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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 collects and analyses information on recipient and donor S(P)EARs togain insight in the occurrence of serious events and adverse effects in relation to cell donation, collection and processing. Trends and patterns can be identified and if necessary, rapid communication on severe incidents can be disseminated to the global community. The WMDA has been collecting data on serious events and reactions since 2003. In the early years, data was submitted on paper to the WMDA. Later on this evolved to a simpleonline survey form.Bothmethods left little opportunity for thorough data analysis. Therefore, since 2019, a online reporting tool is in use for SPEAR reporting. In 2022, this tool received a major update. Below, you can read more on SPEAR reporting and on the latest SPEAR online reporting tool. If you have any questions, please reach out to the WMDA office at sear-spear@wmda.infothis 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
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.
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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
- The SPEAR reporting tool is a web-based application, thus it may be subject to delays depending on the speed of the internet connection and server load. If you are not able to access the login screen of the application, please check that your internet connection is in proper working order.
- The SPEAR reporting tool is secured using HTTPS. Because of this all communications between the web browser and server are encrypted, guaranteeing data privacy and security.
- The SPEAR reporting tool is accessible at all times unless it is unavailable as part of any upgrades or maintenance work.
- The SPEAR reporting tool is only available in the English language.
- Next to some questions you can find an
icon with more explanation on what type of answer is requested.
Questions are divided into the following subjects:
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GENERAL
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The WMDA follows the EU definitions of a serious adverse event or reaction:
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