ulbiro

Neuer Studiengang Master of Science in Clinical Research Administration

4 Beiträge in diesem Thema

Nachdem im Jahr 2000 mit dem von mir absolvierten MSc in IT der erste Online-Studiengang in der Zusammenarbeit zwischen der University of Liverpool und Laureate Online Education gestartet wurde, gesellt sich jetzt der neue MSc in Clinical Research Administration als fünfter eigenständiger Studiengang hinzu.

Die Beschreibung (http://www.uol.ohecampus.com/programmes/msc_cra.phtml):

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

Für die ersten Teilnehmer wird ein 50%-Rabatt angeboten, wenn sie sich an der Auswertung und Verbesserung des neuen Studiums beteiligen:

The University of Liverpool and its e-Learning partner Laureate Education are proud to announce the launch of the fully online MSc in Clinical Research Administration. The first intake of students will be on June 19th 2008. To celebrate the launch of this new programme, we are offering a 50% scholarship on tuition fees to students who enrol into the “Student Advisory Board” for this programme. The primary purpose of the Student Advisory Board is to allow students to provide feedback on the curriculum & modules, and to provide insights on their needs to Laureate Education so we can ensure that this programme remains current with market needs.

To qualify for the “Student Advisory Board” scholarship, please find below the terms and conditions that apply to this arrangement. The following rules apply:

Students must enrol in the scholarship by agreeing to the enclosed Terms & Conditions and returning the completed form to Laureate Education

Students will need to start their studies on June 19th 2008

Students will commit a total of 20 hours of their time for Student Advisory Board meetings over the entire course of the programme (in addition to the time required for their studies) Student Advisory Board meetings will be organised by Laureate and could take the form of online surveys, one-on-one interviews & group discussions. Students who enrol in this scholarship should expect to be solicited by Laureate approximately 2 hours per module

Students who enrol in the programme but cannot meet the time commitments of the Student Advisory Board will lose the scholarship

Zur Information: das student advisory board ist ein wichtiges Instrumentarium (das von Seiten der Studentenschaft initiiert wurde) zur Qualitätskontrolle und -verbesserung der Onlinestudiengänge, das ansonsten von den Studenten im ureigensten Interesse auch kostenlos wahrgenommen wird.

Dieses Angebot zeigt, als wie wertvoll Laureate mittlerweile dieses Gremium einschätzt.

ulbiro


Absolvent Online-Studium zum

Master of Science in Information Technology

an der University of Liverpool

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Hi,

Ich finde es sieht super interessant aus was dort angeboten wird. Ich bin am überlegen ob ich es studiere oder nicht :confused:. Gibt es jemanden, der das mormentan studiert? Erfahrungsberichte usw.

Danke für's feedback..

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Hi Xray,

leider kenne ich niemanden der aktuell Studierenden, aber ich habe diesen Bericht über das Studium mit einigen Zitaten von Studenten gefunden:

http://medinfoweb.de/apps/webeditor//files/20081126_clinical_research_report.pdf

Den Übersetzer sollte man ....:thumbdown:

Gruß,

ulbiro


Absolvent Online-Studium zum

Master of Science in Information Technology

an der University of Liverpool

Diesen Beitrag teilen


Link zum Beitrag
Auf anderen Seiten teilen

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