Learn about Vault Safety features that support processing Cases with Special Report Classifications and reporting to the PMDA.
About Special Report Classification Intake and Processing
Vault Safety supports the following Special Report Classifications during Inbox Item intake and Case processing:
| Special Report Classification | Description |
|---|---|
| Safety Measures Report | Includes the discontinuation of production from the viewpoint of efficacy or safety in a foreign country, as well as changes in indications or effects, dosage or administration, or manufacturing methods, and the distribution of doctor's letters or similar important "precautions for use" revisions. |
| Research Reports | Supports the PMDA in collecting research reports published in the academic journals of Japan or foreign countries or the studies conducted internally or by relevant companies. |
More information on these Special Report Classifications can be found through the PMDA website.
Note: This feature is available for intake using Inbox Items only. This feature is not available for AER intake.
Apply Special Report Classifications
To identify an Inbox Item or Case as a Safety Measure Report or a Research Report, use the following procedures.
Add Special Reporting Classifications During Intake
To identify the Special Report Classification of an Inbox Item, perform the following steps:
- Open the Inbox Item and select Edit.
- In the Case Validity and Source section, in the Special Report Classification field select an option from the picklist.
- Select Save.
Result
When you promote the Inbox Item, the selected Special Report Classification value appears on the Case in the Details section.
Add Special Reporting Classifications During Case Processing
To identify the Special Report Classification of a Case, perform the following steps:
- Open the Case and select Edit.
- In the Details section, in the Special Report Classification field select an option from the picklist.
- Select Save.
Reporting Rules Evaluation for Special Reports
When the reporting rules engine runs on a Case with a value in the Special Report Classification field, the Case details are compared against the following PMDA rules:
| Rule | Special Report Classification |
|---|---|
| INV - 15day - Research/Safety Measure | Research Report, Safety Measure |
| PMK - 15day - Safety Measure | Safety Measure |
| PMK - 30day - Research | Research Report |
Review the PMDA ICSR Reporting Rule Set version 3.0 for more details on the reporting rule parameters and Transmission generation.
Note: When the Special Report Classification rule parameter is set to No, the rule is evaluated when the Special Report Classification field is blank. When evaluating reporting rules, Cases with Special Report Classification values are always excluded unless the Special Report Classification rule parameter is specified in the Safety Rule Set.
Read More
Learn more about reporting to the PMDA.