Step 1a: Design the Adverse Event form

When do I do this? At any time during study design, as long as the Safety and Data Management teams have agreed on what data should be sent from InForm to Argus.

Why should I do this? To collect adverse event data, which will be sent to Argus Safety.

You can design the study so that all the adverse event information is on a single Adverse Event form. Or, you can design multiple Adverse Event forms if you have different versions of the form for pregnancy or other types of adverse events.

At the bottom of the Project Explorer, click the Visit Schedule () button.
Right-click the study event to which you want to add the Adverse Event form to, select New, and select Form.
Study events are designated by the Study Event icon ().
Enter a Title, RefName, and Description, and click OK.
Tip: Form RefNames are used as the column header in Reporting Data Extracts, and are also used by rule writers to identify the correct study object to use in a rule.
In the Project Explorer, select the new form, and make sure the Design tab is selected.
In the upper-right above the grid, select the Repeating checkbox.
Note: To ensure that data is captured and maintained properly, do not change these settings after you have deployed your study. If you need to make changes, deactivate this study object and create a new object with the updated settings.
In the grid, add adverse event items. You must include a date/time item to capture the onset date of the adverse event.
In addition to the other adverse event items you include, define the following required Yes No items that trigger rules to initiate the transmission of the adverse event data.
- Serious (the item will be reported). The question might be: Was this a Serious Adverse Event?
- Reportable (the item is not serious but should still be reported). The question might be: Should this event be reported?
For each of these items, follow these guidelines:
- For Type, select Yes No Item. This type includes a built-in codelist that allows the user to select Yes or No.
- Enter Title, RefName, Question, and Short Question. For example: Reportable, Report, Is this a non-serious event, but still should be reported?, and Report?
- Select the Item Req checkbox.
Whether you have one adverse event per case or associate multiple adverse events with an Argus case, you must specify a sequence ID for the item by creating a read-only integer AEID field with a rule that calculates and assigns a sequence ID.
- This is one of two ways you can associate multiple adverse events with a Safety Case form. The other is to set up time frames for sending data in InForm Publisher.
- See an example of the rule in Calculate the safety case-related sequence ID.
Next, add rules to the form to specify whether to transmit safety event data immediately or at a configured interval.

Tips:

If this is the first form in a visit, you must include the Date of Visit item if you are planning to use the Enforce visit date entry system configuration option in InForm.
If this is the first form in a repeating visit, you must include the Date of Visit item.
We recommend that you include 20 or fewer items on each form, and split any extensive data capture requirements across multiple forms. Although there is no predefined item limit in Central Designer, including 20 or fewer items per form ensures optimal system performance and prevents impact on integrated or downstream applications. For example, an in-place revision on a study that contains a large form might create a database table with more than 1000 columns. As a result, the study deployment fails because the number of columns exceeds an Oracle database column limit.