Module title: Regulations in Clinical Research

SCQF level: 09:
SCQF credit value: 20.00
ECTS credit value: 10

Module code: NMS09705
Module leader: Gordon Hill
School School of Health & Social Care
Subject area group: Centre for Health and Wellbeing
Prerequisites

There are no pre-requisites for this module to be added

2017/8, Trimester 3, Blended, Edinburgh Napier University
Occurrence: 001
Primary mode of delivery: Blended
Location of delivery: SINGAPORE
Partner: Edinburgh Napier University
Member of staff responsible for delivering module: Gordon Hill
Module Organiser:


Learning, Teaching and Assessment (LTA) Approach:
Learning & teaching methods including their alignment to LOs
This module will be delivered online via Moodle and Elluminate Live tutorials. Collaborative learning will be promoted through the use of Elluminate Live sessions facilitated by a lecturer to assure the students the experience to meet learning outcomes 1, 2, 3 and 4.
Moodle units offered to support students will provide students with additional material to achieve LO4. Asynchronous discussions with peers and the lecturer will support and facilitate learning whilst the end of unit activities will promote active engagement in learning and will ensure that students continue to achieve LO 3 throughout the module. The use of Moodle gives greater flexibility so students can choose to learn at a time which suits their work pattern. Elluminate sessions offer the opportunity to communicate with fellow students in small groups to learn through interactive teaching sessions which aim to build on the content of Moodle. The content of Moodle, Elluminate tutorials and submission of a final assignment contribute towards meeting LOs 1-4.
Embedding of employability/ PDP/ scholarship skills
This module contributes to the student’s personal development plan by enhancing their knowledge and skills in applying the evidence that underpins the regulations and legislation pertaing to clinical research. Students will also evaluate its appropriateness for implementation into practice. Completion of this module will enhance the student’s ability to undertake their role
Assessment
Summative assessment:
2,000 word report on the process for approval of a clinical trial. This would include production of a flowchart that could be used in the student’s local area (LO4)
3,000 word essay to demonstrate an understanding of the relationship between regulations and clinical research practice (LOs 1-3)
Learning is encouraged in a number of ways, including by the submission of formative work during the module, inlcuding online a

Formative Assessment:
The University is currently undertaking work to improve the quality of information provided on methods of assessment and feedback. Please refer to the section on Learning and Teaching Approaches above for further information about this module’s learning, teaching and assessment practices, including formative and summative approaches.

Summative Assessment:
The University is currently undertaking work to improve the quality of information provided on methods of assessment and feedback. Please refer to the section on Learning and Teaching Approaches above for further information about this module’s learning, teaching and assessment practices, including formative and summative approaches.

Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Online Lecture 5
Online Guided independent study 100
Independent Learning Guided independent study 95
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Report 40 4 10 HOURS= 0, WORDS= 2000
Essay 60 1-3 15 HOURS= 0, WORDS= 3000
Component 1 subtotal: 40
Component 2 subtotal: 60
Module subtotal: 100

Description of module content:

Good Clinical Practice; EU Clinical Trials Directive; Research Governance; Regulatory Authorities; Independent Ethics Committees/Institutional Review Boards; Local Approval and Inspections/Audits

Learning Outcomes for module:

LO1: Examine the development of regulations in clinical research
LO2: Assess examples of the different regulations that influence clinical research
LO3: Based on best evidence assess the processes that encourage or impede the adoption of these
LO4: Illustrate the process for local approval of a clinical trial

Indicative References and Reading List - URL:

Please contact your Module Leader for details
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