REGU09005 2019 Clinical Evaluation Reporting

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

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.

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

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.

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.