1. Michelle Donnison
Senior Pharmacy Technician

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BTEC National Diploma in Health Studies (2004)
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NVQ Level 3 in Pharmacy Services (2007)
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BSc (Hons) Medical Physiology (2011)
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Started working at York Hospital (2011)
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Postgraduate Certificate in Health Research (in
progress)

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Commercial (pharmaceutical companies)
Non-commercial / Academic (NHS,
charities, universities)
Observational studies
• Medical Device studies
• Drug Studies (CTIMP)
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4. •
Phase I – test the safety of a new drug in healthy
volunteers. Testing safety and establishing a safe dose
range (less than 100 people)
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Phase II – test the new drug on a larger group of people
who may benefit from the treatment (100 to 300 people)
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Phase III – test the new drug in larger groups of ill people.
Compare a new drug against an existing treatment or a
placebo (1000 to 3000 people)
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Phase IV – occur once new medicines have been given a
marketing licence. Investigate safety, side effects and
effectiveness of the drug (more than 3000 people)

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Sponsors
Doctors (Principal Investigators)
Research Nurses
Research & Development team
Other departments within Pharmacy
University of York (phase I studies)
Regulatory bodies (e.g. MHRA)

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Oncology
Haematology
Cardiology
Rheumatology
Stroke
Anaesthetics
Ophthalmology
Genitourinary Medicine
Dermatology
Renal
Neurological

7. Setting up clinical trials
• Ordering Investigational Medicinal Products (IMPs)
• Receiving IMP
• Dispensing
• Drug accountability
• Returning/destroying IMP
• Temperature monitoring
• Hosting monitoring visits
• Trial initiation meetings
• Writing standard operating procedures
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8. •
Open label – everyone knows what treatment
the patient is receiving
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Single blind – the patient does not know what
treatment they are receiving
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Double blind – everyone involved does not
know which treatment the patient has been
randomised to receive

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Trust-sponsored study
Pharmacy only unblinded team
Published in British Journal of Anaesthesia in
2013
Concluded “Goal-directed fluid therapy is
possible with either crystalloid or HES. There
is no evidence of a benefit in using HES over
crystalloid, despite its use resulting in a lower
24 hour fluid balance.”

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Pharmacy Assistant
Clinical Trial Assistant
Clinical Research Associate
Research Nurse
Principal Investigator
Trial co-ordinator
Trial administrator
Data management