Enter data for an adverse event

To continuously collect a subject's data on adverse events, and possibly concomitant medication, hospitalizations, and many more, then depending on how your study has been designed you can access and complete the forms within the Adverse Events visit, at any time during the course of the study.

For more information on how to handle reference information during the process of collecting data, as well as tips and tricks on how to answer certain question types, see Best practices for collecting data.

Want to see how to perform this task? Watch the video below.

Caution:

The completion of a hidden, required question is taken into account to determine a visit's status, but it won't be taken into account to determine a form's status. To learn more about how a visit's status and a form's status is recorded, see How does a hidden and required question impact a form and visit's status?.

Note:

Consider the following:
  • If you enter data that doesn't meet the requirements specified by the sponsor in the form fields, a message explains why the answer does not meet the required criteria. If the question is marked as required, you can't randomize or dispense until it is answered. If the question isn't marked as required, you can randomize or dispense without answering.
  • If the form you want to delete contains an open query, you must close the query.
  1. On the Home page, determine where to work. For more information, see Access study modes and pages.
  2. Along the top, make sure Subjects is selected.
  3. In the table, locate the subject, and click the first column, right after the Subject ID.
    This column is created specifically for collecting data on adverse events, concomitant medications, hospitalizations, and many more. Typically, this column might be called "Adverse Event" or "ConMed".
  4. Enter data in a form:
    • If you are entering data in a regular form, follow the usual steps for completing a form.
    • If you are entering the first instance of data in the repeating form, click any cell in the first row to enter data directly into the table.
    • If you already entered data in the repeating form and want to add a new instance, in the upper-left corner of the form section, click the Add button and then click each cell in the row to add data.
  5. To edit or modify data in a repeating form, click the table cell that you want to edit.
  6. To delete data in a repeating form, click the Delete icon (Delete icon) on the left of the table row.
  7. Once you added data in the repeating form, in the lower right of the form click Save or Save & Close.

    Tip:

    You can also save the repeating form by clicking outside the table.
Depending on a form's status, you may see one of the following status icons on the Forms sidebar:
  • When complete, a form displays a Complete icon Complete form icon.
  • When a required question is not answered, a form displays an Incomplete icon Incomplete form icon.
  • When a required question contains a validation error, a form displays a Validation error icon Form contains error icon.

Want to learn more about the possible statuses of a form? See Form status icon descriptions in the Icon Reference guide.

Related Topics

Parent topic: Enter data and dispense kits