ANNUAL REVIEW master Final3a - St Vincent's University Hospital

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St. Vincent’s Healthcare Group Limited - Annual Review 2007 Ethics and Medical Research Committee The St. Vincent’s Healthcare Group Ltd., (SVHG) Ethics and Medical Research Committee (EMRC) operated as a designated recognised ethics committee acting for the whole state in compliance with the EU directive entitled: “European Communities Clinical Trials on Medicinal Products for Human Use”(Regulations 2004). In September 2007, the Department of Health & Children extended our recognition as a designated committee for a period of one year. Following the implementation of the EU directive (2004) the purpose of which was to harmonise and standardise approval for clinical trials by regulatory authorities and ethics committees across all EU member states. The revised document entitled “Guidance on the application for recognised ethics committee opinion and the ethical review of clinical trials on medicinal products for human use” was issued in July 2007. It is a requirement that each clinical trial must obtain one single ethics committee opinion for the conduct of the trial within the state in keeping with Directive. Committee Throughout the year there were a number of changes in committee membership and new members were duly appointed. Dr. Brian Kirby was appointed Chairman of the committee in September 2007 following the completion of Professor Douglas Veale’s three year term of office. Meetings There were a total of 11 Committee Meetings held from 1st January 2007 to 31st January 2008 Clinical Trials Reviewed Number of New Clinical Trial Proposals Considered: 14 Number Issued a Favourable Opinion: 14 Total 14 SVHG EMRC are the responsible Ethics Committee for the following: Pharmaceutical Sponsored Trials 24 Investigator Led Trials 11 Pharmaceutical/Investigator Led, External Sites only 11 Total 46 Return to Contents 8
Research Studies Total Research Studies Reviewed 99 Total Approved 99 Amendments Total Number of Clinical Trial Amendments Reviewed and Approved 60 Quarterly/Annual/Termination Reports Total Number of Reports Reviewed and Noted 110 Copies of all application documents are available electronically and in hard copy from Ms Joan McDonnell/Ms Anna Brennan, Ethics Office, ext: 4117 (joan.mcdonnell@ucd.ie). (anna.brennan@ucd.ie). Return to Contents 9
Page 3 and 4: Review 2007 St. Vincent’s Healthc
Page 5 and 6: St. Vincent’s Healthcare Group Li
Page 7: Celebrations • There was a great
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Page 30 and 31: The bioinformatics group moved with
Page 46 and 47: In collaboration with Prof. Kingsto
Page 48 and 49: Education & Research Poster Present
Page 56 and 57: Education & Research Pharmaceutical
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St. Vincent’s Healthcare Group Li
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Prestigious Invitations/Honours for
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74 Quality
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St. Michael’s Hospital Nursing Th
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St. Vincent's Private Hospital Cons
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St. Vincent's Private Hospital A mo
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St. Vincent's Private Hospital Nurs
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St. Vincent's Private Hospital Nati
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St. Vincent's Private Hospital Supp
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St. Vincent's Private Hospital Trai
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St. Vincent's Private Hospital Occu
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St. Vincent's Private Hospital The
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Report from the Director of Operati
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Department - Chaplaincy/Pastoral Ca
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Department - Library & Information
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Allied Health Professionals - Occup
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Allied Health Professionals - Physi
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Allied Health Professionals - Depar
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Report from the Director of Nursing
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Hospital Hygiene Services St. Vince
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Department of Medical Oncology inco
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Department - Medicine at UCD. This
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Department of Cardiology The demand
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Papers Published & Accepted Ponikow
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Department - Medicine Department of
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Department of Endocrinology & Diabe
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Department of Endocrinology & Diabe
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Lios Aoibhinn Cancer Support Centre
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Issues continuing to challenge the
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Department of Nephrology Staff Cons
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Service Developments Neurology in t
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Department of Clinical Neurophysiol
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Department of Respiratory Medicine
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Report from the Professor of Surger
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Department - Surgery Department of
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Department - Operating Theatre Deco
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Department - Surgery Department Ort
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Department - Plastic Surgery Dr Law
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Cancer remains a significant focus
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Department - Urology Consults • 3
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Department of Vascular Surgery Pres
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Reports Medical and Surgical Gastro
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Department - Radiology Radiography
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Department of Old Age Psychiatry Th
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Report from the General Services Ma
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General Services The HACCP system i
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General Services necessitated in ex
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Reports Report from the Human Resou
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ICT Department Staffing In 2007 we
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Purchasing & Procurement Department
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St. Vincent’s University Hospital
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ANNUAL REVIEW master Final3a - St Vincent's University Hospital

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