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.

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:

  1. Open the Inbox Item and select Edit.
  2. In the Case Validity and Source section, in the Special Report Classification field select an option from the picklist.
  3. 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:

  1. Open the Case and select Edit.
  2. In the Details section, in the Special Report Classification field select an option from the picklist.
  3. 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.

Read More

Learn more about reporting to the PMDA.