Full Title Clinical Evaluation Reporting

Short Title Clinical Evaluation Reporting

Code REGU09005
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

Description
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 when a clinical investigation is necessary and the regulatory processes involved in such an evaluation.

Indicative Syllabus
The following is a summary of the main topics included in this particular module: Clinical terms; clinical evaluation requirements in accordance with MED DEV 2.7.1 and GHTF Guidance Documents; regulatory submissions including Clinical Trial Application; risk management; link with reimbursement and health technology assessment (HTA), role of human factors, relevant standards including ISO 14155.

Identify the interaction between risk analysis and clinical evaluation.

Demonstrate they have detailed knowledge and understanding of clinical trials application process and reimbursement.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate they have detailed knowledge and understanding of the key clinical terms, types of studies, key clinical requirements and associated standards.

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

  3. Critique the role of human factors studies and the impact of risk assessment.

  4. Demonstrate an ability to prepare documentation associated with clinical evaluations.

  5. Illustrate an ability to prepare regulatory submissions and clinical trial applications.

  6. Formulate and communicate a competency in how to complete a full clinical evaluation plan, which will include objectives, methodology and literature searching processes and resulting clinical evaluation report including format, contents and layout

  7. Prepare a clinical evaluation report.

  8. 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).


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

Assessment Facilitites
Moodle access

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 6,7,8 60 Week 7
Case Study workshop scenarios (formative) 4,5 20 Week 12
LAQ 1,2,3 20 Week 4


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources
  • Clinical research and regulatory affairs: http://informahealthcare.com/loi/crr

Other Resources
None
Url Resources
Additional Info

ISBN BookList

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