About the Feature
With the 21R1 release, Vault Safety introduced the option to display adverse events using the MedDRA Preferred Term (PT) on CIOMS I and MedWatch 3500A forms. The feature was originally introduced with Support-enablement. In 23R3, the feature is enabled through an Admin Checkbox.
Once enabled, all new CIOMS I and MedWatch 3500A forms will use the MedDRA PT for adverse events. This will not impact previously generated reports, which must be re-generated to take effect.
Note If Veeva Support previously enabled this feature in your Vault, you do not need to take any action. In your Vault’s Submission and Distribution Settings, the Use Adverse Event PT on CIOMS and MedWatch 3500A checkbox is automatically selected.
For more information on these reports, see CIOMS I Generation Data Mapping and FDA 3500A Generation Data Mapping.
Turn On Use Adverse Event PT on CIOMS and MedWatch 3500A
Complete the following steps to turn on this feature in your Vault:
- Go to Admin > Settings > Submission and Distribution Settings.
- Select Edit.
- Select the Use Adverse Event PT on CIOMS and MedWatch 3500A checkbox.
- Select Save.
