The “Professional Project in Clinical Research” is a 60 CATS module that will enable students to identify, understand, appraise and plan research related to clinical research. The module will build on the students' learning in the PG Diploma, allowing them to explore different research methods and giving them the opportunity to apply these skills and understanding to develop, design and deliver a research project relevant to clinical research. The module will cover the skills needed to identify, appraise and synthesise research evidence and develop an understanding of the implications of research for in a clinical setting. Students will explore and apply different research approaches including systematic reviewing, quantitative, qualitative and mixed methods research, and the application of various sampling, data collection and data analysis methods. Working independently, and under limited supervision, students will then take responsibility for the direction and management of a project through to completion and submission.
Principal module aims
This module enables students to:
To develop students' knowledge and understanding of research methods and principles.
To develop students’ ability to critically evaluate an area of practice relevant to clinical research.
To develop students’ ability to critically appraise the research literature and synthesise their findings.
To develop students’ ability to undertake substantial independent study.
To develop students’ ability to produce and communicate a piece of work informed by the forefront of research and evaluation, and with the potential for publication for a professional audience.
1. Develop an appropriate research proposal and protocol that addresses a research question or evaluates an area of clinical study.
2. Demonstrate self-direction and originality in the critical evaluation and synthesis of research evidence in a clinical area.
3. Apply the principles and techniques of critical appraisal to evaluate the limitations of research evidence.
4. Apply ethical values and principles in the context of health services research, including application for ethical approval and the role of ethics committees.
5. Produce work commensurate with an advanced level of skill in planning, information gathering and data interpretation for research enquiry.
6. Apply independent analytical and critical thinking skills.
7. Write succinctly in the format of an academic article for an appropriate professional journal and present work visually in the format of an academic poster.
8. Apply the skills to, plan, conduct, and complete a significant piece of academic writing which addresses an area of health services research.
This module will introduce students to different research methods and then give them the opportunity to apply these skills and understanding to develop, design and deliver a professional project relevant to clinical research.
The module addresses the following areas:
· Literature searching.
· Formulating a research question.
· Study design.
· Writing a research protocol.
· Presenting a research protocol.
· Preparing a poster presentation.
· Critical writing.
· Writing for publication.
Given the nature of Clinical Research, it is envisaged the most common projects will involve: :
Secondary analysis of existing data
There is significant value in the analysis of existing data sets, however students will work with their supervisor to ensure their Professional Project ads to the value of the existing study by considering issues not evident in the original study, a new research question, or by presenting an alternative perspective on the original question. In this regard, solely carrying out more in-depth statistical analysis on existing data would be considered insufficient for the Professional Project.
Creation of protocol
The expectation is that this type of project would involve the planning of a significant piece of research (e.g., a complex, multi-centre Randomised Control Trial). Students will be expected to complete a full proposal including, but not limited to: study design, ethical considerations, participation recruitment and management strategies, patient information leaflets, study questionnaires, data collection and analysis strategies, data protection policies etc.
Sensitivity studies for subsequent investigations
It is expected sensitivity studies will comprehensively assess the robustness of an existing study by examining the extent to which the observed results are affected by changes in analysis methods, outcome definitions, values of unmeasured variables, protocol deviations, compliance etc.
Service improvement / Clinical audits
These project types are potentially suitable if they are conducted under rigorous methodology, demonstrate suitably rigorous study design and execution, and are within the bounds of course delegated ethical approval.
For all the above, strong guidance will be provided to students to ensure the scope of projects is feasible within the context of the module
Research Project – Poster Presentation (20%)
Research Project – 4,000 word journal article (80%)