The WMDA believes that donor health and safety are of critical importance to ensure the continued viability of the global infrastructure of volunteer donors and therefore requires its members to report and investigate Serious (Product) Events and Adverse Reactions (S(P)EARs). The WMDA has been collecting data on serious events and reactions since 2003. In this 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 in the user guide below, but if you encounter any technical difficulties in using the system and cannot resolve them by reference to this user guide, please enter your question in the question box at the bottom of this document. Or contact the WMDA office at sear-spear@wmda.info. The SPEAR online reporting tool can be accessed here.
Since April 4th 2022 the current SPEAR reporting tool is in use. This is the first version of the SPEAR tool built by the WMDA IT team. It will continue to receive updates and therefore the content of this user guide is subject to change. Please check back regularly if you are encountering issues you've not encountered before and bear with us while we work on optimizing the SPEAR reporting process. Have a question on the new features on want to report an issue? Please use the question panel at the bottom of this page. |
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.
List of content
To access the SPEAR reporting tool, simply 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 create a password. Click on the "Forgot Password" button marked in red in figure 1. Fill out your email address (be careful, it's case-sensitive) on the password reset page in figure 2 and click the "Send Password Reset Email" button. You'll receive an email with a link to set a new password. Note that the password reset link will expire after 2 hours, so if you don't use it in time, you'll need to start the process again.
Please note: the link to reset your password expires in 2 hours. If you don't use it within that time, you must request a new password again by following the steps 1-2. |
Step 3: Click on the link in the e-mail you received from the system.
Every time you login to the SPEAR reporting tool, you select the role you initially want to access the tool with. 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 you can easily switch roles without logging out.
Logging off
To close and exit the application click on the three dots next to your name on the top right side of the page (figure 4). A menu will appear that has the Logout option (figure 5). After logging out of the system, you will be redirected to the login screen.
The SPEAR 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 determines the amount of data you can view via the tool and the actions you can carry out.
Step 4: Start your new draft report by entering the Type of report first. Once you've selected the correct type of report, the rest of the tabs will become filled with questions based on the type of report you selected.
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 paperclip icon to select the files to upload, you can select multiple files from the same folder at once by using CTRL + click or by dragging your cursor
Please note: only file with xlsx, .xls, .docx, .doc .pdf, .jpeg, .png, .gif, .tiff, .bmp, .txt extensions are accepted. Each file uploaded may not exceed 10mb. The maximum number of attachments may not exceed 5. |
Step 5: After selecting the files you wish to upload, you must check the checkbox underneath the file overview to state that you are not uploading any 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 requested information in the report tabs, you are ready to submit the report. The last Submit tab provides an overview of all the information you've entered in this SPEAR report. If any mandatory information is missing, this will be indicated here. If there is any red text "This question is mandatory" then you must go back to the tab this question belongs to and provide an answer. If you don't do this, the report cannot be submitted. If the report overview page shows no request for mandatory information, then your report is ready to be submitted. Scroll down to the bottom of the page and click Submit report. Based on your reporter type, the report will then be sent directly to the WMDA or first to your affiliated parent organisation.
You can download an overview of all reports in the SPEAR system of your organisation. 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. Please note that it feature does work, it will just require a long wait time. Please go grab a cup of coffee and check back in a few minutes if the download is complete |
Converting a .CSV file to an .xslx (Excel) file:
Print a report (all users)
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):
|
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:
|
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
Currently, if a report is in the Additional information requested table on your Dashboard when you’re logged in, you can choose to view or edit the report, but you cannot comment. The IT Team is currently working on updating the tool to allow for commenting in the additional information status of reports as well. A workaround, for now, is the following:
|
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 |
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:
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.