REGU08010 2020 Fundamentals of Medical Device Clinical Trials
Full Title
Fundamentals of Medical Device Clinical Trials
Transcript Title
Fundamentals of Medical Device
Code
REGU08010
Attendance
N/A %
Subject Area
REGU - 0421 Regulatory Affairs
Department
LIFE - Life Sciences
Level
08 - Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDO_E08 202000 Certificate in Science in Medical Device Regulatory Affairs and Operations
SG_SMEDO_E08 202100 Certificate in Medical Device Regulatory Affairs and Operations
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality
Description
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;
1.
Outline and evaluate the reason for current regulations regarding the conduct of clinical trials
2.
Recognise and describe the FDA IDE regulations and the ISO14155 requirements
3.
Debate the key roles of individuals involved in clinical research and Describe the key elements of clinical trial design and ICH GCP
4.
Evaluate the key types of clinical trials and Describe the key elements of clinical trial design and ICH GCP
5.
Relate Ethical principles and human subject protection and Informed Consent requirements
6.
Appraise 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 in line with Marks and standards and the qulaity manual.
Indicative Syllabus
This particular module covers the main historical events that led to increased regulation of the development of medical devices, it evaluates the Product development process including Ethical principles and human subject protection. The module reviews Guidelines and regulations governing clinical research, including FDA IDE regulations, ICH GCP and ISO 14155. The module also assesses 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 are covered. An overview of the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact is provided and a look at 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 | Coursework Assessment | Written Report/Essay | 50 % | Week 11 | 4,6 |
| 2 | MCQ/LAQ | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 6 | 1,2,3,4,5,6 |
| 3 | Workshop evaluation | Coursework 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
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
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