Recent Searches

No recent searches

    Popular Articles

      Articles

      View all

        Topics

        View all

          Tickets

          View all
            no results

            Sorry! nothing found for

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

            Modified on Fri, 25 Sep at 2:54 PM

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



            TABLE OF CONTENTS



            (S)AE Overview



            ⭐The (S)AE module is a premium feature, which will be only visible if it was enabled for your study. 


            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.



            The (S)AE overview can have several views. You'll find the details in step 4.

            The All data view shows every available column. Some columns, such as SDV progress, only appear if that feature is used in your study.

            • Serious: shows whether an (S)AE is serious. This is worked out from the entered data and the seriousness criteria set up for the study.
            • Progress, locking and signatures: click a value to see the details in a pop-up.
            • Queries: shows how many queries each (S)AE has and their status. Click the query icon to go to the queries.

            Forms and entered data

            • Completion per form: click the ">" arrow to expand one (S)AE or all of them. Each (S)AE form then gets its own column showing completion, locking and signature status.
            • Data of one form: pick the form from the All forms drop-down, or click the magnifier (+) next to the form name. The table then shows every field of that form with the entered answers. To go back, click the magnifier (−) or select All forms.
            • Open an (S)AE: click the file icon next to the (S)AE ID. The (S)AE opens in view or edit mode, depending on your rights.
            • Go to the subject: next to the subject ID, the file icon opens the subject's scheduled events and the person icon opens the subject profile.
            With the filter widget, you can filter all (S)AE entries 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).
            Views in the (S)AE overview

            Views let each collaborator see only the (S)AE information that's relevant to them. The overview always includes the All data view, which can't be deleted. Your last selected view is remembered the next time you open the overview.

            Create a view

            1. In the (S)AE overview, click + next to the view tabs.
            2. Under View settings, enter a name and choose who can see the view:
              • Private: only you.
              • Public: all collaborators.
              • Public default: all collaborators, and the view opens first. Only collaborators with the "Set public views" right can choose this option.
            3. Optional: switch on Colorblind mode. Locking and signature status is then shown as numbers instead of colored icons, e.g. 2/3 signatures.
            4. Under Show columns, switch on the columns you want to see.
            5. Optional: under custom fields, click Add field to show up to three fields from your (S)AE forms as extra columns. Each view can have its own custom fields.
            6. Click Save.

            ⭐ You can edit your own views at any time.

            ⭐ Predefined filtered views: "Created by me" and "To be signed" are available as predefined smart filters in the sidebar.




            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. 







            ✉️ Still have questions? Please contact your study coordinator.



            Was this article helpful?

            That’s Great!

            Thank you for your feedback

            Sorry! We couldn't be helpful

            Thank you for your feedback

            Let us know how can we improve this article!

            Select at least one of the reasons
            CAPTCHA verification is required.

            Feedback sent

            We appreciate your effort and will try to fix the article

            Preview
            0 of 0