REGU08010 2017 Fundamentals of Medical Device Clinical Trials

General Details

Full Title
Fundamentals of Medical Device Clinical Trials
Transcript Title
Med Dev Clinical Trials
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality

This module aims to provide students with an introduction to and a fundamental understanding of how clinical trials are designed to address questions regarding the safety and effectiveness of medical devices. This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between the regulators and sponsors.

Learning Outcomes

On completion of this module the learner will/should be able to;


Explain the reason for current regulations regarding the conduct of clinical trials


Confirm and explain understanding of FDA IDE regulations


Relate understanding of ISO 14155 requirements


Summarise the key roles of individuals involved in clinical research


Identify the key types of clinical trials


Describe the key elements of clinical trial design and ICH GCP


Relate Ethical principles and human subject protection and Informed Consent requirements


Explain the impact of MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and some of the most significant changes

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module:

  • Main historical events that led to increased regulation of the development of medical devices
  • Product development process
  • Ethical principles and human subject protection
  • Guidelines and regulations governing clinical research, including FDA IDE regulations, ICH GCP and ISO 14155
  • Key stakeholders and roles, responsibilities and contributions of clinical research professionals in the process of conducting clinical trial
  • Types and designs of clinical studies
  • Preclinical requirements
  • Protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations;
  • Informed consent
  • Overview of the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact
  • Clinical evaluation and when to do a study
  • Clinical trial supplies and labelling
  • Post market surveillance studies
  • Health economics and device trials

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Technical report Continuous Assessment Written Report 50 % Week 11 4,5,6,7,8
2 MCQ/LAQ Continuous Assessment Multiple Choice 20 % Week 6 1,2,3,4,5,6,7
3 Workshop evaluation Continuous Assessment Practical Evaluation 30 % Week 9 3,6

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2007-11-05 Clinical Evaluation of Medical Devices Humana Press

The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Recommended Reading
2011-05-12 The Design and Management of Medical Device Clinical Trials: Strategies and Challenges Wiley

Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.

Module Resources

Non ISBN Literary Resources

as per booklist