BMS PV Integration

Internal Training : HL Conceptual Data Model

Author:
Rohini Patil,
Senior Business Analyst

BMS PV Integration
Safety Case Data: HL Conceptual Data Model*
Case Type

Case

Case Category

Project Id

Study

Protocol

Study Type

Reporter

HCP
Non-HCP

Parent

Patient

Lab Data

Pregnancy
Disease
Product Type
(Suspect/Concomitant)
Product Coding

Ingredients
Product

Dosing
Seriousness Criteria

Event Information
Event

Event Coding

Symptoms/Diagnosis

Country of Case

Country

Related/ Non-Related

Event Assessment

Country of
Drug/Product
Approval
Causality
Expectedness

Seriousness Severity
* Will be further worked on in the Analysis Phase

Thank-you