Module title: Clinical Research - Theory (Singapore)

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

Module code: NMS11758
Module leader: Janyne Afseth
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

2018/9, Trimester 3, Blended,
Occurrence: 002
Primary mode of delivery: Blended
Location of delivery: SINGAPORE
Partner:
Member of staff responsible for delivering module: Janyne Afseth
Module Organiser:


Learning, Teaching and Assessment (LTA) Approach:
This module will be delivered using an on-line learning approach via Moodle and Elluminate sessions. Collaborative learning will be promoted through the use of small groups facilitated by a lecturer (LOs 1 and 2). This will allow for discussion of points identified in the the students autonomous learning (LO4). The Moodle units will be offered sequentially to support students through the module content in a paced manner (LO1). Asynchronous discussions with peers and the lecturer will support the students learning and end of unit activities will be provided to promote active learning (LOs 1 and 3). The use of Moodle in this module gives greater flexibility to allow choice to learn at a time which suits students work pattern. Elluminate sessions offer the opportunity to communicate with fellow students to learn through interactive sessions which aim to build on the content of Moodle (LOs 2 and 4). The content of Moodle and the Elluminate tutorials contributes towards meeting LOs 1-4.

Embedding of employability/ Personal Development Plan/ scholarship skills
This module contributes to the your PDP by enhancing your knowledge and skills in critically applying the evidence that underpins your role and applying this to other aspects of clinical research. Completion of this module will enhance the students ability to undertake the their role and assist in their professional development. This module will also link with the WSQ certificates to enhance you career in Clinical Research.



Formative Assessment:
Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3).

Formative assessment is strongly encouraged during the module, which will help the students to develop

Summative Assessment:
Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3).

Formative assessment is strongly encouraged during the module, which will help the students to develop

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 1,2,4 12 HOURS= 0, WORDS= 3500
Report 30 3 9 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100
2018/9, Trimester 3, Online,
Occurrence: 003
Primary mode of delivery: Online
Location of delivery: SINGAPORE
Partner:
Member of staff responsible for delivering module: Janyne Afseth
Module Organiser:


Learning, Teaching and Assessment (LTA) Approach:
This module will be delivered using an on-line learning approach via Moodle and Elluminate sessions. Collaborative learning will be promoted through the use of small groups facilitated by a lecturer (LOs 1 and 2). This will allow for discussion of points identified in the the students autonomous learning (LO4). The Moodle units will be offered sequentially to support students through the module content in a paced manner (LO1). Asynchronous discussions with peers and the lecturer will support the students learning and end of unit activities will be provided to promote active learning (LOs 1 and 3). The use of Moodle in this module gives greater flexibility to allow choice to learn at a time which suits students work pattern. Elluminate sessions offer the opportunity to communicate with fellow students to learn through interactive sessions which aim to build on the content of Moodle (LOs 2 and 4). The content of Moodle and the Elluminate tutorials contributes towards meeting LOs 1-4.

Embedding of employability/ Personal Development Plan/ scholarship skills
This module contributes to the your PDP by enhancing your knowledge and skills in critically applying the evidence that underpins your role and applying this to other aspects of clinical research. Completion of this module will enhance the students ability to undertake the their role and assist in their professional development. This module will also link with the WSQ certificates to enhance you career in Clinical Research.

Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3).

Formative assessment is strongly encouraged during the module, which will help the students to develop

Formative Assessment:
Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3).

Formative assessment is strongly encouraged during the module, which will help the students to develop

Summative Assessment:
Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3).

Formative assessment is strongly encouraged during the module, which will help the students to develop

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 1,2,4 12 HOURS= 0, WORDS= 3500
Report 30 3 9 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100
2019/0, Trimester 1, Blended,
Occurrence: 001
Primary mode of delivery: Blended
Location of delivery: SINGAPORE
Partner:
Member of staff responsible for delivering module: Janyne Afseth
Module Organiser:


Learning, Teaching and Assessment (LTA) Approach:
This module will be delivered using an on-line learning approach via Moodle and Elluminate sessions. Collaborative learning will be promoted through the use of small groups facilitated by a lecturer (LOs 1 and 2). This will allow for discussion of points identified in the the students autonomous learning (LO4). The Moodle units will be offered sequentially to support students through the module content in a paced manner (LO1). Asynchronous discussions with peers and the lecturer will support the students learning and end of unit activities will be provided to promote active learning (LOs 1 and 3). The use of Moodle in this module gives greater flexibility to allow choice to learn at a time which suits students work pattern. Elluminate sessions offer the opportunity to communicate with fellow students to learn through interactive sessions which aim to build on the content of Moodle (LOs 2 and 4). The content of Moodle and the Elluminate tutorials contributes towards meeting LOs 1-4.

Embedding of employability/ Personal Development Plan/ scholarship skills
This module contributes to the your PDP by enhancing your knowledge and skills in critically applying the evidence that underpins your role and applying this to other aspects of clinical research. Completion of this module will enhance the students ability to undertake the their role and assist in their professional development. This module will also link with the WSQ certificates to enhance you career in Clinical Research.



Formative Assessment:
Assessment (formative or summative)
Summative assessments:
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3)
3,500 word Essay (to demonstrate learning 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.


Summative Assessment:
Assessment (formative or summative)
Summative assessments:
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3)
3,500 word Essay (to demonstrate learning 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.


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 1,2,4 12 HOURS= 0, WORDS= 3500
Report 30 3 9 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100
2019/0, Trimester 2, Blended,
Occurrence: 002
Primary mode of delivery: Blended
Location of delivery: SINGAPORE
Partner:
Member of staff responsible for delivering module: Janyne Afseth
Module Organiser:


Learning, Teaching and Assessment (LTA) Approach:
This module will be delivered using an on-line learning approach via Moodle and Elluminate sessions. Collaborative learning will be promoted through the use of small groups facilitated by a lecturer (LOs 1 and 2). This will allow for discussion of points identified in the the students autonomous learning (LO4). The Moodle units will be offered sequentially to support students through the module content in a paced manner (LO1). Asynchronous discussions with peers and the lecturer will support the students learning and end of unit activities will be provided to promote active learning (LOs 1 and 3). The use of Moodle in this module gives greater flexibility to allow choice to learn at a time which suits students work pattern. Elluminate sessions offer the opportunity to communicate with fellow students to learn through interactive sessions which aim to build on the content of Moodle (LOs 2 and 4). The content of Moodle and the Elluminate tutorials contributes towards meeting LOs 1-4.

Embedding of employability/ Personal Development Plan/ scholarship skills
This module contributes to the your PDP by enhancing your knowledge and skills in critically applying the evidence that underpins your role and applying this to other aspects of clinical research. Completion of this module will enhance the students ability to undertake the their role and assist in their professional development. This module will also link with the WSQ certificates to enhance you career in Clinical Research.

Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role.
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3).



Formative Assessment:
Assessment (formative or summative)
Summative assessments:
1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3)
3,500 word Essay (to demonstrate learning 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role. Formative assessment is strongly encouraged during the module, which will help the students to develop.


Summative Assessment:
Assessment (formative and summative)
Summative assessments:
3,500 word Essay (to demonstrate learning outcomes 1, 2 and 4). This essay will allow the students to critically explore how the theoretical aspects of clinical research impact on the conduct of research and also their role. 1,500 Critical analysis of Ethical principles and theories that relate to this topic (LO 3). Formative assessment is strongly encouraged during the module, which will help the students to develop.


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 1,2,4 12 HOURS= 0, WORDS= 3500
Report 30 3 9 HOURS= 0, WORDS= 1500
Component 1 subtotal: 70
Component 2 subtotal: 30
Module subtotal: 100

Description of module content:

The module includes:
Exploration of research paradigms and research design; phases of clinical trials; biostatistics in Clinical Research; theories and principles of Ethics; Good Manufacturing Practice; investigation of Ethics in Research; exploration of key characteristics of quantitative research; critical appraisal of evidence

Learning Outcomes for module:

LO1: Identify and challenge the rationale/limitations underlying a key research paradigm and research approach
LO2: Critically appraise the research design and research strategies employed within clinical research
LO3: Critique the theory underpinning the ethical dimensions of clinical research
LO4: Synthesise the evidence from a body of literature and draw coherent conclusions about the importance of the theoretical underpinnings of the professional roles in clinical research.

Indicative References and Reading List - URL:

Core - BRUCE, N (2008) QUANTITATIVE METHODS FOR HEALTH RESEARCH: A PRACTICAL INTERACTIVE GUIDE TO EPIDEMIOLOGY AND STATISTICS: JOHN WILEY, 1st ed. - ISBN: 9780470022740
Core - ELWOOD, M (2007) CRITICAL APPRAISAL OF EPIDEMIOLOGICAL STUDIES AND CLINICAL TRIALS: OXFORD UNIVERSITY PRESS, 3rd ed. - ISBN: 9780199218257
Core - HACKSHAW A. K A CONCISE GUIDE TO CLINICAL TRIALS: WILEY BLACKWELL, 1st ed. - ISBN: 9781444311716
Core - PIANTADOSI S (2007) CLINICAL TRIALS – A METHODOLOGIC PERSPECTIVE: HOBOKEN: WILEY INTERSCIENCE, 2nd ed. - ISBN: 9780471740124
Core - GRIFFIN J. P., POSNER, J. AND BARKER, G. R. (2013) THE TEXBOOK OF PHARMACEUTICAL MEDICINE: WILEY-BLACKWELL : BMJ BOOKS, 7th ed. - ISBN: 9781118532331
Core - MCGAVOCK H (2011) HOW DRUGS WORK: BASIC PHARMACOLOGY FOR HEALTHCARE PROFESSIONALS: 9781846194788, 3rd ed. - ISBN: 9781846194788
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