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Introduction

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.


Warningtip
titleSPEAR 2.0 continued updatesReporting Tool Continued Updates

In 2022, the WMDA IT infrastructure incorporated the 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 . 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 . Please check back regularly if you are encountering issues you've not encountered before and bear with us as a result of ongoing improvements. We appreciate your patience while we work on optimizing improve the SPEAR reporting process.Have a question on the new features on want to report an issue? Please experience for all users. To report issues or ask questions not covered in this guide, please use the question panel at the bottom of this pagebelow or email us at sear-spear@wmda.info

Info
Other useful documentation and external links
titleUseful Documentation and External Links

Useful documentation:

  1. WMDA Imputability Assessment Tool
  2. Operating of the SPEAR Committee
  3. Standard Operating Procedure for reporting SEAR/SPEAR
  4. Examples of SEAR/SPEAR reports

External links:

  1. Access the SPEAR online reporting tool
  2. Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  3. Educational webinar on SPEAR reporting (March 2020)
  • Examples of SEAR/SPEAR reports
  • International Statistical Classification of
    1. International Statistical Classification of Diseases and Related Health Problems 10th Revision 
    2. Notify Library
  • WMDA Imputability Assessment Tool
  • Operating of the SPEAR Committee
  • Standard Operating Procedure for reporting SEAR/SPEAR
  • Content of this guide 

    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

    Table of Contents

    1. Getting started

    Accessing the

    Important to remember 

    • You can click the WMDA SPEAR reporting tool

    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.

    Setting and resetting your password

  • Step 1: Click on the 'Forgot Password' button on the SPEAR login screen (figure 1).
  • Step 2: In the next screen, enter your e-mail address and click on the 'Send Reset Password Email' button.
    • logo on the top left of your screen to go back to the reports overview 
    • If you have an incident that requires quick dissemination as a rapid alert in our community, please contact the WMDA office directly by sending an e-mail at sear-spear@wmda.info and by phone on: +31 (0)88 505 7900.
    • Data submitted via the SPEAR reporting tool must be limited to only the data elements that are required for reporting. SPEAR reporters recognize the importance of protecting donor and patient privacy and will not share identifiable data to maintain the confidence and trust of donors, patients and regulators. 
    • When using the tool, you agree to the WMDA Terms of Use and Privacy Policy

    1. Getting started

    Accessing the SPEAR reporting tool

    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.

    1.1 Setting (first time!) and resetting your password

    • Step 1: Click on the 'Forgot Password' button on the SPEAR login screen (figure 1).
    • Step 2: In the next screen, enter your e-mail address and click on the 'Send Reset Password Email' button.

    Note
    titlePassword reset link expires

    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. 

    • Step 4: Choose a new password, confirm your new password and click on the reset password button.
    • Step 5: Go back to the login screen and enter your e-mail address and your new password.
    Imagefloat
    captionFigure 1: SPEAR login panel
    Image Added

    1.2 Choosing roles

    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. 

    Info
    titleOne or more roles

    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. 

    • Step 1: Login to the SPEAR reporting with your username and password (see above). 
    • Step 2: If you have multiple roles available to you, you will now see a "role selection" panel below the login fields (figure 2)
    • Step 3: Click on the role you wish to log in with at this time and click select. You are now directed to the report overview available to that role.  
    Imagefloat
    captionFigure 2: Access menu to switch roles

    Image Added

    1.3 Choosing roles when already logged in

    If you have multiple roles available to you,

    Note
    titlePassword reset link expires

    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. 

    • Step 4: Choose a new password, confirm your new password and click on the reset password button.
    • Step 5: Go back to the login screen and enter your e-mail address and your new password.
    Imagefloat
    captionFigure 1: SPEAR login panel

    Image Removed

    Switching roles

    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.  The steps below explain how.

    • Step 1: Login to the SPEAR reporting with your username and password (see above). Step 2: Click on the three dots next to your name on the top right side of the page (figure 2). A menu will appear that has the Switch Role option  At the top of the page, on the right, you find your personal menu (figure 3). Click on your name to expand it.
    • Step 32: Click this Switch Role option (figure 34) and you will be redirected to a new page where you can select the roles available to you.
    • Step 43: Select Confirm the selection of the role you want and click by clicking the Select button . To confirm the role switch, a message will appear (figure 5). You will be automatically re-directed to the report overview where a message appears: "Successfully switched role to XX at YY". You can now use the SPEAR reporting tool in the role you selected. Click on the SPEAR logo at the left top corner of the page to go to the dashboard overview.you selected. 


    Imagefloat
    captionFigure 23: Access Personal menu to switch roles

    Image RemovedImage Added

    Imagefloat
    captionFigure 34: Select switch roles

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    Imagefloat
    captionFigure 5: Panel to select role

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    1.4 Logging off

    To close and exit the application click on the three dots next to your name on your personal menu at the top right side of the page (figure 43). A menu will appear that has the Logout option (figure 56). After logging out of the system, you will be redirected to the login screen. 

    Imagefloat
    captionFigure 4: Access menu to log out

    Image Removed

    Imagefloat
    captionFigure 5: Select log out
    6: Logging off

    Image AddedImage Removed


    2. Actions within the SPEAR reporting tool

    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 via the tool and the actions you can carry outand/or edit.   

    Drafting a report (reporter)

    • Step 1: Login to the SPEAR online reporting tool with your username and password (see chapter 1). Don't have a username and password an account yet? Please see below at the FAQ: "How do I register as a SPEAR reporter?" 
    • Step 2: Choose the role of reporter with the correct organisation when you login to draft reportscreate reports (see chapter 1.2) 
    • Step 3: Click the Create new report button at the top of the page under Report list to start a new draft draft (figure 7). 

    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

    the form fields (or tabs) will

    become

    be filled with questions based on the type of report you selected. Depending on the type of report selected, fields are available or not and can be mandatory (or not). 

    Note
    titleChange the report type

    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. 

    Adding an attachment to your report (reporters)

    Step 1: If you haven't done so yet, start by selecting a Type of report at the

    Type of report you selected. 

    Imagefloat
    captionFigure 7: Creating a report

    Image Added

    Adding an attachment to your report (reporters)

    • Step 1: Open the report you want to attach the file to by 1) opening an existing report or 2) creating a new draft report. 
    • Step 2: Go to the Finalisation tab (figure 8)
    • Step 3: Locate the text "Upload any documents...." (figure 9)
    • 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 

    • tab first
    • Step 2: Go to the Finalisation tab
    • Step 3: Scroll down to "Upload any documents.."
    • 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 

      Note
      titleFile types and sizes
      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 (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.

    Warning

    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

    For more information on personal data according to the GDPR, please click here

    Imagefloat
    captionFigure 8: the finalisation tab

    Image Added

    Imagefloat
    captionFigure 9: the Upload files button

    Image Added

    Imagefloat
    captionFigure 10: GDPR compliance

    Image Added

    Submitting a report (reporters)

    Once you've filled out all required information in the report tabs, you are ready to submit the report. The last tab, labeled "Submit", gives a summary of what you've entered. If anything is missing, it will say so. If you see "This question is mandatory," go back to the indicated tab and answer the question. Otherwise, you won't be able to submit the report. If the summary page doesn't show any missing information, scroll down and click "Submit report." Depending on your organization type and your role, the report will be sent directly to WMDA or to your parent organization first.

    Receiving a report from an affiliated (child) organisation (reporters) 

    If your organization has affiliated organizations, eg. a national donor registry with local transplant or collection centres, it could be that you receive reports from these organizations to submit to the WMDA on their behalf. If so, they are listed in a separate table on your dashboard. Please review the reports there in a timely manner. You can proceed to submit to the WMDA by opening the report in "view" mode and click the "submit to WMDA" button at the bottom of the page. 

    Adding additional information to a report (reporters)

    If you've submitted your report, it could be that the WMDA Medical advisor or SPEAR Committee has an additional question or a request for more details. Usually, this request follows within a few weeks after submitting the report to the WMDA. Sometimes it can be after a much longer time due to new discoveries or new similar cases being submitted. To add the requested information simply follow the steps below.


    1. Log in to the SPEAR Online Reporting Tool
    2. Find the report in the “Additional Info Requested” table.
    1. Click the Eye Icon to view the report OR
    2. Click the Pencil Icon to make changes to the report. Click “Submit to WMDA” on the final tab to submit the report again to the WMDA.
    3. To add comments, click the Text Bubble icon.

    Providing updates to a report that has already been reviewed by the committee (reporters)

    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. 

    Review process of the committee (committee member)

    Download report overview (all users)

    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.

    Multimedia
    nameSPEAR_download_export_instructions (1).mp4
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    Please follow the steps below to download an overview of reports:

    • Step 1: When you are logged in to the correct role in SPEAR, scroll to the bottom of the page to find the Export reports button (figure 6)
    • Step 2: In the pop up window, select if you want to download all reports or only the reports of a certain status (e.g. reviewed by committee) (figure 7). 
    • Step 3: In the pop up window, select the file format you'd like to download (figure 7)
    • Step 3: Click download. You will be sent back to the dashboard report overview where you can see the progress of the download. 
    Warning
    titleDownload might take a long time

    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:

    • This two minute video explains how to open a .csv file in Microsoft Excel so you can use the data as a regular Excel file.
    Imagefloat
    captionFigure 6: Export reports button

    Imagefloat
    captionFigure 7: Select JSON or CSV download


    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". 

    Anchor
    faq
    faq
    Frequently Asked Questions (FAQ)

    GENERAL

    Expand
    titleDefinition of adverse events

    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):

    • The event (could have) led to inappropriate use of tissues or cells 
    • The event (could have) resulted in loss of the complete or significant quantity of irreplaceable cells 
    • The event (could have ) led to a serious adverse reaction (grade 2, 3 or 4)
    • The event (could have) led to misidentification or an unintended switch of cells
    • The event (could have) led to (an unforeseen) transmission of disease from donor to recipient
    Expand
    titleRole definitions and process flow

    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. 

    Expand
    titleHow do I register as a SPEAR reporter?

    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. 
    Expand
    titleCan I share my account with colleagues?

    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

    Expand
    titleWhat to report and what not to report?

    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.

    Expand
    titleHow do I assess the severity of the reaction?

    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

    Expand
    titleHow do I assess the imputability?

    The WMDA has developed an imputability assessment tool to help you determine the imputability grading most fitting with your adverse reaction report. 

    Expand
    titleWhat ICD-10 refence can I use?

    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. 

    Expand
    titleIs this mobilising agent a Filgrastim, Lenograstim or other?

    Please see page 15 in this publication by IQVIA for a summary of EMA information for approved indications for G-CSF productsproducts

    Expand
    titleReporting a Rapid Alert

    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

    Expand
    titleReporting a Rapid Alert

    In case of recall or if there's a big risks 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:

    • 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;

    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




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    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.

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