How and where do I create an input form for unscheduled events? (Step 3)

Modified on Fri, 25 Apr at 2:14 PM

Learn how to set up forms for unscheduled events.

⭐ The "unscheduled event" is a premium feature, which will be only visible if you have booked it.

What is considered as an unscheduled event? Depending on the set up of the study this is usually an event that happens out of the ordinary protocol of the study. This could include any additional important data about the subject e.g. blood samples, medical history, medication.

In comparison to scheduled events there are some features that do not apply for unscheduled events:

❌ tracking a reason of change

❌ including unscheduled events data in the subject overview & progress of patient (e.g. signatures & locking status, updated column, reference date)

❌ linking the status of a subject from scheduled events → i.e. when we set a subject to completed, the unscheduled events can still be modified and when the subject is re-enrolled, the scheduled events are not cleared

❌ benchmarking widgets

❌ filter unscheduled events in combination with scheduled events

❌ unscheduled ePRO’s, that can be either triggered manually through site or even the subject him/herself

❌ validations across unscheduled & scheduled events

❌ PDF export

Step 1:

After logging into the system, click on the study module.
Now you will see the study you wish to edit. Click on the "Settings"-button.

Step 2:

The editing overview of your study opens. Now click on step "3. Forms".
Select the tab "Unscheduled Events".
In this overview, you can see the most important information about the input forms you have already created.

⭐ The "Status" item helps you see whether your form has already been filled out for a subject within your study or not.

Step 3:

Click on the button "Create new form". A pop-up window will ask you whether you want to select a template or create a new blank form.
Select "Create blank form". The possibility of "Select template" is explained below.
A new window opens.
Two fields are marked as required for creating an input form (Numbers 1 and 2).

First of all, you need to give your input form a name (e.g. demographics). Please try to avoid copy-pasting the name and ideally exclude the following characters:

+ ' ; " . ? $ * [] / \

Furthermore, you must define an individual export label e.g. DEMO. If you export your data later on, this will be the corresponding label.

We recommend that you always copy the name of the input form into the description.

Why should I copy the name of the input form into the description?

When setting up the workflow, you can give the “tabs” a different name than the input form itself. For example if you add an input form that is called “Health Status” to your workflow you can name it “Visit 1”. When the input form “Health Status” also has the display label added into the description then next to the “Visit 1” will pop up a little information box to hover over. This will show you the description of your form. This is a very useful tool to know which input form you have integrated into the workflow especially if you use the same input form multiple times.

	Here you can determine whether this input form should be "published" at study level or even at instance level. If you toggle this function on, you can reuse this exact input form when creating a new one. All you have to do is click on "Select template" when creating a new input form. Then a window opens in which you can choose between the general and study-specific templates. Depending on your user rights, you might only see the option to publish it as a template within this study.
	In this field, you can select the roles that should not have access to this input form. You can see where to set up or modify the roles here.
	Signatures and locking are discussed in more detail in other articles. For this process, the roles must already be defined and entered in the system.
	With this function, you can instruct the system to save the entered data only if all required input fields have been completed to 100%.
	The preview mode shows you what your eCRF would look like from the investigator's perspective. This mode also allows you to easily identify any creation errors.
	After adding the input fields in the lower field, you can save the input form with the button "Create".

✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de.