Where and how do I manage the (S)AEs?

Learn where to find the (S)AE overview and how to sign them.

(S)AE Overview

You will find the (S)AE module in the left sidebar marked with a ⚠️. If you click on it, you will be directed to the (S)AE overview.

	There are different tabs to access either all (S)AEs, the (S)AEs to be signed or the ones created by you.
	By default, you will see all standard columns available, also depending on the functionalities used. The serious status of an adverse event is calculated based on available field values and the general study definition set-up. You can click on the different columns to get more detailed insights in a pop-up (e.g. progress, signatures). The queries column gives you insights on the number and status of the queries per (S)AE. You will be redirected to the queries when clicking the query icon.
	With the filter widget, you can filter all (S)AE entires based on (S)AE specific information and field values. All search and filter queries can be saved and reused as smart filters by clicking the star icon (similar to the study overview).
	Table Preferences I: If the user has the respective rights, the default system view for all collaborators can be updated. Also, new public and private views can be created.
	Table Preferences II: For each view, columns can be shown or hidden, so that collaborators only see the information relevant to them. Also, up to three custom fields from (S)AE forms can be displayed in the (S)AE overview which enable collaborators to get a better overview.

How do I sign (or lock) an (S)AEs? 

There are two ways to sign or lock an (S)AE.

1) Signature (or locking) via form

For each (S)AE form requiring a signature(s), you will see the pen icon next to the form tab when opening the respective (S)AE. Click on it to add the electronic signature. 

The next step is to click on the green button "Record signature" and a new window will pop up: 

If you are authorized to sign the (S)AE, proceed by entering your password and click save at the end. The pen will automatically change to either yellow if another signature is required from a different user, or green if all required signatures have been completed.

For locking, you will see a lock symbol next to the respective form. The form can be locked and thus prevented from further editing by confirming and providing a reason for the locking action.

2) Signature (or locking) via the (S)AE overview

If the study set-up allows for bulk signature and/or locking, you can simply sign/lock all open forms by selecting respective (S)AEs in the (S)AE overview, click on the Actions button and select "Sign/Lock (S)AE". For signatures, you need to confirm your signature with your password (see above).

Read the following article for further information on bulk signature: How do I sign/unsign an input form?

Videos

How to update an (S)AE

You had to pause while making your (S)AE entries or want to make changes or updates to an already reported (SA)Es? In this video we will show you how you can easily locate previously documented (S)AEs to edit them.

How to 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.