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Introduction

The WMDA believes that donor The World Marrow Donor Association (WMDA) places great importance on the health and safety are of critical importance to of donors. To ensure the continued viability success of the global infrastructure of volunteer donors andtherefore requires donor network, the WMDA asks 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.

any serious events or adverse reactions (SPEARs).

WMDA hosts an online reporting service for SPEARs related to stem cell donation by unrelated and related donors or affecting product quality, this reporting system has been operational since 2003. Reporting of such incidents is a requirement of donor registries and cord blood banks seeking WMDA certification. Organisations in full compliance with WMDA Standards are required to report: 

• Any adverse event or reaction in connection with a donation affecting the donor, recipient, or product quality. (Well-known side effects and quality deviations do not have to be reported if mild and no serious consequences). 

• Any malignancy, severe autoimmune disease, or donor death (unless definitely not related) within 10 years of stem cell donation (“WBMT Minimal Data Set A”).

Reporters are asked to categorise reports as: 

• Harm to donor: an adverse reaction in a donor during or after a donation procedure, including unnecessary procedures. 

• Harm to recipient: an adverse reaction in a recipient during or after the infusion of a cell therapy product including any harm as a consequence of product quality issues, delay in delivery etc.  

• Risk of harm (an adverse event): any problem or incident that could have had (but did not have) negative consequences for the donor or recipient or the system as a whole. 

A committee of registry and cord blood bank experts assess the reports and evaluate imputability and impact. A rapid alert system is used for rapid dissemination of information to members of the international stem cell donor community in cases of critical importance. Annual reviews are prepared to share awareness of adverse events and reactions related to donation.

You can find answers to common questions on the SPEAR reporting service in the user guide below. 

Content of this guide 

This user guide is designed to assist new and existing users in navigating and utilizing the SPEAR reporting service effectively. Its coverage of the most important 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 service, ensuring that you have the information you need to use it to its fullest potential.

List of content

Important to remember 

• If you have an incident that requires quick dissemination as a rapid alert to the international community, you must 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 service must be limited to only the required data elements, omitting any identifiable data that is not necessary for report analysis. This means that any information entered into the SPEAR report (text and uploaded documents) should be free from (e.g.) names of donors, patients, staff, phone numbers, address, dates of birth, and any other information that can lead to the identification of a natural person. 
• SPEAR reports may contain sensitive information and therefore only persons currently working at the reporting registry and/or their affiliated organisation(s) should have access to this data. Organisations are responsible for communicating personnel changes to WMDA to restrict access to SPEAR in a timely manner. Any data downloaded from the SPEAR online reporting service should always remain confidential and should be treated as such. 
• When using the service, you agree to the WMDA Terms of Use and Privacy Policy.

Becoming a SPEAR reporter

If you are not yet a SPEAR reporter and would like to be, please send an email to sear-spear@wmda.info. Include the following information:

• Your full name (mandatory)
• Your title(s) (optional)
• The organisation you will be reporting for (mandatory)
• If known: if your organisation reports directly to WMDA or via a parent organisation (optional)

Once your request is received, WDMA will verify your details directly with your organisation before granting access to the SPEAR reporting service. Once your account is active, you will receive a welcome email with all login details. 

If you are a designated individual at a parent organisation, you can request an account for a new user at a child organisation. Please include the same details as listed above, and if applicable, include the IONs as well.

1. Getting started

You can go to https://spear.wmda.info and use your email address to log in. Below more details on accessing the service.

If this is your first time accessing the SPEAR service, you will need to ensure you have multi-factor authentication (MFA) set up with WMDA.

Step 1: verify your existing MFA access

1. Do you already have an active Search & Match user account with MFA access set up? Then you do not need to take any action and can access SPEAR immediately.
2. Do you not have an account set up with WMDA (e.g. for Search & Match) that uses MFA? Please setup your new user account including MFA following the steps below:

1. 1. Click on the link: WMDA Service password reset
   2. Confirm your e-mail address and set your password
   3. When you are done with setting up your password go to: https://portal.wmda.info/
   4. Click on “Partner Sign in” in top right corner
   5. Enter your email address as username
   6. Enter the password you set up earlier
   7. Click “sign in”
   8. Follow the steps to add this account to your authentication app on your mobile device
   9. Once complete, confirm that your MFA credentials allows you access to https://spear.wmda.info/
      
      

Step 2: logging in

Now that your MFA is set up correctly, you can log in with your email address (user name) and password by clicking the blue Login button on the home page. 

Note: only if you or your organisation has specifically chosen the B2B login method, use the arrow next to the blue Login button on the home page to access B2B MFA login. Click here for more information on the B2B login method.

Step 3: selecting a role

• Step 1: Login to the SPEAR reporting with your MFA (see above). 
• Step 2: If you have multiple roles available to you, you will now see a "role selector" panel (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.  
  
  

1.3 Switching between roles (when logged in)

If you have multiple roles available to you, you can easily switch roles without logging out. The steps below explain how.

• Step 1: At the top of the page, on the right, you find your personal menu (figure 3). Click on your name to expand it.
• Step 2: Click this Switch Role option (figure 4) and you will be redirected to a new page where you can select the roles available to you.
• Step 3: Confirm the selection of the role you want by clicking the Select button (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 service in the role you selected. 

1.4 Logging out

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. 

2. Actions within the SPEAR reporting service

The SPEAR reporting service is used for three main goals: 1) as a platform for reporters to submit incident reports, 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, each with different rights and responsibilities. The role you have (selected) determines the amount of data and detail of data you can view and/or edit.   

2.1 Drafting a report (reporter)

• Step 1: Login to the SPEAR online reporting service with your username and password (see chapter 1). 
• Step 2: Choose the role of reporter with the correct organisation when you login to create reports (see chapter 1, step 3) 
• Step 3: Click the Create report button at the top of the page to start a new 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 form fields (or tabs) will 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). 
  
  

2.2 Adding an attachment (reporter)

• 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 

• Step 5: After selecting the files to upload, you must check the checkbox (figure 10) underneath the file overview to confirm that you are not uploading any identifying personal information, such as names or any other identifying information belonging to donors, patients or staff.
  
  

2.3 Submitting a report (reporter)

Once you've filled out all required information, you are ready to submit the report. 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 affiliated parent organisation first, before it is sent to WMDA.

The last tab of the SPEAR report, labeled "Submit", provides a summary of the report details you've entered. 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." 

2.4 Receiving a report from an affiliated (child) organisation (reporter) 

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 service. 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). 

2.5 Adding additional information to a report (reporter)

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. 

• Step 1: Click on the report to open it (figure 14).
• Step 2: If editing is available, at the top of a page there is a Edit Report button (figure 15).
• Step 3: When finished editing, make sure you click the “Submit Report” Button to resubmit the report.
• Step 4: If you want to add a comment, scroll down to the bottom of the report page when viewing the report details to add your comments (figure 16).
• Step 5: Please re-submit the report to WMDA when done, by clicking the Submit Report button. Only then will the report by reviewed again by the Medical Advisor and SPEAR Committee.
   

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

As long as a report has not been marked as "reviewed by committee", there is the possibility to add information via the SPEAR service. You can click add comment or edit report to do so. If a report has already been reviewed, or is submitted to WMDA, but you have crucial information to add, please email sear-spear@wmda.info to request to add the details to the report. Each request will be reviewed on an individual basis.  

2.7 Review process of the committee (committee member)

The SPEAR committee is a group of medical experts from around the globe that review all notable SPEAR reports submitted to the WMDA. This committee meets on a bi-monthly basis. The committee may decide that a report requires additional information to be able to complete the report 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 reviews reports to determine 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.  

2.8 Download report overview (all users)

Users can download an overview of reports of their organisation via the SPEAR service. 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:

• Step 1: Click on Other Actions button at the top of the page (figure 17)
• Step 2: In the drop down menu, select Export Reports.
• Step 3: Determine if you want to download all reports or only the reports of a certain status (e.g. reviewed by committee) (figure 18) 
• Step 3: In the pop up window, select the file format you'd like to download (figure 18)
• Step 4: Click download. You will be sent back to the report overview where you can see the progress of the download.
  
  

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.

2.9 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". 

Since April 4th 2022 the new SPEAR 2.0 reporting tool is in use. 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 bare 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. 

Content of this user guide 

This user guide provides you with instructions on how to use the SPEAR online reporting tool. It is designed to assist you with using the features of the SPEAR reporting tool to submit SPEAR data to the WMDA in the easiest way possible.

List of content

Getting started

Accessing the SPEAR reporting tool

You can access the SPEAR reporting tool via web address (or URL) by entering the address in your browser: https://spear.wmda.info. You can save a bookmark in your browser, e.g. for the SPEAR reporting tool, so that you are immediately directed to the login page. Click on the 'Forgot Password' as indicated with a red box in figure 1, fill out your e-mail address (this field is case sensitive) on the reset password page of figure 2 and click on the 'Send Password Reset Email' button. You will then receive an e-mail with a link to set your new password. 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 same steps. 

Changing your password

Follow the steps described above to access the system for the first time.

• Step 1: Click on the link 'Forgot Your Password?' at 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
  title Password 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 1-3.

• 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.

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. 

• Step 1: Login to the SPEAR reporting with your username and password. 
• 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 (figure 3).
• Step 3: Click this Switch Role option (figure 3) and you will be redirected to a page where you can select the roles available to you.
• Step 4:Select the role you want and click the Select button. To confirm the role switch, a message will appear "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.

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. 

Actions within the SPEAR reporting tool

Drafting a report

• Step 1: Login to the SPEAR online reporting tool with your username and password. Don't have a username and password 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 reports
• Step 3: Click Create new report at the top of the page under Report list to start a new draft 

• 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.

  Note
  title Change 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

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

  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.

Submitting a report

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.  

Receiving a report from an affiliated (child) organisation

Adding additional information to a report

Providing updates to a report that as already been reviewed by the committee

Review process of the committee 

Download report overview

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:

• Step 1: When you are logged in to the correct role in SPEAR, scroll to the bottom of the page to find the download buttons (figure X)
• Step 2: Click the button for the desired file format (JSON or CSV)

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.

Print a report

GENERAL

USING THE SPEAR REPORTING TOOL

Do you have questions on how to use the SPEAR reporting tool service or do you want to report an issue? Please use the button below.