Introductory description

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 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 research project through to completion and submission.

Module web page

Module aims

Outline syllabus

This is an indicative module outline only to give an indication of the sort of topics that may be covered. Actual sessions held may differ.

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 Research Project relevant to clinical research.
The module addresses the following areas:

• Literature searching.
• Formulating a research question.
• Study design.
• Writing a Research Project.
• Presenting a Research Project.
• Preparing a poster presentation.
• Critical writing.
• Writing for publication.

A central element of the module is the Research Project.
A number of different types of activities will be available to be undertaken as a Research Project, and students will discuss ideas with their tutors and Supervisor in order to decide the most appropriate approach.
Given the nature of clinical research, it is envisaged the most common projects will include:

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 Research Project adds 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.

Creation of a research protocol
The expectation is that this type of Research 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 research protocol 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 Research Projects 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 Research Projects, strong guidance will be provided to students and supervisors to ensure the project is feasible within the context of the module.

The module will commence with a series of structured small group tutorials which will provide a forum for students to recap key concepts of research design from previous modules (as they relate to the Professional Project) and to have group discussion on their proposed Research Projects as they progress towards submission of a Research Proposal for academic and ethical approval.

Students will deliver a Formative Assessment in the form of a pre-recorded Oral Presentation of their Research Proposal.

Students will receive feedback from a selection of their peers, their supervisor and one other academic reviewer.

Students will deliver 3 pieces of work for Summative Assessment:

• Research Proposal (pass/fail)
• Poster Presentation – delivered live (20%)
• Journal Article or Research Protocol Submission (80%)

Learning outcomes

By the end of the module, students should be able to:

• 1. Develop an appropriate research proposal 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. Demonstrate understanding of ethical values and principles in the context of health services research, how to apply 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. Demonstrate the skills to plan, conduct, and complete a significant piece of academic writing which addresses an area of health services research.

Research element

Students will undertake a Research Project under the guidance of a supervisor.
The initial part of the module will cover the skills needed to identify, appraise, and synthesise research evidence and develop an understanding of the implications of research. It will introduce students to different research approaches (including systematic reviewing, quantitative, qualitative, and mixed methods research) and will explore the application of various sampling, data collection and data analysis methods. At the end of this first phase, the student will submit a research proposal that, once approved, will be used for the ‘research’ phase of the module.

Students will be able to undertake a wide range of Research Projects, including projects that may require ethical approval. The expectation is that the process will be similar to that used for the ethical review of research projects on our other MSc courses with iheed.
Briefly:

• All students will complete a BSREC application form for ethical approval.
• The forms will be assessed by the Course Directors (and moderated by the Programme Director).
  o Possible outcomes:
  A. Insufficient details provided – proposal returned to student
  B. Project does not require ethical approval
  C. Project meets the criteria for course-delegated ethical approval
  D. Project meets the criteria for course-delegated approval, subject to minor revisions
  E. Project requires ethical approval from BSREC – proposal is submitted to BSREC
  F. Project requires approval from a Local or National Health Authority and is rejected.
  We will confirm this process with BSREC when the course is approved.

Interdisciplinary

Clinical practice necessitates collaboration across disciplines, and it is appropriate that this is reflected in the Masters in Clinical Research. The module is designed to appeal to a range of clinical professionals, including medical, nursing, pharmaceutical, bioscience and other disciplines.

International

The course will recruit from (and be delivered in) multiple territories, and the content will be tailored to the students’ own territories, reflecting local and international standards for clinical research integrity.

Subject specific skills

Subject-specific skills that will be obtained from the module include:

• Knowledge and understanding of research methods and principles.
• Ability to critically evaluate an area of professional practice relevant to clinical research.
• Ability to critically appraise the research literature and synthesise findings.
• Ability to produce and communicate a piece of work informed by the forefront of research and evaluation.

Transferable skills

Transferable skills that will be developed during the module include:

• Written communication.
• Oral communication.
• Numeracy.
• Thinking and problem solving.
• Organisation and time management.
• Use of tools and technology.
• Independence and initiative.
• Adaptability and flexibility.