Learn how to update your Vault’s configuration to enable conditional expectedness.
About Conditional Expectedness
The conditional expectedness feature introduces the ability for admins to specify seriousness criteria conditions when configuring Datasheets, which define when a listed term is unexpected.
Seriousness criteria can be configured at both the Datasheet and MedDRA Criteria (listed term) level.
Admins can also configure precise expectedness on Datasheets, which prevents the system from marking terms as unexpected if they are not listed on the Datasheet. Additionally, a new Expectedness MedDRA Criteria setting allows you to specify unexpected terms on a Datasheet.
Once this feature is enabled, to learn more about conditional expectedness, see Manage Datasheets and Auto-Expectedness.
Update Datasheets Layout
- Go to Configuration > Objects > Datasheet > Layouts.
- Open the Datasheet Detail Page Layout for editing.
- Insert a “Datasheet Defaults” section:
- Type: Detail Form
- Layout: One Column
- Placement: (Recommended) Place the section directly under “Details”.
- Fields:
- Unexpected Seriousness Criteria (unexpected_seriousness_criteria__v)
- Enable Precise Expectedness (enable_precise_expectedness__v)
- Add the following columns to the “Expected Adverse Events” related object section:
- Expectedness (Place after Medical Condition)
- Seriousness Exclusion (Place after Expectedness)
Update MedDRA Criteria Layout
- Go to Configuration > Objects > MedDRA Criteria > Layouts.
- Create a layout for Datasheet Criteria with the following settings:
- Object Type: Datasheet Criteria
- Layout Label: Datasheet Criteria Detail Page Layout
- Edit the “Details” section to include the following fields in order:
- Organization
- Datasheet
- MedDRA Criteria
- Include Lower Levels
- MedDRA Condition
- Expectedness
- Seriousness Exclusion
- Active Date Start
- Active Date End
- Description