Design questions to be integrated to Safety

Configure your questions so that adverse event data is included in a safety case. You can mark some questions as mandatory, meaning that Safety does not receive the safety case event until a site user answers all required questions.

You should know that E2B(R3) mapping is supported for read-only, data classified, and calculated fields.

You should also know that the Mandatory for Case Creation toggle is only available for fields required by Safety.

In the context of Advanced Study Versioning (ASV), should an E2B(R3) data element mapping change, safety cases that were previously integrated with Safety are not updated. For example, if a question mapped to G.k.7.r.1 - Indication as Reported by the Primary Source is remapped to G.k.7.r.2a - MedDRA Version for Indication, this change is only reflected in safety cases integrated after the change is made. For a detailed list of all E2B(R3) elements, see E2B(R3) dictionary, and for more information about ASV, see About Advanced Study Versioning (ASV).

  1. Open the draft version of your study. For more information, see Open a study's design.
  2. In the Forms tab, create a new form or open an existing one.
  3. Expand the Details side panel, then enable the Include in Safety Case toggle.
  4. Select Add to add a new question. You can also work on an existing question.
  5. Map the question to the E2B(R3) standard by performing the following:
    1. Expand the Advanced side panel.
    2. From the E2B R3 drop-down, select a specific value from the appropriate category. For more information on the available data mappings, see E2B(R3) dictionary.
  6. Depending on your needs, you can also enable Mandatory for Case Creation, from the Advanced side panel.

    Note:

    the safety case is only created if all mandatory items have been completed.
  7. Optionally, you can configure your question to trigger a follow-up case.
  8. Select Save or Save and Close.

Parent topic: Question types and settings