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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.


SPEAR 2.0 continued updates

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. 

Content of this user 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

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.

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.

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 1-2. 

  • 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.


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 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 (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

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.   

Drafting a report (reporter)

  • 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.

    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 (reporters)

  • 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 

    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 (reporters)

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 (reporters) 

Adding additional information to a report (reporters)

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

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.

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. 

Download 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.


Figure 6: Export reports button

Figure 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". 

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. 

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:

  1. Go to the additional information requested table in your dashboard when you’re logged in
  2. Click View to view the comments made by the medical advisor that require your input. Assess whether the comments would require for you to edit the report.
  3. Go back to the additional information requested table in your dashboard
  4. Click on Edit to make the changes to the report you wish to make AND to submit the report to WMDA again at the Submit page.
  5. Now that the report is re-submitted, you’ll find it at the Submitted to WMDA table in your dashboard
  6. To make a comment (in reply to the comments from the medical advisor, for example) you can click the Comment button if the report is in the Submitted to WMDA table.



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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