SEAR and SPEAR

The Serious (Product) Events and Adverse Reactions of WMDA or "SEAR" and SPEAR" are a central reporting system of the WMDA member organizations to the WMDA S(P)EAR Committee. SEAR's goal is to obtain insight in the occurrence of serious events and adverse effects in relation to stem cell donation by unrelated donors while SPEAR's goal is to obtain insight into the occurence of serious events and adverse effects in relation to stem cell harvest and processing from unrelated donors.

All participating member organizations receive a reminder by e-mail quaterly. Participating is compulsory for WMDA accredited registries.
To relate the total number of serious events to the total harvests of each type from participating registries, relevant general information will be extracted from the annual report and reported as total accumulated data of the donor registries.

The chair of the Clinical Working Group annually reports the number of reported incidents. The Annual Report of the WMDA also contains lists of participating registries and detailed information about the number of incidents.

Below these links to the online reporting system, the forms and the manuals, you will find more information about SEAR and SPEAR.

• SEAR Standard Operating Procedure (SOP)
• S(P)EAR Examples of what to report and what not to report
• Common Terminology Criteria for Adverse Events v3.0
• International Statistical Classification of Diseases (ICD) 10th revision
• Download here the entire S(P)EAR online questionnaire in PDF (v2013)
• Download here the entire S(P)EAR online questionnaire in an editable wordfile (v2013)

• Link to the Online Survey System

Changes Online S(P)EAR Survey 2013:

• On page one you can fill multiple email addresses. Only the first address is required, the other are optional. Please bear in mind that every email address you enter will receive a copy of the report.
• The follow-up procedure has been slightly altered: On the very last page is a question where you can fill the date when you want to follow-up the report. On that day the WMDA Office will send you a link to edit the original report online. When you're done editing you can resubmit the report and a new PDF will be generated and emailed. The WMDA Office keeps a copy of every version of every report.
• A new question in the SPEAR area has been added which asks what happened if the product was not used.
• Also on the SPEAR page the definition of inadequate cell dose has been removed. The survey taker can decide for him/herself if the cell dose was adequate or not.

Tips & Tricks for the Online Reporting System:

• Make sure your browser has enabled JavaScript. All scripts from sgizmo.com, surveygizmo.com and cloudfront.net should not be blocked.

• There is a possibility to save your survey at any time by clicking "Save and continue survey later" on top of the screen. Please bear in mind that only the entered data on previous pages will be saved. In order to save the data on the page you are at that moment, continue to the next page and save there.

• On the last page there is a special field where files (documents, pictures, PDF, etc.) can be uploaded.

• If you have any problems or questions, please don't hesitate to contact Florian Krouwel of the WMDA Office: krouwel@europdonor.nl

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