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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 andtherefore 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.

Other useful documentation and external links

• Access the SPEAR online reporting tool
• Examples of SEAR/SPEAR reports
• WMDA Imputability Assessment Tool
• Educational webinar on SPEAR reporting (March 2020)
• Operating of the SPEAR Committee
• Standard Operating Procedure for reporting SEAR/SPEAR
• Common Terminology Criteria for Adverse Events (CTCAE) v5.0
• International Statistical Classification of Diseases and Related Health Problems 10th Revision 
• Notify Library

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Important information

• The SPEAR reporting tool is a web-based application, thus it may be subject to delays depending on the speed of the internet connection and server load. If you are not able to access the login screen of the application, please check that your internet connection is in proper working order.
• The SPEAR reporting tool is secured using HTTPS. Because of this all communications between the web browser and server are encrypted, guaranteeing data privacy and security.
• The SPEAR reporting tool is accessible at all times unless it is unavailable as part of any upgrades or maintenance work. 
• The SPEAR reporting tool is only available in the English language.
• Next to some questions you can find an Image Modified icon with more explanation on what type of answer is requested.

Questions are divided into the following subjects:

List of content

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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

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 4). After logging out of the system, you will be redirected to the login screen. 

Submitting a report to an affiliated (parent) organisation

Receiving a report from an affiliated (child) organisation

Submitting a report to the WMDA

Adding an attachment to your report

Saving a draft report 

Adding additional information to a report

Review process of the committee 

Providing updates to a report

Download report overview

Print

Download .csv file//insert content overview

GENERAL

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