Step 1b: (Optional) Design other forms that may contain data to send to Argus along with the Adverse Event form

When do I do this? After you have created the Adverse Event form.

Why should I do this? This is how you send historical or clinical data to Argus as part of a case (for example, medical history, concomitant medications, lab test results).

At the bottom of the Project Explorer, click the Visit Schedule () button.
Right-click the study event to which you want to add the form to, select New, and select Form.
Enter a Title, RefName, and Description, and click OK.
In the Project Explorer, select the new form, and make sure the Design tab is selected.
To make this a repeating form, in the upper-right above the grid, select the Repeating checkbox. Continue with Step 6.
To make this a flat form with a repeating section, don't select the Repeating checkbox.
1. Expand the visit with the related form you want to add the section to, right-click the form, and select New Section.
2. Enter a Title, RefName, and Description, and click OK.
3. Make sure the Design tab is selected.
4. In the upper-right above the grid, select the Repeating checkbox.
To make this a flat form with a fixed, repeating section so you can send data the user doesn't enter:
1. Don't select the Repeating checkbox.
2. Expand the visit with the related form you want to add the section to, right-click the form, and select New Section.
3. Enter a Title, RefName, and Description, and click OK.
4. Make sure the Design tab is selected.
5. In the upper-right above the grid, select the Fixed and Repeating checkboxes:
6. Create fixed items in the section.
  1. In the Project Explorer, select a form or section, and select the Design tab.
  2. On the toolbar, click Columns, and display the columns that you need in the grid, including Codelist and Item Properties.
  3. In the grid, create items on the form or section by typing values in each field. Press Tab to advance to the next field and, when you have reached the end of a row, to the next item.
    Your changes are saved after you move the cursor away from the row.
    
    Note: Hidden items cannot be added to a dynamic grid section on the Safety Case form.
  4. To modify the properties of an item:
    1. In the Item Properties field, click Edit, or, on the toolbar, select Item Properties.
    2. Define the properties of the item. The fields that appear in the dialog box depend upon the type of item that you select. These properties are also available on the Design tab for an item.
7. For each item that you want to define as a fixed item:
  1. Add a codelist to the fixed item.
    1. On the bottom left of the page, select Forms and Transactions ().
      Tip: If your study uses codelist subsets, you can select a different subset for each item instance that uses the subset's parent codelist. Therefore, we recommend navigating to the item and codelist by first opening the form the item is used on.
    2. On the left, in the Forms folder, select the form or section that contains the item, and select the Design tab.
    3. In the grid, select an integer, text, or float item.
    4. Do one of the following:
      If the codelist already exists, select it from the drop-down list in the Codelist field.
      Create a codelist on the item.
    5. If codelist subsets are configured for the codelist, and you're required to select one, select the subset that you want to use.
  2. Add codelist items to the codelist.
    1. In the Project Explorer, select the Codelists Explorer bar.
    2. In the Codelists folder, select a codelist.
    3. In the rows and columns of the grid, type information about each codelist item to include in the codelist.
    4. After you complete each row, and after the final row, press Enter, or tab to the next row.
In the grid, add items.

Notes: 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.

If an in-place revision includes a form or section used as a source form for a dynamic grid section, you must apply the same in-place revision to the dynamic grid section.

When you design control captions that will be used in a dynamic grid (for example, for an item question or codelist label), make sure that they are fully labeled so that the data makes sense in the dynamic grid.