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Patient Support Program Source Data Quality Check in P360 Author:…
Patient Support Program
Source Data Quality Check in P360
Author: Charlie Chen
Last Updated: 5 Jan 2021
P360 Data Structure
Reporting Functionality
Customized per Affiliate
Data Elements with PV Risks
Requirements
SOP-0102065 Global: MAP Pharmacovigilance Compliance
SRD-0114019 Global: MAP SDQC Guidance and Form
Definition of Source Data
Metrics
SDQC Completed On Time
100% Review Completed On Time
SDQC with Missed AEs
Preparatory work
P360 Data Cleanup
Document without MAP ID
Activity without MAP ID
Case without Roche Case Number
Other Data Quality Checks
gSheet: P360 Data Quality Check for PSPs
gSheet: Data Exported from P360
Identification of Source Data
Email
Vendor's Email (Program Specific)
Vendor's Email (TA Specific)
Line Chat Bot
eFax (Electronic Document)
Vendor's CRM
Fax (Paper Document)
Excel
Postal (Paper Document)
P360
Program Cases
Activities (Task and Log a Call)
Documents
Audio Recording / Voice Messaging
Communication of SDQC Frequency and Timelines
gSheet: PSP Oversight and SDQC Tasks (for Vendors)
gSheet: MAP and Vendor Oversight (for Roche)
Notification Email after PV Approval
Review of AE Reported in the SDQC Period
gSheet: Local Safety Event Log
Documentation
Google Doc: MAP Systems and Summary of SDQC Activities
SRD-0114019 Global: MAP SDQC Guidance and Form
GoMAP
Follow-up Items (in gSheet: Backlog & Meeting Minutes)
CAPA
gSheet: Roche's AE Reporting Q&A
Roche Product Vigilance Refresher Training
gSheet: Summary of Findings from Affiliate Core Metrics
gSheet: Issue Log (part of SPOP)