The World Marrow Donor Association (WMDA) places great importance on the health and safety of donors. To ensure the continued success of the global donor network, the WMDA requires its members to report and investigate any serious events or adverse reactions (S(P)EARs). The WMDA has been collecting this data since 2003 and has provided an online reporting tool for this purpose.
For help with the SPEAR online reporting tool, you can find answers to common questions in the user guide. If you have technical difficulties and cannot find a solution in the guide, you can ask a question using the question box at the bottom of the document or reach out to the WMDA office at sear-spear@wmda.info. You can access the SPEAR online reporting tool by clicking here.
In 2022, the WMDA IT infrastructure incorporated the SPEAR reporting tool. A dedicated IT team developed an in-house solution, which was released in April of that year. Since then, it has undergone updates to enhance the reporting experience. The user guide is subject to change as a result of ongoing improvements. We appreciate your patience while we work on improve the reporting experience for all users. To report issues or ask questions not covered in this guide, please use the question panel below or email us at sear-spear@wmda.info. |
Useful documentation:
External links: |
This user guide is designed to assist new and existing users in navigating and utilizing the SPEAR reporting tool effectively. Its comprehensive coverage of all the features and functions of the platform will help you get the most out of SPEAR, making it easier for you create, submit and edit reports. Whether you are a beginner or an advanced user, this guide will provide you with a complete understanding of the SPEAR reporting tool, ensuring that you have the information you need to use it to its fullest potential.
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To access the SPEAR reporting tool, type "https://spear.wmda.info" into your browser's address bar. To make it easier to get to the login page, you can save a bookmark in your browser.
If this is your first time accessing the SPEAR tool, you will need to ensure you have multi-factor authentication (MFA) set up with WMDA.
Step 1: verify your existing MFA access
If you get stuck, please consult the MFA user guide (https://share.wmda.info/x/yAl6G). If you can’t resolve the issue, you can contact the WMDA support team by sending an email to support@wmda.info. Please include the URL, what you are trying to do and a screenshot of the error.
Step 2: logging in with MFA
If you have multiple roles available to you (e.g. you are a SPEAR reporter and a SPEAR committee member or you are a SPEAR reporter for multiple organisations) then every time you login to the SPEAR reporting tool you have to select the role you initially want to access the tool with.
Many users will only have 1 role (reporter) assigned to them. If this is you, you will not see the role selection panel after login, but instead you will automatically be directed to your report overview. You can skip this section of the user guide. |
If you have multiple roles available to you, you can easily switch roles without logging out. The steps below explain how.
1.4 Logging off
To close and exit the application click on your personal menu at the top of the page (figure 3). A menu will appear that has the Logout option (figure 6). After logging out of the system, you will be redirected to the login screen.
The SPEAR reporting tool is used for three main goals: 1) as a platform for reporters to submit possible SPEAR cases, 2) as a tool for the SPEAR committee to assess and review reports that are submitted and 3) to provide a central current database of adverse events and reactions for data analysis and research purposes. This is why there are a variety of roles available within the platform. The role you have (selected) determines the amount of data and detail of data you can view and/or edit.
You can always change the Type of report by going back to the first tab (Type of report). If you change the type of report selected, different follow-up questions might appear. Answers previously given can be automatically erased if they no longer are part of the question list belonging to the new Type of report you selected. |
Step 4: Click the Upload files button to select the files to upload from your computer. You can select multiple files from the same folder at once by using CTRL + click or by dragging your cursor
Step 5: After selecting the files to upload, you must check the checkbox (figure 10) underneath the file overview to state that you are not uploading any identifying personal information, such as names, dates of births or any other identifying information belonging to donors, patients or staff.
For every file you upload, you have to check the checkbox stating that the files you are uploading do not contain any personal information. Personal data are any information which are related to an identified or identifiable natural person. The data subjects are identifiable if they can be directly or indirectly identified, especially by reference to an identifier such as a name, an identification number, location data, etc. In practice, these also include all data which are or can be assigned to a person in any kind of way. For example, the telephone, credit card or personnel number of a person, account data, number plate, appearance, customer number or address are all personal data. For more information on personal data according to the GDPR, please click here. |
Once you've filled out all required information in the report, you are ready to submit it. Depending on if your organisation is affliated or not with a parent organisation (like a national donor registery), the report either goes directly to the WMDA or is submitted to the affilaited parent organisation first, before it is sent to WMDA. On the last tab of the SPEAR report, labeled "Submit", provides a summary of the report details. In case 1 or more mandatory field(s) is left empty, the report cannot be submitted. The Submit page will then display an error message at the top and request that you supply the missing mandatory details (figure 11). If no mandatory information is missing and you are pleased with the report as is, scroll down to the bottom of the page and click "Submit report."
If your organisation has affiliated organisations, eg. a national donor registry with local transplant or collection centres, it could be that you receive reports from these organisations via the SPEAR tool. It is then your responsibility to review these reports and to submit them to the WMDA on their behalf. An overview is available in a table on your dashboard named "Submitted to this organisation" (figure 12). Please review the reports there in a timely manner. You can proceed to submit to the WMDA by opening the report to view its content and click the "submit to WMDA" button at the bottom of the page (figure 13).
If a report has been submitted, it could be that you wish to add additional information or that the SPEAR Committee has a follow-up question or a request for more details. To add information to an existing report, there are 2 options, 1) you add details via de comments section or 2) you edit the report to add the details to the report overview. Information added directly to the report (by editing) is the preferred to enter data corrections or additional information relevant to the assessment of the report. Comments are best used to communicate with the SPEAR Committee and answer any question that they might have.
As long as a report has not been marked as "reviewed by committee", there is the possibility to add information via the SPEAR tool. You can click add comment or edit report to do so. If a report has already been reviewed, but you have crucial information to add, please email sear-spear@wmda.info to request to add the details to the report.
The SPEAR committee is a group of medical experts from around the globe that have the responsibility to analyse and classify all SPEAR reports submitted to the WMDA. This group meets on a monthly basis to discuss notable reports. The committee may decide that a report requires additional information to be able to complete the assessment or classification of a report. If so, the reporter receives this question via comments on the report. Once a report is complete, the committee assesses the report determines the necessary follow up (if any). Once a report is reviewed by the committee, the review details are available to the reporter for viewing in the "Reviewed by Committee" table.
Users can download an overview of reports of their organisation via the SPEAR tool. Two file formats are provided for download: .csv (Comma Separated Value) file and .json (Javascript Object Notation) file. For regular use, we recommend choosing the .csv file for download as it is easily converted to an Excel file. In case you want to use the SPEAR data for IT applications: JSON is supported by all the programming languages like Java, Net (C#), PHP, etc.
JSON is a data exchange format that stands for JavaScript Object Notation with the extension .json. JSON is known as a light-weight data format type and is favored for its human readability and nesting features. It is often used in conjunction with APIs and data configuration.
CSV is a data storage format that stands for Comma Separated Values with the extension .csv. CSV files store data values (plain text) in a list format separated by commas. Notably, CSV files tend to be smaller in size and can be opened in text editors.
Please follow the steps below to download an overview of reports:
Currently downloading a .csv file will take a long time if you have a lot of reports included in the overview. Please go grab a cup of coffee and check back in a few minutes if the download is complete. Once it's done, you will likely find it in your downloads folder on your computer. |
Converting a .CSV file to an .xslx (Excel) file:
When you click the View option to open a report and view its details, a button will appear at the top of the page: "Print report".
The WMDA follows the EU definitions of a serious adverse event or reaction: Definition serious adverse reaction (SAR): An unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity. Definition serious adverse event (SAE): Any untoward occurrence associated with the procurement, storage and distrubution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-greatening, disabling or incapacitating conditions for donors or patients or which might result in, or prolong, hospitalisation or morbidity. Criteria for serious adverse event (SAE):
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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. |
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:
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No, SPEAR accounts are intended for use by one person. A shared account would mean a shared password and this brings numerous security risks along with it. For example, if an employee leaves the organisation, they would still have access to highly sensitive SPEAR data because the username and password are known to them. Sharing passwords in any way, via email, post its, etc., should of course always be avoided at any cost as it creates the opportunity for an unwanted third party to gain access. We do not mind creating multiple accounts, it actually makes it easier to manage if someone leaves or joins your organisation. SPEAR users from the same organisation also all have access to the same report data (e.g. draft reports can be started by 1 user and finished by another). |
USING THE SPEAR REPORTING TOOL
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. |
The WMDA follows the Common Terminology Criteria for Adverse Events (CTCAE) guidance for severity assessment. For a quick overview of the possible adverse reaction severity grades to choose from, please use this page. |
The WMDA has developed an imputability assessment tool to help you determine the imputability grading most fitting with your adverse reaction report. |
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. |
Please see page 15 in this publication by IQVIA for a summary of EMA information for approved indications for G-CSF products |
The aim of the Rapid Alert System is to transmit only those cases whose urgency and seriousness cannot permit any delay in transmission. For example, in case of recall or if there's a big risk for future donations or transfusions, a report can be submitted as a rapid alert. The rapid alert system ensures a timely, proportionate, accurate and consistent response to adverse occurrences arising from donation or transplantation which represent a significant threat to the international transplant community. This includes, but is not limited to:
If you have a rapid alert 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. |
CASE STUDIES
to be updated
Ask a question on SPEAR reporting
Do you have questions on how to use the SPEAR reporting tool or do you want to report an issue? Please use the button below.