve case intake in pharmacovigilance, highlighting some recommended best practices.
Case intake: The process
Case intake is the process to receipt the case based on source documents, meanwhile the cases can be received to central by several ways such as Emails or fax and in also in several formats commonly XML, not only limited to electronic format.
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The below practices are, If you are in a dedicated team solely responsible for case intake and monitoring:
Best practices to follow
- At least two mandatory checks for case receipt in every business day.
- Confirm the completeness of all the necessary details received related to cases.
- Download and save all necessary information related to cases, For example sources and any mail communications.
- Identify and Filter the cases based on priority, seriousness and significance.
- Determine the case type (Solicited, Unsolicited & Pre-marketing, post-marketing).
- Seek for additional Medical advice, if necessary.
- Do request for professional translation, if necessary.
- To promptly inform and forward cases to designated team ASAP to initiate book-in process in a timely manner.
- Documentation and Archiving: Ensure proper documentation, archiving, and traceability of case intake activities to support audits, regulatory inspections, and future reference.
- Repeat the process.
All the points mentioned above are based on our best practices, which have proven effective in helping us achieve our goals.
While some of these practices may seem simple or straightforward, they have consistently yielded positive results.
We encourage you to apply these logical standards and kindly leave us a comment below to share your experience the next time you visit.
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For beginners seeking to enhance their processes with high-quality standards, feel free to download our ICSR Quality Checklist. It’s designed to support your journey and elevate your approach. Get your copy now!
Conclusion
While this advice may seem standard and something everyone does, ensuring its consistent implementation within the team is questionable. Therefore, it needs to be included in training to ensure adherence by the team.
Feel free to mention if you and your team follow additional practices, as they would be highly appreciated.
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