Adverse Event Data Management

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Mind Map overview of AE data management.

Business

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

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Adverse Event Data Management

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

Adverse Event Data Management

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