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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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USING THE SPEAR REPORTING TOOL
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| title | How can I get access to the WDMA SPEAR online reporting tooldo I register as a SPEAR reporter? |
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To become a SPEAR reporter, you contact the WMDA office by e-mail: sear-spear@wmda.info In this email please provide us with the following information: - First and last name of the SPEAR reporter
- Name of the organization the reporter will submit SPEARs for
- Type of organization:
- DR = Donor registry
- CBB = Cord blood bank
- DRCBB = Donor registry with CBU
- TC = Transplant centre
- DC = Donor Centre
- If applicable: if there's an affiliated parent organization, please provide the name of this organization. Please note that a parent organization can request access for their affiliated centres too.
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| title | I forgot my username/password. What should I do? |
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When you go to the SPEAR reporting tool login page you will find the login module where you can enter your email address and password. Click on “forgot password?” button underneath the Password field. Enter your email address in the designated field and press the “Submit” button. You will then receive a link to reset your password. If you haven't received the email with a reset link for your password within 24 hours (please check your spam folder too), please contact the WMDA office at sear-spear@wmda.info |
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| title | What new features are available in the 2022 rebuild of SPEAR? |
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SPEAR REPORTING 101
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| title | What to report and what not to report? |
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WMDA member organisations and their affiliated organisations are obliged to report to WMDA any unexpected donor and/or patient issue or product quality issue in a timely manner. If necessary, urgent measures can then be implemented to protect donors and/or patients, such as a recall of one or more defective batch(es) from the market or change in policies and procedures. Any adverse event or reaction, or risk thereof, that occurs during any step in the stem cell donation process can and should be reported in the SPEAR online reporting tool. This includes adverse events or reactions that occur to patients and donors, related and unrelated. |
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| title | How do I assess the imputability? |
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The WMDA has developed an imputability assessment tool to help you determine the imputability grading most fitting with your adverse reaction report. |
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| title | What ICD-10 refence can I use? |
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Please make sure you use the correct ICD-10 code when prompted. You can refer to the ICD-10 database here. This will help us when we use the SPEAR data for short- or long-term analysis and to gain insight into possible trends. |
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| title | Is this mobilising agent a Filgrastim, Lenograstim or other? |
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Please see page 15 in this publication by IQVIA for a summary of EMA information for approved indications for G-CSF products |
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| title | Reporting a Rapid Alert |
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In case of recall or big risks for future donations or transfusions a report can be submitted as a rapid alert. This includes, but is not limited to: - any prohibition or restriction imposed by the competent authority/health authorities of any country in which the stem cell product is provided or transplanted;
- donor death;
Please flag your report as If you have a rapid alert after submitting it by contacting WMDA the case to report, please submit it via the online reporting tool and contact the WMDA immediately by telephone (+31-(0)88 5057900) or e-mail (at sear-spear@wmda.info). If the report qualifies as a rapid alert and for dissemination to the international community, it will always be shared without any traceable information on the reporting agency, donor, patient or reporter. In addition, reporters should notify their competent authorities/health where incident has occurred. |
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