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Since April 4th 2022 the new SPEAR 2.0 reporting tool is in use. This tool will continue to receive updates and therefore the content of this user guide is subject to change along with the updates that are implemented. Please check back regularly if you are encountering issues you've not encountered before and bare with us while we work on optimizing the SPEAR reporting process. |
Introduction
The WMDA believes that donor health and safety are of critical importance to ensure the continued viability of the global infrastructure of volunteer donors andtherefore requires its members to report and investigate Serious (Product) Events and Adverse Reactions (S(P)EARs). The WMDA has been collecting data on serious events and reactions since 2003. In this document, you can read more on SPEAR reporting and on how to use the SPEAR online reporting tool. Answers to the most common issues and questions will be provided, but i you encounter any technical difficulties in using the system and cannot resolve them by reference to this user guide, please contact the WMDA office at sear-spear@wmda.info. The SPEAR online reporting tool can be accessed here
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Content
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Note | ||
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Since April 4th 2022 the new SPEAR 2.0 reporting tool is in use. This tool will continue to receive updates and therefore the content of this user guide is subject to change along with the updates that are implemented. Please check back regularly if you are encountering issues you've not encountered before and bare with us while we work on optimizing the SPEAR reporting process. |
Other useful documentation and external links
- Access the SPEAR online reporting tool
- Examples of SEAR/SPEAR reports
- WMDA Imputability Assessment Tool
- Educational webinar on SPEAR reporting (March 2020)
- Operating of the SPEAR Committee
- Standard Operating Procedure for reporting SEAR/SPEAR
- Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- International Statistical Classification of Diseases and Related Health Problems 10th Revision
- Notify Library
Important information
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Content
This user guide provides you with instructions on how to use the SPEAR online reporting tool. It is designed to assist you with using the features of the SPEAR reporting tool to submit SPEAR data to the WMDA in the easiest way possible.
Other useful documentation and external links
- Access the SPEAR online reporting tool
- Examples of SEAR/SPEAR reports
- WMDA Imputability Assessment Tool
- Educational webinar on SPEAR reporting (March 2020)
- Operating of the SPEAR Committee
- Standard Operating Procedure for reporting SEAR/SPEAR
- Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- International Statistical Classification of Diseases and Related Health Problems 10th Revision
- Notify Library
List of content
Table of Contents |
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