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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 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.


SPEAR 2.0 continued updates

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. 
  • 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.


Figure 1: SPEAR login panel

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 tool as described 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 (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.


Figure 2: Access menu to switch roles

Figure 3: Select switch roles

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. 


Figure 4: Access menu to log out

Figure 5: Select log out

Actions within the SPEAR reporting tool

Drafting a report

  • Step 1: Login to the SPEAR online reporting tool with your user name and password by using the steps listed above. Don't have a user name 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.

    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, select 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 

    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.

    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

Print a report


Frequently Asked Questions (FAQ)

GENERAL

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

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:

  • 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. 


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

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

to be updated




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