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The University of Southampton
Courses

HLTH6199 Conducting Clinical Research

Module Overview

This module will allow you to explore the requirements for conducting research in clinical and health settings. It is particularly suited to those working in clinical research and those who are planning an empirical research study in clinical and health settings.

Aims and Objectives

Learning Outcomes

Learning Outcomes

Having successfully completed this module you will be able to:

  • Critically examine the delivery of clinical and health research, demonstrating an understanding of the impact of research and development policies, governance and regulations on project delivery
  • Demonstrate an understanding of evidence relevant to the conduct of research in clinical and health settings.
  • Identify potential challenges in, and devise recommendations for, conducting appropriate and feasible clinical and health research
  • Where relevant, critically evaluate your own clinical research practice, considering both your personal development needs and your practice context
  • Critically explore issues in relation to ethics, governance, data protection in the conduct of clinical and health research

Syllabus

Content for this module may include: 1. Research roles and responsibilities 2. Managing research in clinical practice 3. Ethical issues relating to the conduct of research in clinical practice, including for example local and national ethical approval process, data utilisation, risk assessments and Research Governance. 4. Processes for NHS patients/staff, use of routine NHS data and data collection outside the NHS 5. Consideration of data recording, storage archiving and data protection 6. Conduct of research in health and clinical setting, including for example sampling approaches, access, recruitment, retention, consent, working in teams and with gatekeepers 7. Time management, project management tools, good practice, record keeping, report writing 8. The regulatory environment – national and international

Learning and Teaching

Teaching and learning methods

The format of taught sessions may include lectures and workshop/seminars, which will draw on expertise and examples of recent and ongoing clinical and health-related research in the University and NHS, self directed learning, and independent study supported by web resources, including Blackboard.

TypeHours
Independent Study220
Teaching30
Total study time250

Resources & Reading list

Department of Health: Research governance framework for health and social care.

Lenfant C (2016). Clinical Research in Practice: a guide for the bedside scientist. 

Portney IG (2009). Foundations of Clinical Research. Applications to Practice. 

Assessment

Assessment Strategy

The formative assessment will comprise a group activity reviewing examples of research conduct challenges and developing recommendations. Completion of the summative assessment for this module, as follows: You will presented with 5 scenarios representing challenges or issues relevant to the conduct of research in clinical or health settings. You will choose 3 of the 5 scenarios for your assignment, providing a brief rationale for your choice. You will discuss solutions to the chosen scenarios, supporting your recommendations with critical appraisal of relevant literature and with reference to relevant policy and legislation The assignment will be 3,500 words +/-10%. In total Feedback Method For the formative assessment, students will receive verbal feedback from the group facilitator. For the summative assessment, students will receive detailed written feedback highlighting strengths of the assignment and areas for development. A pass mark of 50% must be achieved in this summative assessment to successfully complete this module.

Formative

Small Group Discussion

Summative

MethodPercentage contribution
Short essay /assignment  (3500 words) 100%

Repeat Information

Repeat type: Internal

Linked modules

Pre-requisites

To study this module, you will need to have studied the following module(s):

CodeModule
HLTH6200Design & Methods for Clinical and Health Research
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