Perform clinical study based on CIP

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	20.05.2014 14:22:50
Modified:	27.02.2018 10:52:38

Diagram Elements :

Perform clinical study based on CIP

Prototype

CRF - Case Report Form

CIP (Clinical investigation plan)

Study on hold info

Clinical acdtivity ended

Premature clinical study abortion on purpose

Inform Clinical investigator

NCA - National Competent Authorities

Clinical investigator

CA Specialist

Safety representative

Monitor

Re-envoke study

Continue study?

Immediate measures and decisions

Set study on hold

Medical Device Reporting (MDR) to NCAs

Occurance of AE / SAE

Follow CIP

Clinical study activity