Conducting Medical Device Clinical Trials in the EU
Published by
PJB Publications Ltd.
Published
2007/06
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PJB52505
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Table of Contents
CHAPTER 1 INTRODUCTION
1.1 The medical device directives
1.1.1 Proposed changes specific to clinical trials
1.1.2 European Directive 2001/20/EEC
1.2 Guidelines
1.2.1 I SO 14155 parts 1 and 2
1.3 Trials of CE-marked devices
CHAPTER 2 APPROVAL ROUTES AND CONSIDERATIONS
2.1 Classification
2.2 Risk analysis
2.3 Routes to approval
CHAPTER 3 PLANNING
3.1 The budg et
3.1.1 Direct costs
3.1.1.1 Manufacturing costs
3.1.1.2 Pre-investigation development costs
3.1.1.3 Clinical trial budget
...Personnel costs
...Patient-related costs
...Miscellaneous costs
3.1.2 I ndirect costs
3.2 Selection of the clinical investigation team
3.2.1 Legal roles
3.2.1.1 The sponsor
3.2.1.2 The monitor
3.2.1.3 The investigator
3.2.2 Other roles
3.3 Study design
3.4 Clinical investigational plan
CHAPTER 4 PREPARATION
4.1 Documentation
4.1.1 The clinical trial agreement (CTA)
4.1.2 Clinical trial master agreements
4.1.3 Investigator' s Brochure (IB)
4.1.4 Ethics committee approval
4.1.5 Patients' Informed consent (PIC)
4.1.6 Adverse event form
4.1.7 Subject screening log
4.1.8 Subject identification code list
4.1.9 Subject enrolment log
4.1.10 Initials/sig natures list
4.1.11 Case report forms (CRFs)
4.1.12 Clinical study report (CSR)
4.1.13 Other documents
4.2 Labelling and instructions for use
4.3 Insurance
4.4 Site selection
...PI qualifications
...Potential subject population
...Adequate staff & resources - provide CVs, business cards, org
anizational chart
...Availability of appropriate facilities & equipment
...EC services & turn around
...Good clinical practice knowledge & compliance document any formal GCP
training
...Responsiveness of site and rapidity of study initiation
4.4.1 I taly
4.5 Monitor selection
4.6 Training
CHAPTER 5 IMPLEMENTATION
5.1 Resource allocation
5.2 Subject recruitment
5.2.1 Screening
5.2.2 Retention
5.3 Monitoring
CHAPTER 6 CLOSING
6.1 Notification
6.2 Collection and filing
6.2.1 Data management
6.2.1.1 Data protection
6.2.2 Risk management file
6.3 Analysis
6.4 The clinical study report
CHAPTER 7 ISSUES
7.1 US and European comparisons
7.1.1 Good clinical practice
7.1.2 Adverse events
7.1.3 Reporting and publishing
7.1.4 Classification
7.2 Conformity assessment
7.2.1 Classification
7.2.2 Notified bodies
7.2.3 Conformity assessment
7.3 Advanced therapies legislation
7.4 Clinical Evaluation Task Force
7.5 Data protection
7.6 Branding
CHAPTER 8 COUNTRY SPECIFICS
8.1 Austria
8.1.1 Competent Authority
8.1.2 Notified bodies
8.1.3 Translation
8.1.4 Notification requirements
8.1.5 Insurance
8.1.6 Other issues
8.2 Belg ium
8.2.1 Competent Authority
8.2.2 Notified bodies
8.2.3 Translation
8.2.4 Notification requirements
8.2.5 Insurance
8.2.6 Other issues
8.3 Denmark
8.3.1 Competent Authority
8.3.2 Notified bodies
8.3.3 Translation
8.3.4 Notification requirements
8.3.5 Insurance
8.3.6 Other issues
8.4 Finland
8.4.1 Competent Authority
8.4.2 Notified bodies
8.4.3 Translation
8.4.4 Notification requirements
8.4.5 Insurance
8.4.6 Other issues
8.5 France
8.5.1 Competent Authority
8.5.2 Notified bodies
8.5.3 Translation
8.5.4 Notification requirements
8.5.5 Insurance
8.5.6 Other issues
8.6 Germ any
8.6.1 Competent Authority
8.6.2 Notified bodies
8.6.3 Translation
8.6.4 Notification requirements
8.6.5 Insurance
8.6.6 Other issues
8.7 Ireland
8.7.1 Competent Authority
8.7.2 Notified bodies
8.7.3 Translation
8.7.4 Notification requirements
8.7.5 Insurance
8.7.6 Other issues
8.8 Italy
8.8.1 Competent Authority
8.8.2 Notified bodies
8.8.3 Translation
8.8.4 Notification requirements
8.8.5 Insurance
8.8.6 Other issues
8.9 The Netherlands
8.9.1 Competent Authority
8.9.2 Notified bodies
8.9.3 Translation
8.9.4 Notification requirements
8.9.5 Insurance
8.9.6 Other issues
8.10 Norway
8.10.1 Competent Authority
8.10.2 Notified bodies
8.10.3 Translation
8.10.4 Notification requirements
8.10.5 Insurance
8.10.6 Other issues
8.11 Spain
8.11.1 Competent Authority
8.11.2 Notified bodies
8.11.3 Translation
8.11.4 Notification requirements
8.11.5 Insurance
8.11.6 Other issues
8.12 Switzerland
8.12.1 Competent Authority
8.12.2 Notified bodies
8.12.3 Translation
8.12.4 Notification requirements
8.12.5 Insurance
8.12.6 Other issues
8.13 The UK
8.13.1 Competent Authority
8.13.2 Notified bodies
8.13.3 Translation
8.13.4 Notification requirements
8.13.5 Insurance
8.13.6 Other issues
CHAPTER 9 SECTOR INFORMATION
9.1 Class
9.1.1 Class I
9.1.2 Class IIa
9.1.3 Class IIb
9.1.4 Active Im lantable Medical Devices
9.2 Medical devices compared to pharm aceuticals
9.2.1 Timelines
9.2.1.1 Study size
9.2.1.2 Approval process
CHAPTER 10 CASE STUDIES
10.1 Drug device combination product
10.2 Sample size
10.3 Site selection
10.4 Storage
10.5 Device accountability
10.6 Classification
APPENDIX
LIST OF TABLES
Table 2.1 Risk matrix
Table 2.2 Risk management
Table 2.3 A hierarchy of evidence
Table 3.1 Processes conducted in the planning phase
Table 3.2 Processes and costing for an investigator with a 12 patient
investigation
Table 4.1 Processes conducted in the preparatory phase
Table 5.1 Processes conducted in the im plementation phase
Table 5.2 Documentation and location
Table 5.3 Clinical investigation properties
Table 5.4 The funnel effect in subject recruitment
Table 6.1 Processes conducted in the closing phase
Table 6.2 Documentation and location at closure of investigation
Table 7.1 European and US GCP requirements
Table 7.2 Comparative classification rules in the EU and the US
Table 7.3 Examples of Medical Devices Classified Using Annex I X of the
European Medical Device Directive (EC/93/42) and the US system
Table 7.4 Impact of phonetic sounds
Table 8.1 Documents/information for initial submission in Austria
Table 8.2 Documents/information for initial submission in Belgium
Table 8.3 Documents/information for initial submission in Finland
Table 8.4 Documents/information for initial submission in Germany
Table 8.5 Documents/information for initial submission in Ireland
Table 8.6 Documents/information for initial submission in Italy
Table 8.7 Documents/information for initial submission in The Netherlands
Table 8.8 Documents/information for initial submission in Spain
Table 8.9 Documents/information for initial submission in the UK
Table 9.1 The medical device and pharm aceutical sectors
Table 9.2 EC approval issues in European Countries for m edical devices
Table 9.3 CA approval issues in European Countries for m edical devices
Table 9.4 Regulatory and ethical review time in European countries for
pharmaceuticals and medical devices
LIST OF FIGURES
Figure 2.1 Classification process for multi-part wound drainage device
Figure 2.2 Flow chart of procedures and guidance documents involved in
initiating a clinical trial
Figure 3.1 Requirements and processes leading to planning phase of a
clinical investigation
Figure 5.1 Example of a subject questionnaire for the clinical
investigation of a continuous glucose sensor in the management of Type 1
diabetes in adults
Figure 7.1 Adverse events reporting requirements in the US
Figure 7.2 Adverse events reporting requirements in Europe
Figure 7.3 Brand logo of NWTHA asthma audit
Figure 9.1 Approval route for Class I devices
Figure 9.2 Approval route for Class IIa devices
Figure 9.3 Approval route for Class IIb devices
Figure 9.4 Approval route for Class III devices
Figure 9.5 The phases of a clinical investigation for a medical device
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