12 Other Considerations
For submitting a Malfunction Only (No AE) report to CBER, these are the data entry recommendations:
- Patient tab:
- No data required to be entered in the Patient Information, Patient Details, Race Information, Other Relevant History sections. Export mappings populates most of the Patient elements as None, as per regulations.
- Click on the Patient Notes icon in the Patient Information section, either enter the text None in the text area or select any Null flavor using the NF button.
- Product Tab: Set the Malfunction field to Yes and select one or more Device Problem codes in the Device tab of the Constituent Device Product.
- Event tab:
- Enter No Adverse Event as Reported term to get the properly coded corresponding MedDRA term.
- Set Null Flavor NASK for the following fields:
- Onset date/time
- Stop date/time
- Outcome of Event: Unknown
- Analysis tab:
- Case Serious is set to No.