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Programme Outline
Programme
Structure
Module
Abstracts
Prerequisites
Tuition Fees
Aims of the programme
The MSc in Clinical Research Administration aims to meet the needs of professionals with a background in health related disciplines who wish to broaden or begin a career in clinical research administration.
The programme has been developed by some of the world’s leading experts in this field under the auspices of the University of Liverpool’s prestigious Faculty of Medicine, which incorporates a highly regarded clinical research unit and includes four Nobel laureates among its former members. The MSc provides an ideal foundation for a professional role in commercial and institutional organisations in a wide range of medical-related sectors.
A unique interactive learning approach, incorporating rich media and a dynamic online classroom, enables you to engage fully with a range of important subject areas. Modules cover the ethical, legal and regulatory considerations that affect clinical trials, the essentials of Good Clinical Practice, the design and conduct of the clinical protocol, biostatistics, data management, product development and health economics. You will complete your degree with an original dissertation and be well versed in the principles of risk assessment and management, demonstrate an understanding of economic evaluation and appreciate the factors that affect subject participation in clinical research.
You will emerge equipped with all the tools you need for this modern discipline to plan, coordinate and conduct a complete clinical trial, from pre-study to close-out.
Your enhanced skills in communication, teamwork, information technology and statistics will further prepare you for a career in this expanding global industry.
Learning Outcomes
By the end of the programme you will be able to critique research strategies, appraise published clinical research and interpret new research. You will have a clear understanding of roles and responsibilities within the clinical research enterprise and an awareness of ethical, legal, and regulatory considerations. You will have mastered the essentials of Good Clinical Practice (GCP) and be able to plan, implement, monitor and manage a clinical trial from pre-study activities to study close-out. You will apply the principles of risk assessment and management in clinical trials monitoring, including reporting of adverse events. Furthermore, you will demonstrate an understanding of economic evaluation and be able to identify relevant global trends and issues. Your enhanced skills in communication, teamwork, information technology and statistics will further prepare you for positions in a wide range of medical-related sectors.
Programme Structure
The programme comprises eight modules, culminating in a dissertation. Each module lasts eight weeks. You take one module at a time in order to study a specific subject in depth without distractions.
Modules
- Introduction to Clinical Research
- Ethical, Legal and Regulatory Considerations in Clinical Investigations
- Design and Conduct of the Clinical Protocol
- Good Clinical Practice in Managing and Monitoring Clinical Trials
- Biostatistics
- Information and Data Management
- Product Development in the Pharmaceutical, Biotech and Medical Device Industries
- Health Economics and Financial Management in Clinical Research Administration
Module Descriptions
Introduction to Clinical Research
Aim: To provide an in-depth and comprehensive understanding of the principles and practice of clinical research
This module provides a thorough understanding of the history and evolution of clinical research, including examples of landmark studies and controversies. You will examine the context in which research is undertaken; types of studies; objectives and outcomes; definition and phases of protocols; and the roles and responsibilities of the clinical research team and study sponsors. You will also acquire an understanding of key medical terminology.
Ethical, Legal and Regulatory Considerations in Clinical Investigations
Aim: To provide an in-depth understanding of the ethical, legal and regulatory dimensions of systematic knowledge of the socially responsible conduct of clinical investigations
This module offers an in-depth examination of ethical, legal and regulatory requirements and their interplay in clinical research. Subjects include recruitment and protection of subjects; diversity and vulnerable populations; informed consent; privacy/confidentiality; the role of IRB/IECs; and reporting of serious adverse events. You will explore scientific integrity and misconduct; international research; relationships with industry; conflict of interest; intellectual property; and publications and authorship.
Good Clinical Practice in Managing and Monitoring Clinical Trials
Aim: To critically examine the requirements of good clinical practice
You will acquire a firm grounding in the tenets, history and regulatory context that inform good clinical practice (GCP) as defined by the International Conference on Harmonization (ICH, from study initiation to final reports. Topics will include standard operating procedures (SOPs),. recruitment; quality assurance; data safety monitoring boards (DSMBs); multi-centre/large-scale trials; protocol management and amendments; audits; and reporting.
Design and Conduct of the Clinical Protocol
Aim: To provide a systematic understanding and critical awareness of the requirements of the content of a clinical trial protocol
This module covers specification of research design, including methods and goals; objective and hypothesis; specification of the study population; outcome measures; reliability and validity;; randomisation; documentation requirements,. outsourcing; multi-centre trials; and sponsor contracts.
Biostatistics
Aim: To provide a systematic grounding in statistics as required by clinical research professionals
This module addresses the role of biostatistics in clinical research, including descriptive methodologies; statistical tests; and confidence intervals. You will examine basic concepts of data collection and analysis using a statistical computer package such as SPSS. The module also covers development of the Statistical Analysis Plan (SAP), preparation of the statistical report and integration in the Clinical Study Report (CSR).
Information and Data Management
Aim: To provide a critical understanding of the issues surrounding data efficiency and security in the context of clinical research
You will examine the importance of information systems and information technology in increasing efficiencies in the management of clinical research data. You will consider the application of legal and ethical principles to the development of a data collection and management plan. You will also address issues of confidentiality, security of information systems and electronic data capture (EDC).
Product Development in the Pharmaceutical, Biotech and Medical Device Industries
Aim: To provide a systematic understanding of how industry processes drugs and devices through research and development
This module examines current industry trends and issues with a focus on how clinical research is used to help bring products to market. It considers new drug and medical device applications; pre-market approvals; marketing authorisations; and post-marketing surveillance. In addition, it covers pharmacogenomics; pharmacoepidemiology; safety concerns; globalisation; drug pricing and healthcare reimbursement; product life-cycle management; outsourcing to developing countries; patent strategies; and accelerated approval.
Health Economics and Financial Management in Clinical Research Administration
Aim: To provide a comprehensive understanding of the economics of global clinical research and the ability to manage a clinical trial budget from planning to publication.
You will develop an understanding of economic evaluation and financial management in clinical research administration. This module gives special attention to issues such as resource scarcity and choice in the clinical research environment; cost/benefit considerations in study design and in evaluation of the clinical intervention; opportunity costs; quality of life considerations; valuation of research outcomes; and case studies from the National Institute of Clinical Excellence (NICE).
You will develop a systematic understanding of financial management in clinical research administration including estimating the full cost of a clinical protocol, the decision to outsource, calculation of direct clinical costs vs. research costs and institutional overhead, and developing and negotiating clinical trial budgets and payment terms with sponsors.
Dissertation
Aim
To undertake a piece of original public health research to demonstrate your mastery and integration of knowledge you have acquired during the programme.
Description
At the culmination of the programme students undertake an original, research project in an area of public health that applies the new
knowledge and experience gained during the taught programme, including your understanding of quantitative or qualitative research methods.
Prerequisites
Graduates in a health related discipline of an approved university who have not less than one year (and preferably longer) post-registration professional experience
Other health-related graduates of an approved university or other institution who have not less than two years of professional experience
Non-health-related graduates, and others who have satisfied the requirements of approved exam boards, or have satisfied the University that they are suitably qualified to undertake a postgraduate programme. They must have at least two years approved professional experience in a health related field, and either completed the final examination of an approved professional institution, or obtained some other qualification approved for this purpose by the University
In addition, applicants require a GCSE Grade C or GCE O Level pass in Mathematics and English, or an equivalent qualification.
Applicants from outside the UK will also normally be required to have passed the IELTS (International English Language Testing System) examination or TOEFL (Test of English as a Foreign Language) test before commencing the programme. The following standard is required:
an overall score of at least 6.5 for IELTS and 550-575 (paper-based), 213-232 (computer-based), 84 (Internet-based) for TOEFL
both the reading and writing elements of IELTS must be scored at least at the level of 6.5 and of the TOEFL Internet based test must be scored at least at 22. Paper based and computer based TOEFL results that are in the above overall minimum ranges will be assessed on an individual basis
the IELTS reading and writing tests taken by candidates must be the Academic Reading and Academic Writing tests. Please refer to these websites if you need to arrange a test: http://www.ielts.org/default.aspx or http://www.ets.org/toefl
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