Module title: Clinical Research – Legislation and Regulation (MDIS Singapore)

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

Module code: NMS11767
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, 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:
The LTA approach for this module is a fully online module. It will be delivered online via Moodle and Webex live online lectures and tutorials (LOs 1-4). Moodle units offered will provide students with learning resources in a logical progression that supports their learning around the complexities of legislation and regulation in clinical research (LOs 1-4). 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 learning throughout the module (LOs1-4). These discussions include specific questions about the each Moodle unit which stimulates the student’s critical and analytical thinking in relation to the content (LOs 1-4). The use of Moodle gives greater flexibility so students can choose to learn at a time which suits their work pattern. Webex sessions offer the opportunity to communicate with fellow students in small groups to learn through interactive teaching sessions and tutorials which aim to build on the content of Moodle (LOs 1-4).

Formative Assessment:
Students will be asked to submit in week 8 an outline in the form of a patchwork text (approx. 750 words) on a relevant regulatory or legislative issue outlining the complexity in relation to application in clinical research practice. Students will be guided to clearly conceptualise the relevant regulation or legislation which is a core element of their summative assessment. Students will be asked to rate themselves against a marking criteria after which academic feedback will be provided.

Summative Assessment:
3,500 word Essay to demonstrate a comprehensive analysis of the complex relationship between legislation/regulation and its application to clinical research practice (LOs 1-4). This will be submitted in week 14.

Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Online Lecture 5
Independent Learning Guided independent study 172
Online Groupwork (Independent Study) 20
Online Tutorial 3
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Essay 100 1,2,3 & 4 14 HOURS= 0, WORDS= 3500
Component 1 subtotal: 100
Component 2 subtotal: 0
Module subtotal: 100
2019/0, Trimester 2, Online,
Occurrence: 002
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:
The LTA approach for this module is a fully online module. It will be delivered online via Moodle and Webex live online lectures and tutorials (LOs 1-4). Moodle units offered will provide students with learning resources in a logical progression that supports their learning around the complexities of legislation and regulation in clinical research (LOs 1-4). 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 learning throughout the module (LOs1-4). These discussions include specific questions about the each Moodle unit which stimulates the student’s critical and analytical thinking in relation to the content (LOs 1-4). The use of Moodle gives greater flexibility so students can choose to learn at a time which suits their work pattern. Webex sessions offer the opportunity to communicate with fellow students in small groups to learn through interactive teaching sessions and tutorials which aim to build on the content of Moodle (LOs 1-4).

Formative Assessment:
Students will be asked to submit in week 8 an outline in the form of a patchwork text (approx. 750 words) on a relevant regulatory or legislative issue outlining the complexity in relation to application in clinical research practice. Students will be guided to clearly conceptualise the relevant regulation or legislation which is a core element of their summative assessment. Students will be asked to rate themselves against a marking criteria after which academic feedback will be provided.

Summative Assessment:
3,500 word Essay to demonstrate a comprehensive analysis of the complex relationship between legislation/regulation and its application to clinical research practice (LOs 1-4). This will be submitted in week 14.

Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Online Lecture 5
Independent Learning Guided independent study 172
Online Groupwork (Independent Study) 20
Online Tutorial 3
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Essay 100 1,2,3 & 4 14 HOURS= 0, WORDS= 3500
Component 1 subtotal: 100
Component 2 subtotal: 0
Module subtotal: 100

Description of module content:

On this module students will learn about the regulatory and legislative infrastructure that affects and influences clinical research. International and national examples will be used to demonstrate a range of perspectives so that students can explore how this area can directly impact on the design, conduct and reporting of clinical research within the students’ country of practice. Completion of this module will enhance the ability to undertake the clinical research assistant role, other clinical research roles and assist in student’s development within the field of Clinical Research.
This module will provide the knowledge and skills to be able to critically appraise how the legislative and regulatory infrastructure influence clinical research and/or student’s role within the clinical research environment.

The module will focus on Good Clinical Practice; Singapore, European and United States and other country/region Clinical Trials Regulations; Research Governance; Roles, impact and responsibly of Regulatory Authorities; Independent Ethics Committees/Institutional Review Boards (IRBs); Fraud and Misconduct; Safety regulations; Local Approval and Inspections/Audits

Learning Outcomes for module:

LO1: Conceptualise the different regulations and legislation that influence clinical research
LO2: Exercise critical judgment on the impact of regulation/legislation on clinical research practice
LO3: Critically reflect upon the processes that encourage or impede the adherence to relevant legislation and regulation.
LO4: Critically evaluate how regulation/legislation impacts the design of clinical research

Indicative References and Reading List - URL:

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