REGU09005 2019 Clinical Evaluation Reporting

General Details

Full Title
Clinical Evaluation Reporting
Transcript Title
Clinical Evaluation Reporting
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
09 - NFQ Level 9
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_M09 201900 Master of Science in Science in Medical Technology Regulatory Affairs SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Science in Medical TechnologyRegulatory Affairs SG_SMEDI_E09 201900 Certificate in Science in Medical Technology Regulatory Affairs

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of how to source, filter and critically appraise relevant clinical literature and to evaluate when a clinical investigation is necessary and the regulatory processes involved in such an evaluation.

Learning Outcomes

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


Demonstrate they have detailed knowledge and understanding of the key clinical terms, types of studies, key clinical requirements and associated standards.


Source and interpret, regulations, standards and guidances on how clinical requirements in chosen markets are achieved


Demonstrate ability to examine a Device's intended Use and develop appropriate Research Question to be evaluated in the context of clinical literature review 


 Demonstrate an ability to source and critically appraise clinical literature and subsequently prepare documentation associated with clinical evaluations and clinical trial applications (as part of a regulatory submissions) 


Evaluate and assess a medical device to determine what, if any, clinical studies are required based upon a critical review of existing data for comparable medical devices (consider strategy development, trial design and clinical evaluation context) and prepare a CER

Teaching and Learning Strategies

The educational elements will be provided by the Institute of Technology Sligo and  NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

Module Assessment Strategies

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

Repeat Assessments

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

Module Dependencies

REGU09003 201900 Technical Report Writing

Indicative Syllabus

The following is a summary of the main topics included in this particular module: Key clinical terms and definitions in relation to clinical investigations; Clinical Literature Review and Clinical Literature Appraisal as per Evidence based research methodologies (e.g. PICO), clinical evaluation requirements in accordance with MED DEV 2.7.1 and GHTF Guidance Documents;  Clinical Investiagation Requirements as per ISO 14155; Regulatory submissions including Clinical Trial Applications; Intergration of risk management considerations into clinical evaluations and clinical investigations;.   
Identify the interaction between risk analysis and clinical evaluation. 

Demonstrate they have detailed knowledge and understanding of clinical  evaluation requirements and clinical trials application process in Europe and the US.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment written assignment Continuous Assessment Assignment 40 % Week 7 3,4
2 Assessment Continuous Assessment Assessment 20 % Week 4 1,2
3 Assignment and viva Continuous Assessment Assignment 40 % Week 4 3,4,5

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2013-07-02 Designing Clinical Research LWW
ISBN 1608318044 ISBN-13 9781608318049

Designing Clinical Research has been extensively revised and continues to set the standard as a practical guide for doctors, nurses, pharmacists, and other health professionals involved in all forms of clinical, translational, and public health research. It presents advanced epidemiologic concepts in a reader-friendly way, and suggests common sense approaches to the challenging judgments involved in designing, funding, and implementing.

New to this edition:

  • Expanded and updated content in every chapter, with new material on: non-inferiority trials for comparative effectiveness research incidence-density case-control studies confounding and effect modification diagnostic test studies to inform prediction rules ethical aspects of whole genome sequencing automated data management approaches new NIH grant-writing requirements
  • Color format, and Electronic access, powered by Inkling as a free companion to the text viewable through your browser or as a download to tablet or smartphone the complete text with optimized navigation note-sharing, highlighting and bookmarking capability cross-linking of references and content rapid search options linked to the new glossary

Recommended Reading
2005-09-13 Clinical Epidemiology: How to Do Clinical Practice Research (CLINICAL EPIDEMIOLOGY (SACKETT)) LWW
ISBN 0781745241 ISBN-13 9780781745246

The Third Edition of this popular text focuses on clinical-practice research methods. It is written by clinicians with experience in generating and answering researchable questions about real-world clinical practice and health carethe prevention, treatment, diagnosis, prognosis, and causes of diseases, the measurement of quality of life, and the effects of innovations in health services. The book has a problem-oriented and protocol-based approach and is written at an introductory level, emphasizing key principles and their applications.

A bound-in CD-ROM contains the full text of the book to help the reader locate needed information.

Module Resources

Non ISBN Literary Resources
Journal Resources
Book Cover Book Details
Dr. Stephen B Hulley MD MPH 2013 Designing Clinical Research LWW
ISBN-10 1608318044 ISBN-13 9781608318049
R. Brian Haynes 2005 Clinical Epidemiology: How to Do Clinical Practice Research (CLINICAL EPIDEMIOLOGY (SACKETT)) LWW
ISBN-10 0781745241 ISBN-13 9780781745246
URL Resources
Book Cover Book Details
Dr. Stephen B Hulley MD MPH 2013 Designing Clinical Research LWW
ISBN-10 1608318044 ISBN-13 9781608318049
R. Brian Haynes 2005 Clinical Epidemiology: How to Do Clinical Practice Research (CLINICAL EPIDEMIOLOGY (SACKETT)) LWW
ISBN-10 0781745241 ISBN-13 9780781745246
Other Resources


Additional Information