Prepare and apply for clinical study

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	23.02.2014 09:04:47
Modified:	27.02.2018 10:52:38

Diagram Elements :

Prepare and apply for clinical study

DIMDI

Implement data monitoring committee

RM Representative

Evaluate potential safety risks

Implement monitor

Monitor

Ethics Comission

Determine actual benefit risk consideration

Device Hazard Analysis (DHA)

CEF - Clinical Evaluation File

Substantiate need to perform the clinical study

EN ISO 14155-2

EN ISO 14155-1

Create ethic commission votum application file

Attempt for clinical study abandoned

Clinical study approved

Clinical investigator

Patient consent form

CRF - Case Report Form

Qualification investigation site

Qualification clinical investigator

Contract sponsor - principal investigator

Contract sponsor - monitor

CIP (Clinical investigation plan)

Ethic commission votum for clinical study

Patient insurance

Sponsor

Product Manager

Preparation for execution of clinical study finished

Apply for clinicial study

High safety risks concerning the product?

Create clinical investigation plan (CIP)

Clinical study accepted by ethics commission?

Get ethic commission votum

Create patient consense form

Create CRF

Define and proof of evidence of clincial investigator qualification and clinical investigation site

Provide contract between sponsor and principal investigator

Provide contract between sponsor and monitor

Provide patient insurance

Clinical study design

Define primary and secondary clinical endpoints

CAB Clinical Advisory Board

Manager CAM

CA Specialist

Define study design

Generate new clinical data