Vault supports the following Special Report Classifications during Inbox Item intake and Case processing for reporting to the PMDA:
- 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 classifications can be found through the PMDA website.
Optionally, contact Veeva Managed Services to have additional options created for this field. This is useful in situations, such as Special Report Classifications for Japan, when Cases should be reported to certain destinations only.
Apply Special Report Classifications
To identify an Inbox Item or Case as a Safety Measure Report or a Research Report, use the following procedures:
- Intake: To identify the special classification during intake, populate the Special Report Classification field on the Inbox Item. When you promote the Inbox Item, the selected Special Report Classification value appears on the Case.
- Case Processing: To identify the special classification during case processing, populate or update the Special Report Classification field on the Case.
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.