Step 1c: Design a Safety Case form

When do I do this? After you have created the Adverse Event form and other relevant forms to send to Argus Safety.

When do I need a Safety Case form? If you want InForm site users to be able to group multiple adverse events that relate to a single Argus case and report them together, you must include a Safety Case form. If each Adverse Event form becomes an Argus case, or you have configured InForm Publisher to send adverse events automatically based on their date of occurrence, you don't need a Safety Case form. The site user selects the items to send on the Safety Case form.

At the bottom of the Project Explorer, click the Visit Schedule () button.
Right-click the study event to which you want to add the Safety Case 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.
Create a non-repeating section and add items that relate to the Argus case as a whole. You might include an item that triggers the case to be sent to Argus when the user submits the form by adding a question such as "Is this ready to be sent to Argus?"
Create a repeating Adverse Event section and add adverse event items that will help the site user identify the specific adverse events that they want to group together and submit as a single Argus case.
Note: If you enter multiple AEs on the Safety Case form, the onset date will be the onset date of the earliest AE marked as Serious. Or, if all non-serious AEs were selected, it will be the earliest onset date of any AE.
In the Adverse Event section, add an integer item (AEID) for the InForm site user to type in the sequence ID assigned when the Adverse Event form is submitted.
Create other repeating sections (Concomitant Medications, Medical History, Labs, etc.), and group items together to submit to a single Argus case by adding integer items (CMID, MHID. etc/) for the InForm site user to type in the sequence ID assigned when the form is submitted.
Note: If you map the SE Related AE Sequence Number Control to an item in a repeating itemset, timeframe for related AEs will not be used.
Next, add rules to the form to specify whether to transmit safety event data immediately or at a configured interval.

Tips:

The amount of data copied onto the Safety Case form differs based on the type of source form. For example, for adverse events, copy over only the information the site needs to confirm that they selected the correct AE. All other information about adverse events that needs to be sent to Argus can be mapped directly from the Adverse Event form and does not need to be copied. For AEs, the data can be split between forms to go to Argus Safety if you are using InForm Publisher 2.1.1 or higher.
For forms other than AEs (Medical Hx, labs, etc.), the data cannot be split between forms to go to Argus Safety if you are using InForm Publisher 2.1.1. You must put ALL items that need to go to Argus Safety on the Safety Case form.