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Serious (Product) Events and Adverse Reactions: S(P)EAR
The WMDA has set up a central global reporting system for WMDA member organisations to report Serious (Product) Events and Adverse Reactions – S(P)EARs – to the WMDA.
Aim
- To gain insight in the occurrence of serious events and adverse effects in relation to blood stem cell donation by unrelated donors and blood stem cell collection/processing from unrelated donors.
Purpose
To collect and analyze information on recipient and donor serious adverse events (SAE) and reactions which affect donors and/or products from all WMDA stem cell
donor registries and cord blood banks.To follow a rapid alert system for disseminating information on SAE/R to all members of the international community in contact with allogeneic donors and patients.
Quick links
- Submit a SEAR/SPEAR incident
- Examples of SEAR/SPEAR reports
- Common Terminology Criteria for Adverse Events v3.0
- International Statistical Classification of Diseases (ICD) 10th revision
- Notify Library
- Imputability Assessment Tool
- Operating of the S(P)EAR Committee
- Standard Operating Procedure for reporting SEAR/SPEAR
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S(P)EAR reports
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