SPEAR User Guide

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. 

  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 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

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 2) 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 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 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

When 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

Review process of the committee 

Download report overview

Print a report

Frequently Asked Questions (FAQ)

GENERAL

USING THE SPEAR REPORTING TOOL

SPEAR REPORTING 101

CASE STUDIES

to be updated