Module title: Clinical Research - Legislation and regulation

SCQF level: 11:
SCQF credit value: 20.00
ECTS credit value: 10

Module code: NMS11159
Module leader: Janyne Afseth
School School of Health & Social Care
Subject area group: Nursing in Acute interventions
Prerequisites

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

2018/9, Trimester 3, Online, Edinburgh Napier University
Occurrence: 002
Primary mode of delivery: Online
Location of delivery: SIGHTHILL
Partner: Edinburgh Napier University
Member of staff responsible for delivering module: Janyne Afseth
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 2, 3 and 4. This will allow for discussion of points identified in the the students autonomous learning (LO 2 and 4).
Moodle units offered to support students will provide students with additional material to achieve LO3. 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 your PDP by enhancing students knowledge and skills in critically applying the evidence that underpins the regulations and legislation pertaing to clinical research, and evaluating its appropriateness for implementation in practice. Completion of this module will enhance the students ability to undertake their role



Formative Assessment:
Formative assessment is encouraged during the module, which will help the students to develop towards the summative assessments. There is also the opportunity for formative assessment utilising on-line activities via Moodle and through submission of draft material.


Summative Assessment:
1,500 word critical analysis on the role/impact of Ethics committees on clinical research (LOs 2 & 3)
3,500 word Essay to demonstrate a comprehensive understanding of the complex relationship between legislation/regulation and clinical research (LOs 1-4)

Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Online Lecture 5
Independent Learning Guided independent study 175
Independent Learning Groupwork (Independent Study) 20
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Essay 70 1-4 15 HOURS= 0, WORDS= 3500
Report 30 2,3 12 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100
2019/0, Trimester 1, Online, Edinburgh Napier University
Occurrence: 001
Primary mode of delivery: Online
Location of delivery: SIGHTHILL
Partner: Edinburgh Napier University
Member of staff responsible for delivering module: Janyne Afseth
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 2, 3 and 4. This will allow for discussion of points identified in the the students autonomous learning (LO 2 and 4).
Moodle units offered to support students will provide students with additional material to achieve LO3. 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 your PDP by enhancing students knowledge and skills in critically applying the evidence that underpins the regulations and legislation pertaing to clinical research, and evaluating its appropriateness for implementation in practice. Completion of this module will enhance the students ability to undertake their role



Formative Assessment:
Formative assessment is encouraged during the module, which will help the students to develop towards the summative assessments. There is also the opportunity for formative assessment utilising on-line activities via Moodle and through submission of draft material.


Summative Assessment:
1,500 word critical analysis on the role/impact of Ethics committees on clinical research (LOs 2 & 3)
3,500 word Essay to demonstrate a comprehensive understanding of the complex relationship between legislation/regulation and clinical research (LOs 1-4)


Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Online Lecture 5
Independent Learning Guided independent study 175
Independent Learning Groupwork (Independent Study) 20
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Essay 70 1-4 18 HOURS= 0, WORDS= 3500
Report 30 2, 3 13 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100
2019/0, Trimester 2, Online, Edinburgh Napier University
Occurrence: 002
Primary mode of delivery: Online
Location of delivery: SIGHTHILL
Partner: Edinburgh Napier University
Member of staff responsible for delivering module: Janyne Afseth
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 2, 3 and 4. This will allow for discussion of points identified in the the students autonomous learning (LO 2 and 4).
Moodle units offered to support students will provide students with additional material to achieve LO3. 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 your PDP by enhancing students knowledge and skills in critically applying the evidence that underpins the regulations and legislation pertaing to clinical research, and evaluating its appropriateness for implementation in practice. Completion of this module will enhance the students ability to undertake their role



Formative Assessment:
Formative assessment is encouraged during the module, which will help the students to develop towards the summative assessments. There is also the opportunity for formative assessment utilising on-line activities via Moodle and through submission of draft material.


Summative Assessment:
1,500 word critical analysis on the role/impact of Ethics committees on clinical research (LOs 2 & 3)
3,500 word Essay to demonstrate a comprehensive understanding of the complex relationship between legislation/regulation and clinical research (LOs 1-4).


Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Online Lecture 5
Independent Learning Guided independent study 175
Independent Learning Groupwork (Independent Study) 20
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Essay 70 1-4 15 HOURS= 0, WORDS= 3500
Report 30 2,3 12 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100

Description of module content:

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

Learning Outcomes for module:

LO1: Conceptualise the different regulations and legislation that influence clinical research
LO2: Critically evaluate the impact of regulation/legislation on clinical research practice
LO3: Critically reflect upon the processes that encourage or impede the adoption of these
LO4: Critically evaluate how Regulations/legislation has impacted on the design of clinical research

Indicative References and Reading List - URL:

Please contact your Module Leader for details
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