Course Overview

Objective of the MSc in Clinical Research

The MSc in Clinical Research is designed to equip the next generation of healthcare professionals with the skills and knowledge to excel in the clinical research field. This program serves as a pathway for transforming medical discoveries into clinical applications, fostering efficiency and innovation. 

Tailored for qualified individuals aiming to become independent clinical investigators or assume leadership roles in clinical research teams, the course integrates theoretical knowledge with hands-on experience. Core topics include study design, data analysis, ethical frameworks, and regulatory compliance, ensuring a comprehensive foundation in clinical research methodology. 

The program offers flexible study options: 

  • Full-time: Complete the MSc in one year. 
  • Part-time: Pursue the Clinical Research Methodology track over two years. 

Year 1 is conducted at the University of Galway, while Year 2 combines distance learning with on-site modules provided by the University. 

This dynamic program empowers healthcare professionals to make a meaningful impact in advancing medical science and improving patient care. 

Celebrating a remarkable milestone! Congratulations to the MSc Clinical Research programme on producing over 300 exceptional graduates since 2011. Your contributions to advancing clinical research ehave been invaluable to healthcare innovation and patient care. 

To all graduates: Your dedication to advancing healthcare through research and analytics is truly inspiring. Wishing you continued success as you apply your expertise to transform patient care and medical research!  

Clinical graduation 2024

MSc Clinical Research Class of 2023 Graduation, November 2024 

Special Features of the MSc in Clinical Research

Under the guidance of experienced professionals and researchers from University of Galway and Saolta University Health Care Group, students will gain valuable insights into clinical trials, evidence-based medicine, and patient-centered research. This program is closely linked with the Institute for Clinical Trials and the HRB Clinical Research Facility, Galway.

Course Webinar Recording Watch the recording from the Virtual Postgraduate Open Day, November 2020, , here.

 

Clinical Research pic

HRB Fellows

Photo of HRB-CRFG Fellowship Students from 2022, L–R:: Frank Wu, Aoife Lyons, Laith Al-Sabek

Clinical Trial Fellowship

  • For the information document, please click here.
  • To download the form referenced in the information document, click here.

Clinical Trial Fellowship Eligibility

  • Offered and accepted a full-time position in the MSc in Clinical Research program.
  • Available to commit to working 20 hours per week in the Clinical Research Facility or an affiliated research department.

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Applications and Selections

Applications are made online via the University of Galway Postgraduate Applications System

Who Teaches this Course

Requirements and Assessment

Assessment will take the form of formal, end-of-module examinations as well as continuous assessment, evaluation of contribution to group discussions and module projects. Semester One exams take place in December; Semester Two exams take place in April/May. The research thesis is submitted in August.

Key Facts

Entry Requirements

Students must have completed one of the following: 

  1. An undergraduate degree in medicine.
  2. Another healthcare-related undergraduate degree with a minimum of 2nd Class Honours
  3. A biomedical science-related undergraduate degree with a minimum of 2nd Class Honours 

Applicants from non-healthcare related degrees will be considered on a case-by-case basis at the discretion of the coordinators (minimum requirement of 2nd Class Honours). Applicants with significant relevant experience will also be considered. 

All applicants whose first language is not English, or who have not been educated through the medium of English language during their two most recent years of study, must meet the University of Galway's English Language Requirements. For details on accepted qualifications, please refer to the

The University no longer accept Duolingo for entry. However, if your level is below IELTS 6.5, you could do a pre-sessional course aimed at preparing you for progression to this course. 

Applicants who do not meet the primary entry criteria as described above will be declined entry into the program.  

The remaining applicants will be reviewed in closer detail, with significant weight placed on: A) The applicant’s personal statement describing their motivation for applying to this course and their career aspirations following the successful completion of the MSc. B) The applicant’s previous academic performance. C) The applicant’s referee’s comments. 

This programme is eligible under the Interim List of Eligible Programmes (ILEP,  Ireland's official register of approved educational programs that can accept international students requiring study visas, ensuring programs meet quality standards for immigration purposes. 

Additional Requirements

Recognition of Prior Learning (RPL)

Applicants with significant relevant experience will also be considered for this programme.

Duration

1 year, full-time
2 years, part-time

Next start date

September 2025

A Level Grades ()

Average intake

20

QQI/FET FETAC Entry Routes

Closing Date

No set closing date. Please see offer rounds website for further information.

NFQ level

9

Mode of study

ECTS weighting

90 ECTS

Award

CAO

Course code

MCR1, MCR2

Course Outline

Full-time MSc (Clinical Research) 

Full-time or part-time course consisting of 90 ECTS. 

Compulsory Modules (Core): 

Semester 1 

MD510 Fundamentals of Health Research and Evaluation Methods; 10ECTS 
MD511 Introduction to Biostatistics I; 10ECTS 
MD1602 Introduction to the Ethical and Regulatory Frameworks of Clinical Research; 10ECTS 

Additional Modules (Optional):  

Semester 1 and 2

MD513 Introduction to Biostatistics II; 10ECTS 
MD514 Introduction to Research Methods for Randomized Controlled Trials; 10ECTS 
MD515 Systematic Review Methods; 10ECTS 
MD1541 Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics; 10 ECTS 
MD1603 Clinical Research Site Level Activities; 10 ECTS 
MD517 Clinical Research Administration; 10ECTS 
EC584 Health Systems and Policy Analysis; 10ECTS 
EC572 Health Technology Assessment; 10ECTS 
MD518 Observational and Analytical Research Methods; 10ECTS 
MD1600 Bio-Ethics; 10ECTS 
MD1601 Biobank—Advanced Clinical Application and Clinical Testing; 10ECTS 

PLUS 

MD520 Minor Thesis (30 ECTS), completed over the one year period. 

Part-time MSc (Clinical Research) 

Students are required to complete three compulsory modules at University of Galway in year 1 of the Masters. A further 3* or 5** modules are selected from additional courses available at University of Galway. 

Semester 1 

MD510 Fundamentals of Health Research and Evaluation Methods; 10ECTS 
MD511 Introduction to Biostatistics I; 10ECTS 
MD1602 Introduction to the Ethical and Regulatory Frameworks of Clinical Research; 10ECTS  

Additional Modules (Optional):  

Semester 1 and 2 

MD513 Introduction to Biostatistics II; 10ECTS 
MD514 Introduction to Research Methods for Randomized Controlled Trials; 10ECTS 
MD515 Systematic Review Methods; 10ECTS 
MD1541 Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics; 10 ECTS 
MD1603 Clinical Research Site Level Activities; 10 ECTS 
MD517 Clinical Research Administration; 10ECTS 
EC584 Health Systems and Policy Analysis; 10ECTS 
EC572 Health Technology Assessment; 10ECTS 
MD518 Observational and Analytical Research Methods; 10ECTS 
MD1600 Bio-Ethics; 10ECTS 
MD1601 Biobank—Advanced Clinical Application and Clinical Testing; 10ECTS 

PLUS 

MD520 Minor Thesis (30 ECTS), completed over the 2- year period. 

OR 

** MD519 Independent Study Module (10 ECTS) completed and assessed by University of Galway. 

 

Curriculum Information

Curriculum information relates to the current academic year (in most cases).
Course and module offerings and details may be subject to change.

Glossary of Terms

Credits
You must earn a defined number of credits (aka ECTS) to complete each year of your course. You do this by taking all of its required modules as well as the correct number of optional modules to obtain that year's total number of credits.
Module
An examinable portion of a subject or course, for which you attend lectures and/or tutorials and carry out assignments. E.g. Algebra and Calculus could be modules within the subject Mathematics. Each module has a unique module code eg. MA140.
Subject
Some courses allow you to choose subjects, where related modules are grouped together. Subjects have their own required number of credits, so you must take all that subject's required modules and may also need to obtain the remainder of the subject's total credits by choosing from its available optional modules.
Optional
A module you may choose to study.
Required
A module that you must study if you choose this course (or subject).
Required Core Subject
A subject you must study because it's integral to that course.
Semester
Most courses have 2 semesters (aka terms) per year, so a three-year course will have six semesters in total. For clarity, this page will refer to the first semester of year 2 as 'Semester 3'.

Curriculum Information

Curriculum information relates to the current academic year (in most cases).
Course and module offerings and details may be subject to change.

Glossary of Terms

Credits
You must earn a defined number of credits (aka ECTS) to complete each year of your course. You do this by taking all of its required modules as well as the correct number of optional modules to obtain that year's total number of credits.
Module
An examinable portion of a subject or course, for which you attend lectures and/or tutorials and carry out assignments. E.g. Algebra and Calculus could be modules within the subject Mathematics. Each module has a unique module code eg. MA140.
Optional
A module you may choose to study.
Required
A module that you must study if you choose this course (or subject).
Semester
Most courses have 2 semesters (aka terms) per year.

Year 1 (90 Credits)

OptionalEC584: Economic Evaluation in Health Care


Semester 1 | Credits: 10

The module examines the theory and practice of economic evaluation as it applies to health and social care interventions. Topics covered include the rationale for economic evaluation; formulating a health evaluation problem; identifying and measuring outcomes and effectiveness; identifying, enumerating, and valuing the inputs to form an economic measure of costs; measuring the benefits of health interventions using contingent valuation and discrete choice experiments
(Language of instruction: English)

Learning Outcomes
  1. Understand the variety of economic evaluation techniques used to evaluate health interventions
  2. Critically assess the different theoretical rationales for health interventions
  3. Understand the different ways for measuring and valuing costs
  4. Understand the various methods for measuring outcomes in cost effectiveness and cost utility analysis
  5. Critically assess the advantages and disadvantages of QALYs
  6. Understand the use of contingent valuation in health economics
  7. Understand the use of experimental techniques to measure the value of interventions in health care
  8. Conduct a literature search and review of CEA and CUA studies in a particular health intervention
Assessments
  • Written Assessment (100%)
Teachers
Reading List
  1. "Methods for the Economic Evaluation of Health Care Programmes" by Drummond, Michael F. et al.
    Publisher: Oxford University Press
  2. "Applied Methods of Cost-effectiveness Analysis in Health Care" by Alastair Gray et al.
    Publisher: Oxford University Press
  3. "Applied Methods of Cost-Benefit Analysis in Health Care" by McIntosh, Emma et al.
    Publisher: Oxford University Press
  4. "The Elgar Companion to Health Economics" by Jones, Andrew M. et al.
    Publisher: Edmund Elgar
The above information outlines module EC584: "Economic Evaluation in Health Care" and is valid from 2019 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD520: THESIS


12 months long | Credits: 30

Research will be performed in the participant’s own speciality with the aim of submitting a Thesis to NUI Galway. Following NUI Galway guidelines, the thesis will require 4 chapters with at least two chapters containing original research, with detailed review of methodological issues in all chapters.
(Language of instruction: English)

Learning Outcomes
  1. Produce a substantial comprehensive literature review describing and critically assessing Clinical Research in a field of your interest
  2. Demonstrate competence and professionalism in written communications.
Assessments
  • Research (100%)
Teachers
The above information outlines module MD520: "THESIS" and is valid from 2023 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD1600: Bio-Ethics


Semester 1 | Credits: 10

This module will provide a comprehensive introduction to bio-ethics in the context of clinical research sciences. The module will instil the importance of balancing the need to advance our knowledge of medicine against the legal and ethical mandate to protect society.
(Language of instruction: English)

Learning Outcomes
  1. Evaluate ethical issues from given scenarios and thus demonstrate a capacity to apply across a broad spectrum.
  2. Evaluate the ethics relating to biobanking and current legislation around informed consent and ethical approval.
  3. Consider the ethics of previous practice and hence demonstrate a capacity to review processes for the advancement of future endeavour.
  4. Evaluate legislation practices and protocols, given consideration to all participants and, create a framework for disseminating learning to both peers and non-peers.
Assessments
  • Continuous Assessment (80%)
  • Department-based Assessment (20%)
Teachers
The above information outlines module MD1600: "Bio-Ethics " and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD1602: Introduction to the Ethical and Regulatory Frameworks of Clinical Research


Semester 1 | Credits: 10

This module is designed to provide an overview of core principles underpinning clinical research practice including the roles and responsibilities of members of the research team. Central to this module are the principles and practical application of Good Clinical Practice (GCP), relevant regulations and legislation, professional guidelines and codes of ethics including ethical dilemmas, vulnerable populations and research integrity.
(Language of instruction: English)

Learning Outcomes
  1. Describe, understand and apply the principles of Good Clinical Practice when designing and undertaking clinical research projects.
  2. Describe and explain the legal and regulatory issues in clinical research
  3. Design, plan and execute research projects with appropriate research governance and operating within applicable ethical and legal frameworks including General Data Protection Regulation (GDPR).
  4. Examine ethical issues in clinical research and select appropriate approaches strategies to navigate
  5. Demonstrate an awareness of ethical practices and professional standards applicable to the field of clinical research
Assessments
  • Continuous Assessment (30%)
  • Department-based Assessment (70%)
Teachers
The above information outlines module MD1602: "Introduction to the Ethical and Regulatory Frameworks of Clinical Research " and is valid from 2023 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD511: Introduction to Biostatistics I


Semester 1 | Credits: 10

The module is designed to provide an introduction to the basics in Biostatistics, to enable students understand concepts of population distribution, sampling, probability, data type and presentation, statistical inference and hypothesis testing.
(Language of instruction: English)

Learning Outcomes
  1. To demonstrate the importance and practical usefulness of statistics
  2. To encourage and equip students to apply simple statistical techniques to design, analyse and interpret studies in a wide range of disciplines
  3. To enable students to communicate the results of their analyses in clear non-technical language in writing up laboratory reports and projects
  4. To make students aware of the limitations of simple techniques and encourage them to seek expert advice when more complex procedures are required
  5. To utilise a statistical package on a computer to illustrate the power of statistical techniques and avoid tedious arithmetic
  6. To provide examples of the uses of statistics in situations of relevance to students' other courses
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Statistics for Sports and Exercise Science: A Practical Approach." by Newell, J., Aitchison, T. and Grant, S.
    Publisher: Pearson Education Limited.
  2. "An Introduction to medical statistics" by Bland M.
    Publisher: UK Oxford University Press.
  3. "Practical Statistics for Medical Research" by Douglas G. Altman
    Publisher: Chapman & Hall/CRC.
  4. "Introduction to the practice of statistics" by Moore, D. S., McCabe, G. P., & Craig, B. A
    Publisher: New York: W.H. Freeman
The above information outlines module MD511: "Introduction to Biostatistics I" and is valid from 2019 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD510: Fundamentals of Health Research & Evaluation Methods


Semester 1 | Credits: 10

Provides a broad overview of clinical research methodology. Module is designed to provide an overview of research methodology, designs and content areas. Including: qualitative methodologies, concept of health, formulation of research questions, literature reviews, study designs, selection of study populations, choice of measuring instruments, and study interpretation issues such as determination of causality and the effectiveness of clinical and community interventions. This course is designed to introduce methodological issues to help students identify further learning objectives related to in‐depth study of specific research methods.
(Language of instruction: English)

Learning Outcomes
  1. To examine quantitative research approaches, and appreciate their strengths and limitations
  2. To learn how to apply these research approaches and methods by completing regular assignments and preparing a research protocol/paper in your own area of interest
  3. Introduce methodological issues to help critically read scientific reports of health research
  4. Grasp major components of research activities, including: study designs, selection of study populations, choice of measuring instruments, formulation of research questions, and study interpretation issues such as determination of causality and the effectiveness of clinical and community interventions.
Assessments
  • Department-based Assessment (100%)
Teachers
Reading List
  1. "Designing Clinical Research" by Stephen B Hulley
    ISBN: 9781608318049.
    Publisher: Lippincott Williams & Wilkins
  2. "Users' guides to the medical literature" by editors, Gordon Guyatt ... [et al.].
    ISBN: 9780071790710.
    Publisher: ; McGraw-Hill Medical
The above information outlines module MD510: "Fundamentals of Health Research & Evaluation Methods" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD1541: Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics


Semester 1 | Credits: 10

This module will cover the molecular biology of cancer and how this knowledge drives development of treatment strategies. Learners will be introduced to key components of the translational paradigm, from laboratory-based experimentation to development of targeted therapies for cancer. The importance of Biobanks for clinical research will be highlighted, and the core aspects required discussed. The potential to use mesenchymal stem cells and their secreted vesicles for cancer therapy will be covered, along with advances in the field towards clinical application. [Please note CAR-T/immune cells are covered in MD1522 and will not form part of this module]
(Language of instruction: English)

Learning Outcomes
  1. Describe key pathways involved in cancer development and progression, and the treatment strategies that target these specific pathways
  2. Describe each stage of the Translational Paradigm, from target discovery through to changing standard of care
  3. Define the key components of a clinically relevant Biobank, highlighting the ethical and infrastructural requirements
  4. Describe the potential for clinical application of Mesenchymal Stem Cells as targeted Cancer therapeutics, and the challenges yet to be overcome
  5. Demonstrate an understanding of the potential of Extracellular Vesicles for Cancer detection and Therapy
Assessments
  • Continuous Assessment (100%)
Teachers
The above information outlines module MD1541: "Harnessing the Basic Biology of Cancer for Development of Novel Therapeutics" and is valid from 2023 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD1603: Clinical Research Site Level Activities


Semester 1 | Credits: 10


(Language of instruction: English)

Learning Outcomes
  1. Preparation of clinical trial protocol and other study associated documentation from a site level perspective
  2. Describe the role and responsibilities of research team and staff involved in clinical trials
  3. List clinical trials types, along with functions and processes during the life cycle of trials
  4. Review the concepts of clinical trial activities from a site level perspective
  5. Preparation of a clinical trial protocol and other study-associated documentation, from the site level perspective.
  6. Comprehension of systems and interactions in the CRF environment from a site level point of view.
Assessments
  • Department-based Assessment (100%)
Teachers
Reading List
  1. "Clinical Trials" by Stuart J. Pocock
    ISBN: 1-118-79392-7.
    Publisher: John Wiley & Sons
  2. "Pragmatic Randomized Clinical Trials" by Cynthia J. Girman,Cynthia J. Girman, DrPH, FISPE,Mary E. Ritchey, PhD, FISPE
    ISBN: 0128176636.
    Publisher: Elsevier
  3. "Design, Execution, and Management of Medical Device Clinical Trials" by Salah M. Abdel-aleem
    ISBN: 0-470-47590-0.
    Publisher: John Wiley & Sons
  4. "Clinical trials explained a guide to clinical trials in the NHS for healthcare professionals" by Derek Stewart
    ISBN: 1281322016.
The above information outlines module MD1603: "Clinical Research Site Level Activities" and is valid from 2023 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD519: Independent Study


Trimester 3 | Credits: 10

Research will be performed in the participant’s own speciality with the aim of writing a scholarly article suitable for submission to a relevant peer-reviewed journal for publication.
(Language of instruction: English)

Learning Outcomes
  1. Reflect on what constitutes a research problem to be addressed in a scientific paper
  2. Organise and compose a scientific paper in accordance with the guidelines outlined in Journal of interest
  3. Analyse and review scientific papers in terms of key message, consistency and justification
Assessments
  • Research (100%)
Teachers
The above information outlines module MD519: "Independent Study" and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.

OptionalEC572: Health Systems & Policy Analysis


Semester 2 | Credits: 10

This is a masters level module that examines the structure, conduct and performance of alternative models of finance and delivery in health care and critically examines the policy approaches developed to tackle key challenges in health and social care. The module builds upon the concept of market failure as it relates specifically to health care; critically appraises methods used to compare system performance and compares alternative systems in terms of performance. The objective of the module is to describe the key aspects of alternative health care systems; explore the evolution of a particular set of systems; examine how system structure relates to its operation and what light this sheds on the performance of those systems.
(Language of instruction: English)

Learning Outcomes
  1. Understand the impact of market failure in health care on health and health care
  2. Have a critical appreciation of the design, operation and evolutionary development of alternative models of health care delivery and finance
  3. Be able to critically appraise alternative measures of health care system performance
  4. Be able to critically appraise alternative models of health care system in terms of performance
  5. Be able to critically appraise policy measures aimed at tackling key challenges for health care systems
  6. Be able to source, gather, interpret and use health and economic data
Assessments
  • Written Assessment (70%)
  • Continuous Assessment (30%)
Teachers
Reading List
  1. "The Elgar companion to health economics" by Andrew Jones
    Publisher: Elgar Publishing
  2. "Economic analysis in health care" by Morris S, Devlin N, Parkin D..
    Publisher: Wiley
  3. "The economics of health and health care." by Folland S, Goodman AC, Stano M.
    Publisher: Pearson Education International
  4. "Health Economics" by Phelps CE
    Publisher: Pearson Education International
  5. "Health Economics: Fundamentals and flow of funds" by Getzen T.
    Publisher: Wiley
  6. "The provision and use of health services, health inequalities and health and social gain" by Nolan B.
    Publisher: ESRI
  7. "Health Policy Issues. An economic perspective on health reform" by Feldstein PJ.
The above information outlines module EC572: "Health Systems & Policy Analysis" and is valid from 2024 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD513: Introduction to Biostatistics II


Semester 2 | Credits: 10

The module is designed to provide an introduction to statistical modelling techniques such as linear and non-linear regression, Analysis of Variance and Survival Analysis.
(Language of instruction: English)

Learning Outcomes
  1. To provide a practical introduction to data analysis;
  2. To encourage and equip students to apply simple statistical techniques to design, analyse and interpret studies in a wide range of disciplines
  3. To make students aware of the limitations of simple techniques and encourage them to seek expert advice when more complex procedures are required
  4. To utilise a statistical package on a computer to illustrate the power of statistical techniques and avoid tedious arithmetic
Assessments
  • Continuous Assessment (100%)
Teachers
The above information outlines module MD513: "Introduction to Biostatistics II" and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD514: Introduction to Research Methods for Randomized Controlled Trials


Semester 2 | Credits: 10

This online/blended course utilizes interactive learning modules, required readings, discussion boards, tutorials and assignments to introduce students to the main elements of clinical trial design, execution and analysis. For aspiring clinical trial researchers, this is an essential introductory course which addresses the formulation of appropriate research questions and trial design for funding purposes.
(Language of instruction: English)

Learning Outcomes
  1. Discuss core concepts of clinical trial design, execution, and analysis
  2. firm grasp of clinical trial methodology at a level that would allow them to prepare detailed clinical trial protocols, suitable for submission to clinical research sponsors, funders, ethics boards and regulators
  3. Explore principles that lead to developments of protocols for clinical trials
Assessments
  • Continuous Assessment (100%)
Teachers
The above information outlines module MD514: "Introduction to Research Methods for Randomized Controlled Trials" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD515: Systematic Review Methods


Semester 2 | Credits: 10

This online/blended course about research synthesis focuses on comparisons between alternative interventions. Interactive learning modules, required readings, discussion boards, tutorials, and assignments will be used to highlight rigorous systematic review methods, such as searching for potentially relevant articles, selecting primary studies using explicit, reproducible criteria, appraisal of study architecture, quantitative data synthesis and interpretation.
(Language of instruction: English)

Learning Outcomes
  1. Critically discuss the role of systematic reviews within the context of evidence generation and evidence based health care
  2. Identify the key stages of the systematic review process;
  3. Develop a review question and understand how to develop a review protocol
  4. Identify and develop appropriate search methods for identification of studies including the development of a comprehensive search strategy
  5. Critically appraise the quality of included studies using methods appropriate to included study design types
  6. Critically explore the principles of data synthesis and recognise the relevance of different methods of synthesis to different study designs
  7. Explore methods for statistical (meta-analysis) and non-statistical synthesis of data/findings
Assessments
  • Continuous Assessment (100%)
Teachers
The above information outlines module MD515: "Systematic Review Methods" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD517: Clinical Research Administration


Semester 2 | Credits: 10

The successful operation and implementation of clinical research facilities and their services require efficient administration, on a number of levels. This module focuses on a variety of critical components from the administrative viewpoint and covers financial considerations, regulatory affairs, quality standards, data management, documentation, study monitoring and implementation, ethics and collaborations. The module is delivered using a blend of didactic lectures, problem-based learning in tutorial groups and project work performed by the student. This module can be taken by students interested in aspects of the establishment, management and control of CRFs and will contribute to a deeper understanding of the core structure of such facilities.
(Language of instruction: English)

Learning Outcomes
  1. An understanding of the various elements involved in the establishment and operation of clinical research teams and associated clinical trials.
  2. An appreciation of procedures involved in the successful completion and reporting of clinical trials.
  3. Comprehension of quality systems and legal requirements in the research environment.
  4. Preparation of a clinical trial protocol and other study-associated documentation, from the managerial perspective.
  5. Appreciation for the development of data collection tools, in line with data protection regulations
Assessments
  • Continuous Assessment (80%)
  • Oral, Audio Visual or Practical Assessment (20%)
Teachers
Reading List
  1. "Designing Clinical Research" by Stephen B Hulley
    ISBN: 9781608318049.
    Publisher: Lippincott Williams & Wilkins
The above information outlines module MD517: "Clinical Research Administration" and is valid from 2023 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD518: Observational Studies & Analytical Research Methods


Semester 2 | Credits: 10

Review of observational research methods, including survey research, retrospective study, prospective cohort study, case-control design, scale development, diagnostic testing and qualitative research methods.
(Language of instruction: English)

Learning Outcomes
  1. Introduce students to the basic concepts and methods used in observational (non-experimental) studies
  2. To conduct needs assessments (e.g., prevalence of disease or order)
  3. To understand the determinants of health (e.g., association between independent/exposure variables and dependent/outcome variables in analytic research)
  4. To emphasise concepts that are essential to the conduct of epidemiologic studies including internal and external validity, random variability, bias, effect modification, causality, and generalisability.
Assessments
  • Department-based Assessment (100%)
Teachers
The above information outlines module MD518: "Observational Studies & Analytical Research Methods" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

OptionalMD1601: Biobank– Advanced Clinical Application and Clinical Testing


Semester 2 | Credits: 10

This module is designed to provide an overview of biobank processes, equipment, facilities and methodology for the purposes of clinical research. The module has been designed to provide learner with the capacity to critically evaluate the clinical environment, process and procedures in which specimens are obtained transported, stored, tested and analysed. Indicatively the module included: collection process, control protocol, storage and distribution, facilities and safety, quality management systems and data systems. This module introduces the students to a range of standardised Biobank clinical testing and outcome measures used in Clinical Research, the downstream analysis of biospecimen and how these influence correct administration, scoring and interpretation.
(Language of instruction: English)

Learning Outcomes
  1. Evaluate of the requirements of a given test protocol and thus create a robust yet user-friendly SOP for clinical sampling, identification, transportation, storage and handling.
  2. Provide a comprehensive review of process regarding specimen control and thus critically appraise relative to that that of emerging technologies and cutting edge national and international practice and report on findings.
  3. Appraise current research in the area of biobank management, and report on the importance of functional operations such as specimen collection and handling.
  4. Employ advanced clinical techniques and thus test, record, quantify and disseminate data for future analytical evaluation
  5. Apply learning relating to clinical testing to advance new areas of clinical research in a particular field
Assessments
  • Continuous Assessment (80%)
  • Department-based Assessment (20%)
Teachers
The above information outlines module MD1601: "Biobank– Advanced Clinical Application and Clinical Testing" and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.

Why Choose This Course?

Career Opportunities

Graduates of the MSc in Clinical Research are well-prepared to advance into impactful roles as principal investigators (PIs) or essential team members in the planning, management, and oversight of clinical research projects. These roles are highly sought after in diverse sectors, including academia, pharmaceutical companies, clinical research organizations (CROs), hospitals, government agencies, and independent funding bodies. 

Further career pathways include opportunities in teaching, consultancy, and advisory positions, reflecting the program’s emphasis on producing versatile professionals ready to shape the future of clinical research. 

For more information on further career paths, please see here. 

 

What makes this course unique? 

  • Tailored for Future Leaders: This program is ideal for individuals aspiring to become independent clinical investigators or clinical research professionals leading research teams. Its flexible structure accommodates working professionals, offering part-time study options alongside full-time employment. 
  • Expert-Led Learning: Delivered by experienced senior researchers, academics, and healthcare professionals from the University of Galway and Saolta University Health Care Group, the program combines face-to-face and online learning for a dynamic educational experience. 
  • Diverse Career Pathways: Graduates are equipped to thrive in a wide range of roles, reflecting the growing importance of clinical research. Career opportunities span universities, the pharmaceutical industry, clinical research organizations, hospitals, government bodies, and independent funding agencies. Additional avenues include roles in teaching, consulting, and advisory capacities. 

Who’s Suited to This Course

Learning Outcomes

Transferable Skills Employers Value

Work Placement

Study Abroad

Related Student Organisations

Course Fees

Fees: EU

€9,390 p.a. full-time; €5,640 p.a. part-time (including levy) 2025/26

Fees: Tuition

€9,250 p.a. full-time; €5,500 p.a. part-time 2025/26

Fees: Student levy

€140 p.a. 2025/26

Fees: Non EU

€19,500 p.a. (€19,640 including levy) 2025/26

For 25/26 entrants, where the course duration is greater than 1 year, there is an inflationary increase approved of 3.4% per annum for continuing years fees.

Postgraduate students in receipt of a SUSI grant – please note an F4 grant is where SUSI will pay €4,000 towards your tuition (2025/26).  You will be liable for the remainder of the total fee.  A P1 grant is where SUSI will pay tuition up to a maximum of €6,270. SUSI will not cover the student levy of €140.

Note to non-EU students: learn about the 24-month Stayback Visa here

 

Find out More

For general queries, email: 

clinicalresearch@universityofgalway.ie 

Dr Sonja Khan 
Course Director, Lecturer & Head of Education at the Institute for Clinical Trials 
Institute for Clinical Trials, Clinical Research Facility,  
University of Galway 
E:sonja.khan@universityofgalway.ie 
 


Dr Johannes

Dr Johannes B. Letshwiti |   Consultant Neonatologist

I have a special interest in quality improvement (QI) projects and this is the course I had been looking for as a clinical educator. I wasn't sure at the start whether the course would be able be a good fit for those interested in QI, an important part of modern clinical practice. This course provides you with the right tools to critique journal articles, to interpret results, to set up research and QI projects, and to teach trainees on how to present research articles. It gives you basic and in-depth look at research methodology. The course is delivered in the most efficient way for those doing the course either in part-time or full time capacity. There is huge support from the instructors throughout the course. The course is delivered online with some face-to-face lectures. The latter is important as it provides tutorial rather than just lectures. There is an excellent mix of core and optional modules. The optional modules are tailored to suit your area of interest or expertise. I am in a better place right now as this course has consolidated what most health professionals do not get during their training: research methodology, an essential education piece for all clinicians.
in Connect with Dr Johannes
Chiaw

Chiaw Woon Teh |   Research Associate

Clinical research is a competitive and growing field. Being a clinical research professional, a strong academic/medical background isn’t sufficient to conduct good quality clinical research. Some significant research skills and knowledge are essential for competence in conducting research and this is the main reason I started MSc Clinical Research with NUI Galway. It is a comprehensive programme with experienced, dedicated and outstanding lecturers which includes clinicians, regulatory specialists and clinical trial specialists. It gives a great overview of clinical research with the concepts, research ethics and guidelines. This course enhances my skills in information seeking, communicating, methodological skills and data analysis. I was lucky to be offered a placement in the oncology department. It was an eye-opener experience which allowed me to have hands-on experience in the clinical trials. This course has changed my career path from a clinical pharmacist to a clinical research associate and I am glad that I made this decision.
in Connect with Chiaw
Kai

Kai Meen Chen |   Research Associate

This course provides essential knowledge and skills in clinical research areas if you are planning to pursue this field. The teaching method is an adaptive learning platform that included both online & classroom methods. The lecturers in this course are experienced & knowledgeable, they provide full support and guidance. During my academic year, I was honoured to receive the Advanced Therapies Cancer Group Scholarship in Clinical Research Facility Galway (CRFG). This placement allowed me to gain hands-on experience in clinical trials, especially in Haematology and Oncology trials. In the CRFG, I worked as a data manager at the site to complete the patient data in the database, maintain the site file and handle the monitoring visit. This working experience was invaluable and helped me understand the significance of these activities in a clinical trial. I highly recommend this course to those planning to work in clinical research, which would equip you with the basic knowledge to start your career in the academic research or pharma industry. I have no regret studying abroad for this course which is a plus for me to progress to the next level as a project manager.
in Connect with Kai
Aditya

Aditya Kodumagulla |   Pharm D

MSc. in Clinical Research program have equipped me with good Clinical and essential skills that are most needed if you are willing to start a clinical research industry career. The compulsory and optional modules are designed to complete with great flexibility and provide the basic concept with adequate staff support. My journey to Ireland started with my interest in clinical trials and Medical devices to explore good research career opportunities. However, I was fortunate enough to receive the HRB - Fellowship, which has exposed me to many practical aspects and various clinical and non-clinical pieces of training, that have helped me gain essential skills. Moreover, my student life at NUIG was amazingly packed in attending social, sports and career events which gave me enough exposure, confidence and skill to unleash my potential and supported me to create excellent research possibilities for my upcoming career.
in Connect with Aditya
Alice

Alice Power |   Quality & Regulatory Affairs Manager

The MSc. in Clinical Research was an overall excellent experience. I gained a thorough understanding of all  aspects to clinical research and since my graduation this has been beneficial to the progression of my career in research administration and management roles. The module choices offered, through both online and classroom learning, were wide enough to allow for selection on the components you might be more interested in while having optimum required core modules. Engagement, support and insight from experienced course lecturers was always available.  I have to say that completion of this MSc. has stood me very well and would highly recommend to anyone considering a clinical research management/administration future.
in Connect with Alice
Dr. Martin

Dr. Martin O'Halloran |   Techrete Snr Lecturer; Dir, Translational Medical Device Lab

In recent decades, the medical devices sector has become an ever-increasing part of the West of Ireland’s economic landscape. The growth of the sector has been supported by academic initiatives like BioInnovate, CURAM and the HRB’s Clinical Research Facility in Galway (CRFG). The Masters in Clinical Research delivered by the CRFG trains medical devices researchers on the fundamentals of designing, implementing and analysing a clinical trial. Uniquely, since the material is delivered by CRF staff themselves, the course also addresses the practical challenges of clinical research. The course content is very carefully considered and is both challenging and engaging. I couldn’t recommend the course highly enough and would consider such training a must for those engaging in medical device trials.
in Connect with Dr. Martin
Dr. Shubham

Dr. Shubham Atal |   MD, MSc

Coming from an academic–research background in medicine/pharmacology, the MSc in Clinical Research was a perfect fit for me in terms of its content, exposure and duration. It aims at facilitating a career progression into various roles in the different domains of clinical research. The availability of compulsory and elective additional modules offers great flexibility and perspective. Moreover, there were opportunities in form of part time paid internships / jobs and volunteer research assistantships to gain hands on experience in clinical research activities in the CRFG. This master’s programme is a great platform for anyone looking to launch or further a career in healthcare research in industry or academia. It helped me greatly to transition into working for a top national institute of medicine in my country as an academic actively involved in clinical research.
in Connect with Dr. Shubham
John

John O'Dea |   CEO, Crospon

With the increasing level of translational research and novel medical device design taking place in Ireland, there is a strong need to increase number of trained clinical researchers both within academia and industry. This course has been of great benefit to me in building skills in terms of RCT design and biostatistics in a formal structured manner. The various modes of learning and lecture scheduling have made this a course capable of being managed in the context of a heavy work schedule.
in Connect with John
Colm

Colm Mc Elwain |   MPharm MPSI

This course has a variety of optional modules, ranging from database development to project management, that gave me great flexibility in how I wanted to steer my own learning experience. The teaching methods used in these modules are flexible, which allows the content to be very student orientated and accessible. I was fortunate to get a place on a research fellowship in HRB’s Clinical Research Facility in Galway (CRFG). This placement was invaluable in allowing me to experience all elements of clinical research in a practical manner. In the CRFG, I worked in database management, quality assurance, quality control and project management on a variety of clinical studies. I was lucky enough to get some great advice from experienced colleagues while I was here. I would recommend the MSc. in Clinical Research to anyone who would like to utilise their skills in the world of clinical research, even if your background isn’t from a clinical setting. The course has an excellent support network and great lecturers that are happy to provide guidance and advice to students.
Shereen

Shereen Esmael |   BCPS,MSc.,Clinical Research Assistant

I started the course hoping to achieve something extra to aid my main field of Pharmacology, but I finished the course with a decision to shift my career to Clinical Research completely at an age where I should be settling with what I've already got going on. The MSc. in Clinical Research is a very well-organised course that boasts the complete package in terms of teaching all the vital aspects of clinical research, building valuable practical experience, and having suitable schedules for graduate students coming from almost any background, mine of course being Pharmacology. The course also offers a diverse selection of interesting optional modules, in addition to the required modules, that provide a wide range of exciting possibilities for your very own unique experience. I was very fortunate to earn a research scholarship in the CRFG, which proved priceless in getting me prepared for my current clinical research job after the course. I would definitely recommend the MSc. in Clinical Research to anyone hoping to pursue a career as a clinical researcher
in Connect with Shereen
Dr Yogesh

Dr Yogesh Acharya |   MD, MSc, FAcadMEd, AFAMEE

Clinical research has become an integral part of modern medicine. The impact of research in the healthcare setting lies beyond individual patients. As science continues to evolve, there is an overwhelming need for evidence-based medicine. MSc in Clinical Research at the National University of Ireland Galway provides a suitable platform for physician and healthcare staff to build a clinical research career. Dedicated faculty members consist of academia, clinicians and industry experts, who offer a practical learning experience. The problem-based active teaching and learning environment addresses the challenges in clinical research and equips students with the knowledge, attitude and competence to excel. As a recent alumnus, I highly recommend this course to those who want to build a clinical research career or consolidate their research aptitude.
in Connect with Dr Yogesh

Celia

Celia Thomas |   Clinical Research Facility at University Hospital Galway

I am delighted to share my experience in the MSc Clinical Research program at the University of Galway - a decision that has profoundly shaped my academic and professional journey. As a Pharmacy graduate, I was eager to make a leap into clinical research, and this program has been nothing short of a game-changer. From the very first day, I was struck by the vibrant energy of both the faculty and my fellow students. The curriculum is a perfect blend of theoretical insights and practical applications, ensuring that we are not just absorbing information but actively engaging with it. The emphasis on hands-on learning through workshops and real-world scenarios made a significant difference in my understanding of the field. The modules on biostatistics and health research methodologies were particularly impactful for me. They sharpened my analytical skills and ignited a genuine passion for the complexities of clinical trials. I found myself excited to analyse data and design studies, which is something I never thought I’d say. Now, as a research assistant at the Clinical Research Facility at University Hospital Galway, I feel empowered and ready to face the challenges of the field.
Ha

Ha Vu |   Research Assistant – HRB-CRFG

Before moving to Ireland, I had a few years of experience in regulatory affairs, focusing on pharmaceutical products and clinical research. I decided to join the MSc in Clinical Research to deepen my ethics-related knowledge and broaden my understanding of other aspects like study management. This course covered clinical research on a large scale, both practically and methodologically. The Clinical Trial Fellowship offered me a valuable opportunity to engage in real-world research activities, including data management and radiotherapy clinical trials. All the lectures and hands-on practice helped me obtain a more comprehensive perspective to pursue my career in clinical research.
Kishor

Kishor Shirsat , B |   Pharmacy Clinical Research Associate University of Galway

Pursuing an MSc in Clinical Research at the University of Galway allowed me to deepen my expertise in this competitive and ever-evolving field. A highlight of the program was gaining practical experience with the Clinical Research Development Office (CRDO), which enhanced my understanding of research methodologies and regulatory requirements. My thesis on patient and public involvement (PPI), guided by Dr. Sonja Khan, emphasized real-world applications and critical analysis. The program’s rigorous curriculum and hands-on learning, supported by experienced faculty, equipped me with the skills to lead research projects focused on patient outcomes and scientific integrity, positioning me to contribute meaningfully to healthcare innovation.

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