Module title: Clinical Research - Practice

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

Module code: NMS11160
Module leader: Janyne Afseth
School School of Health & Social Care
Subject area group: Nursing in Acute interventions
Prerequisites

N/A

2018/9, Trimester 3, Blended, Edinburgh Napier University
Occurrence: 002
Primary mode of delivery: Blended
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 using a blended learning approach via Moodle, Elluminate Live and face-to-face classes. Face to Face teaching will allow students to explore the module contact required within LO 1 & 2. Collaborative learning will be promoted through the use of small groups facilitated by a lecturer to assure the students the experience to meet LO 2 and 4. Workshops activities allow students to demonstrate the learning required for them to achieve LO 3.

Moodle units offered to support students before, during and after the delivery of their face to face learning will provide students with additional material. 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. Face-to-face classes and Elluminate sessions offer the opportunity to get together 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, the face-to-face 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 clinical research roles and evaluating its appropriateness for implementation in practice. During the module, students will enhance a range of skills including their IT skills; communication (both face to face and online); team working and negotiaition and reflection.



Formative Assessment:
There is an opportunity for formative assessment and feedback, through the submission of draft material on Moodle. This will aid students in refining their summative written assessments.

Summative Assessment:
There are two summative assessments:
Component 1: Portfolio consisting of an Objective Structured Clinical Examination (OSCE) ‘interview’ (20 mins) as a clinical research associate (CRA) or clinical trials monitor. This will be followed up with a reflective assessment (1,500 words) where students appraise their performance as a CRA and their understanding of the principals involved in this role (Week 8) (LO 1&2)
Component 2: An essay critically analysing Good Clinical Practice guidelines and their application to clinical research practice (2,000 words) (LO 1-4) (Week 15).


Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Face To Face Lecture 25
Independent Learning Guided independent study 150
Independent Learning Groupwork (Independent Study) 20
Online Groupwork (Independent Study) 5
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Portfolio 40 1,2 10 HOURS= 0, WORDS= 1500
Essay 60 1-4 15 HOURS= 0, WORDS= 2000
Component 1 subtotal: 40
Component 2 subtotal: 60
Module subtotal: 100
2019/0, Trimester 2, Blended, Edinburgh Napier University
Occurrence: 002
Primary mode of delivery: Blended
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 using a blended learning approach via Moodle, WebEx and face-to-face classes. Face to Face teaching will allow students to explore the module contact required within LO 1 & 2. Collaborative learning will be promoted through the use of small groups facilitated by a lecturer to assure the students the experience to meet LO 2 and 4. Workshop activities allow students to demonstrate the learning required for them to achieve LO 3.

Moodle units offered to support students before, during and after the delivery of their face to face learning will provide students with additional material. 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. Face-to-face classes and WebEx sessions offer the opportunity to get together with fellow students in small groups to learn through interactive teaching sessions that build on the content of Moodle. The content of Moodle, face-to-face lectures and submission of assignments contribute towards meeting LOs 1-4.

Embedding of employability/ PDP/ scholarship skills
This module contributes to the students PDP by enhancing higher level knowledge and skills that underpin clinical research roles and evaluating their appropriateness for implementation in practice. During the module, students will enhance a range of skills including their IT skills; communication; team working; negotiation and reflection.


Formative Assessment:
There is an opportunity for formative assessment and feedback, through the submission of draft material on Moodle. This will aid students in refining their summative written assessments.

Summative Assessment:
There are two summative assessments:
Component 1: Portfolio consisting of an Objective Structured Clinical Examination (OSCE) ‘interview’ (20 mins) as a clinical research associate (CRA) or clinical trials monitor. This will be followed up with a reflective assessment (1,500 words) where students appraise their performance as a CRA and their understanding of the principals involved in this role (Week 8) (LO 1&2)
Component 2: An essay critically analysing Good Clinical Practice guidelines and their application to clinical research practice (2,000 words) (LO 1-4) (Week 15).


Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Face To Face Lecture 15
Independent Learning Guided independent study 170
Face To Face Groupwork (Scheduled) 15
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Portfolio 40 2,3 10 HOURS= 0, WORDS= 1500
Essay 60 1-4 15 HOURS= 0, WORDS= 2000
Component 1 subtotal: 40
Component 2 subtotal: 60
Module subtotal: 100

Description of module content:

On this module you will learn about the knowledge and skills required to be able to critically appraise the practical aspects of the professional roles in clinical research; and to apply this knowledge to enhance your ability to improve your practice. Completion of this module will enhance your ability to undertake your role and assist in your development within the field of Clinical Research.
The module content includes subjects such as: Critical Reflection; Monitoring and audit of Clinical Trials; Local trial responsibilities; Standard Operating Procedures; Ethical and managerial approval; Data Management; Informed consent; Drug accountability and Communications skills; Exploration of issues related to professional roles in clinical research. The online element of the delivery includes searching, locating and reviewing the literature, the reflective cycle, ethical dilemmas and informed consent.

Learning Outcomes for module:

LO1: Critically reflect and engage with the theoretical aspects of the professional roles in clinical research and recognise its practical application
LO2: Engage in critical dialogue with evidence regarding the major elements of the practical management of clinical research
LO3: Exercise appropriate judgement whilst applying the theoretical aspects of clinical research to practice
LO4: Critically evaluate the importance of working within a team in clinical research

Indicative References and Reading List - URL:

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