Manage clinical study

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	19.05.2014 11:12:54
Modified:	27.02.2018 10:52:33

Diagram Elements :

Manage clinical study

Prototype

Label USE FOR CLINICAL STUDY ONLY

Investigation site initiation

QA Specialist

CA Specialist

Deviations closed by Clinical Investigator

Generate list of deviations and constraints

Study in compliance with CIP ?

Perform regular monitoring audit

Create constraints

Audit passed?

Perform clinical study site audit

Clinical investigator brochure

EN ISO 14155-1

Create clinical investigator brochure

NCA - National Competent Authorities

Final report clinical study design

CIP (Clinical investigation plan)

Inform NCA about ending of clinical study

Sponsor

Clinical investigator

Monitor

Product Manager

Clinical study finshed

Update monitoring report

Create final report

Regular monitoring

Perform clinical study based on CIP

Introduce clinical staff

Identify medical device for use in a clinical study only

Authorization for clincical study achieved