How do I report an (S)AE?

Modified on Fri, 25 Apr at 2:09 PM

Learn how to report an (S)AE for a subject.

TABLE OF CONTENTS

Option 1 - Via the Subject Overview:
Option 2 - Via the Subject Profile/ Via Input Forms of the Subject:
Option 3 - Via the (S)AE Module:
Videos
- How to create an (S)AE via scheduled events
- How do I sign an (S)AE

⭐The (S)AE module is a premium feature which will be only visible if you have booked it. Please reach out to your sales contact person or your customer success manager if you are interested in it.

First, go to your subject overview.

Starting from the subject overview, there are three ways to create an (S)AE in Climedo.

Option 1 - Via the Subject Overview:

	Choose the subject you want to create an (S)AE for by ticking the box.
	Then click the button "Actions" and choose "Create (S)AE". The (S)AE form will pop up.

	The (S)AE is automatically assigned to the subject. The (S)AE ID will be created once data is entered and the (S)AE form is initially saved
	Within the blue bars, you see automatically pre-filled data for this (S)AE and subject which is filled after initial saving. Also the serious status will be displayed after initial saving of the (S)AE (Yes/No) and is calculated based on the entered data and the serious definition configured in the study set-up.
	Fill out all fields (and forms) of the (S)AE.
	Save the form. You will see the created (S)AE in the (S)AE overview.

Option 2 - Via the Subject Profile/ Via Input Forms of the Subject:

a. Within the subject overview, click on the subject symbol to access the subject's profile. There you will find an orange button "Create new (S)AE" on the right-hand side. The subject's information and the corresponding study will be completed automatically.

b. You will find the orange button "Create new (S)AE" also within the input form of an unscheduled or a scheduled event. The subject's information and the corresponding study will be completed automatically.

Option 3 - Via the (S)AE Module:

In the sidebar on the left, you will find the (S)AE module. Click on it to go to your (S)AE overview.

In the (S)AE overview, you will find the button "Create new (S)AE" on the right-hand side.

Select the subject via the SIC for which you want to create the (S)AE.

Find out where and how to manage your (S)AEs in this article.

Videos

Do you want to notify and document an (S)AE for a subject in our system? In this videos, we will show you each of three different methods to capture an (S)AE step-by-step. Please note that we recommend the first or second method.

How to create an (S)AE via scheduled events

First method

Second method

Third method

How do I sign an (S)AE

Once you have documented an (S)AE and saved your entries, you can sign the (S)AE form. This video will show you how to register a signature.

✉️ Still have questions? Please contact your study coordinator.