This is a placeholder for the FAQ related to the SPEAR online reporting tool.
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.info
Questions are divided into the following subjects:
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GENERAL
The WMDA follows the EU definitions of a serious adverse event or reaction:
Donor, transplant or collection centres are affiliated with donor registries have the possibility to create reports and submit them to the reporting organisation/donor registry. The further handling of the report will go via the donor registry. The donor registry can approve and submit reports from submitting organisations as well as their own incident reports.
When submitted, all reports are available to the WMDA office and the SPEAR Committee. The WMDA office team for SPEAR reporting consists of a medical advisor and a project coordinator. The medical advisor reviews all reported incidents at least once a week and checks for rapid alerts. If necessary, the medical advisor can request the reporting organization for additional information. If the report is approved by the medical advisor, it will be turned over to the SPEAR Committee.
USING THE SPEAR REPORTING TOOL
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.
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
SPEAR REPORTING 101
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.
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 a rapid alert after submitting it by contacting WMDA the by telephone (+31-(0)88 5057900) or e-mail (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.
