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Clinical Research

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									Clinical Research
Edinburgh Napier University has a track record of providing innovative programmes of under and
post graduate qualifications in clinical research to an international audience. The range of
programmes offered have been developed in collaboration with prominent Healthcare and
Pharmaceutical partners. Taught by experts in the field, the programmes adhere to the strictest
EU/FDA regulations and are externally validated by other UK Higher Educational Institutions, Clinical
Research Organisations and the Institute of Clinical Research.

To date these modules have been delivered to a range of clinical research professionals across the
globe. . They have been delivered using a flexible online approaches including face-to-face sessions
in Edinburgh, Singapore and Hong Kong as required. We have an excellent success rate in each of
our programmes and now boast in excess of 100 graduates all over the world.

We offer short CPD courses in Good Clinical Practice and Under/post graduate programmes in
Clinical Research that can lead to awards at degree and post graduate level.

Some of our programmes are delivered jointly with the Institute of Clinical Research
(http://www.icr-global.org/ ). The Institute of Clinical Research (ICR) was founded in 1978 as ACRPI
(The Association of Clinical Research for the Pharmaceutical Industry). In 2000 it changed its status
to become the Institute of Clinical Research and is well established as the largest professional clinical
research body in Europe and India. The primary focus of these courses is for Research Nurses and
Clinical Research Associates, but other groups can also be accommodated.

The modular format allows students to choose whether to study this topic at either under or post
graduate level. They could contribute to a flexibly managed Undergraduate degree or Masters
degree in Clinical Research.

Programme aims

       To provide students with knowledge and skills that will enable them to respond effectively in
        a rapidly changing health arena that is strongly influenced by healthcare trends and local,
        national and international legislation.

       To support and challenge students in the development of their knowledge and skills to
        enable them to enter and / or continue more effectively in the professional practice of
        clinical research.

       To encourage students to utilise their skills and knowledge to influence the developing field
        of clinical research

       To provide students with the opportunity critically explore the complexities of conducting
        clinical research in the current healthcare and legislative environment


Modules Delivered
Clinical Research - Theory
This module relates to the theoretical principles that influence clinical research and the design of
clinical research/trials. This will provide you with a sound understanding of how the design of
research/clinical trials can underpin the development of research. Completion of this module will
enhance your ability to undertake your role and assist in your development within the field of
Clinical Research.
The module includes an exploration of research paradigms and research design; phases of clinical
trials; statistics in clinical research; theories and principles of ethics; investigation of ethics in
research; exploration of key characteristics of quantitative research and critical appraisal of
evidence.

Clinical Research - Legislation and Regulation
This module will explore the regulatory and legislative infrastructure that effects and influences
clinical research. International and National examples will be used to explore how this area can
directly impact on the design, conduct and reporting of clinical research. Completion of this module
will enhance your ability to undertake your role and assist in your development within the field of
Clinical Research.
The module includes an exploration Good Clinical Practice; EU Clinical Trials Directive; Research
Governance; Regulatory authorities; Ethics Committees/Institutional Review Boards; local approval
and inspections/audits.

Clinical Research - Practice
This module will provide you with the knowledge and skills to be able to interpret the practical
aspects of the professional roles in clinical research and to apply this knowledge to enhance your
ability to improve your practice. Completion of this module will enhance your ability to undertake
your role and assist in your development within the field of Clinical Research.
Content delivered to students face to face in this module includes:
Critical reflection; monitoring and audit of clinical trials; local trial responsibilities; standard
operating procedures; ethical and managerial approval; data management; Informed consent; drug
accountability; communications skills and exploration of issues related to professional roles in
clinical research.
The online element of the delivery includes searching, locating and reviewing the literature, the
reflective cycle, ethical dilemmas and informed consent.

On completion of these modules, students can continue with further study to attain a Degree, or
Masters in Clinical Research by undertaking other modules from the health and biomedical area.


Continual Personal Development course

In addition to the Degree and Masters programmes Edinburgh Napier University also offer a short
CPD course providing and annual Good Clinical Practice update for professionals working in this field.
This is based GCP guidelines which are an international standard for the planning, implementation
and analysis of clinical research data. This is delivered and assessed on-line allows maximum
flexibility for professionals undertaking the course.

All topics incorporated into GCP are contained within the course and including:

       Informed consent
       Roles and responsibilities

       Ethical approval

       Collection and monitoring of data

       Adverse drug reactions

       Role of regulatory authorities



The course is aimed at a number of professionals associated with the practical implementation of
clinical research, including: Investigators, Trials co-ordinators, Clinical Research Nurses, Clinical
Research Associates and data managers.




Edinburgh Napier Staff

Gordon Hill MSc, PGCE, BA, RGN (Programme Leader)

Gordon is a Lecturer in Clinical research in the Centre for Well-being and Healthcare. He is the
Programme leader for the Post Graduate Certificate in Clinical Research Associate training, Under and
Postgraduate Certificates in clinical Research. He took up this post in 2006 having previously held a
post of Associate Nurse Manager in the Clinical Research Facility in Edinburgh and a held a number of
research posts prior to that. Gordon is also the Chair of the Scottish research Nurse and Co-
ordinator’s Network www.srncn.scot.nhs.uk

Dr Lynn Kilbride PhD, MSc, PGCE, BA (hons), RGN (Lead for Clinical Research)

Lynn undertakes an active teaching and research role as a Reader in the SNMSC. She is chief
investigator in a number of research and knowledge transfer projects in the area of diabetes and
neurosciences. Previously Lynn undertook a research nurse role and this experience, combined with
her chief investigator role, has provided her with the knowledge and expertise to actively contribute
to the clinical research education that is offered within Edinburgh Napier University.


Janyne Afseth MSc, BSN, RGN (Lecturer Clinical Research)

Janyne is a lecturer in the School of Nursing Midwifery and Social Care, and is a lecturer on the Post
Graduate Certificate in Clinical Research Training. Before this post Janyne contributed to the
programme for two years whilst employed as the Research Network Manager for cancer research in
the South East of Scotland. She has also been on the steering group for Clinical Research Training
Scotland, who provide research governance training for staff within the health service as well as the
Scottish representative for cancer research training for research staff in the UK.



For more information please contact :
Gordon Hill g.hill@napier.ac.uk (0131 455 5658) or Lynn Kilbride l.kilbride@napier.ac.uk (0131 455
5654).

								
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