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SPEAR 2.0 continued updates

Since April 4th 2022 the new SPEAR 2.0 reporting tool is in use. This tool will continue to receive updates and therefore the content of this user guide is subject to change along with the updates that are implemented. 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. 

Introduction

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, but i you encounter any technical difficulties in using the system and cannot resolve them by reference to this user guide, please contact the WMDA office at sear-spear@wmda.info.  The SPEAR online reporting tool can be accessed here.


Content

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: 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 (figure 2), enter your e-mail address and click on the 'Send Reset Password Email' button. 
  • Step 3: Click on the link in the e-mail you received from the system. 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 4: Choose a new password, confirm your new password and click on the reset password button (figure 3).
  • Step 5: Go back to the login screen and enter your e-mail address and your new password.

Switching roles

If you have multiple roles available to you (e.g. you are a reporter and a committee member), then you can easily switch roles without logging out. To switch roles click on the three dots next to your name on the top right side of the page. A menu will appear that has the Switch Role option (figure 4). When you click this option, you will be redirected to a page where you can select the roles available to you. 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 (figure 5) to go to the dashboard overview.

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. 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. 

Actions within the SPEAR reporting tool

Drafting a report

Adding an attachment to your report

Submitting a report

Receiving a report from an affiliated (child) organisation

Adding additional information to a report

Providing updates to a report

Review process of the committee 

Download report overview

Print

Download .csv file

Frequently Asked Questions (FAQ)

GENERAL

The WMDA follows the EU definitions of a serious adverse event or reaction: 

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. 




USING THE SPEAR REPORTING TOOL

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. 




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:

  • 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





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