This document discusses guidelines and regulations for clinical trials and adverse event reporting from various international organizations such as the International Committee on Harmonisation (ICH), FDA, and EMA. It outlines the actors and roles involved in the processes of case registration, data entry, assessment, quality control, and reporting of data from clinical trials, physicians, and the general public on adverse events related to medical products and devices. The diagram also shows the various formats, timelines, sources, and classifications used to manage this post-marketing safety data.

1. Volume 9a
Clinical Trial Directives EMA
FDA Guidance Regulations
FDA
International Committee Harmonisation (ICH)
Active Ingredients
Medicinal Excepients
Physicians/Healthcare Product
General Public Medical Device
Reporters
Affiliates Organisations
Case Registration Reporters
Follow-up and Data Entry
Data Entry Clinical Trials
Sources
Medical Assessor Actors Reported Literature
Quality Control/Assurance
Unique
FDA
Report Type Duplicate
EMA
Reported Term
Japan Competent Authorities
Others Adverse Event Adverse Events Classified By
Reporter
Qualified Person PV
Data Management Medical Assessor
© Anil Dhiri, 2010
Serious Unexpected
Devices AE Triage Classification Serious
Expected
CIOMS II
CIOMS I Subtype Pregnancy
MedWatch Types Coding
Narratives
DSUR (ASR)
Concomitant Medication
PSUR
Coding
Data Entry (3D)
Six
Assessment (2D) Reports monthly
7 day Update
Quality Assurance (4D)
Report Data Dictionaries MedDRA
Approve & Distribute(1D) Timelines & Rules
Annual Update
Approve & Distribute (7D) 15 Day WhoDD
EV Web Entry? PDF
Paper
E2B (ICH Formats
Format)
PV Data Management.mmap - 10/06/2010 - Mindjet