How do I set up (S)AE input forms and the (S)AE workflow?

Learn how to create an (S)AE form & update (S)AE workflow settings in step 3 & 4 of your study set-up.

1. Step 3: Forms

In step 3 ("Forms") you can create and edit your (S)AE forms. Click on "Create new form" to either select a pre-set and published template or create a new form from scratch. 

"Input Form Settings" are the first part of the form settings.

	Here, you can enter a name, export name and description for the (S)AE form.
	Each form can be shared either with the study or all studies/surveys on the instance for further use.
	Excluded collaborator roles can be selected to prevent certain users to access and view this form when used in the (S)AE workflow. They won't see this form in the export as well.
	The signatures functionality is discussed in more detail in another article. See here: How do I set up the signature function for an input form?
	The locking functionality is discussed in more detail in another article. See here: How do I set up the locking function for an input form?
	With this function, you can instruct the system to save the entered data only if all required input fields within this input form have been completed to 100%.
	The preview mode allows you to see what your form would it look like from the investigator's or monitor's point of view.

Further below, in the "Input Form Content" section, you can configure the form as flexible as our (un)scheduled events. 

	You can find pre-configured input field types that can be used or deleted. For deletion please mark the section and right click. Here you can choose to delete the section or merge it with other marked cells.
	You can add new input fields via drag and drop.

See also this article for more detail on how to build an input form.

2. Step 4: Workflow

In Step 4 of the study settings you can define the workflow and additional functionalities for the (S)AE module ((S)AE forms, Seriousness definition & Pre-filled fields).

	Similar to the scheduled events, you can select the (S)AE forms which have been created in Step 3. When reporting a (S)AE, the user will be able to see and fill the selected forms. Here, you can also modify the display label of the form and add input form dependencies.
	Depending on whether you set-up (S)AE forms which require signatures or locking, you can enable the functionality "Bulk locking/signature". When activating this toggle, collaborators with locking/signature rights will be able to lock/sign all open forms of selected (S)AEs via the Actions button in the (S)AE overview at once. Read the following articles for further information regarding bulk locking and signing: How do I sign/unsign an input form? How do I lock/unlock an input form?
	Here, you can define when a reported AE will be defined as "serious". You can add several conditions and connect them either via an AND or OR connection (similar to our trigger events). The serious state of a (S)AE will be calculated and shown based on the data inputs and the definition set here.
	Pre-filled fields can be used to add field inputs to (S)AE forms which have already been filled within the eCRF or ePRO before but are also relevant to be included in the (S)AE reporting (e.g. year of birth of the subject which has already been entered in the baseline visit of a study). These fields are shown within the (S)AE of a subject and are included in all exports of the (S)AE.