Syllabus for Clinical Trial Methodology
Klinisk prövningsmetodik
A revised version of the syllabus is available.
Syllabus
- 7.5 credits
- Course code: 3FB030
- Education cycle: Second cycle
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Main field(s) of study and in-depth level:
Pharmaceutical Sciences A1N,
Drug Discovery and Development A1N
Explanation of codes
The code indicates the education cycle and in-depth level of the course in relation to other courses within the same main field of study according to the requirements for general degrees:
First cycle
- G1N: has only upper-secondary level entry requirements
- G1F: has less than 60 credits in first-cycle course/s as entry requirements
- G1E: contains specially designed degree project for Higher Education Diploma
- G2F: has at least 60 credits in first-cycle course/s as entry requirements
- G2E: has at least 60 credits in first-cycle course/s as entry requirements, contains degree project for Bachelor of Arts/Bachelor of Science
- GXX: in-depth level of the course cannot be classified
Second cycle
- A1N: has only first-cycle course/s as entry requirements
- A1F: has second-cycle course/s as entry requirements
- A1E: contains degree project for Master of Arts/Master of Science (60 credits)
- A2E: contains degree project for Master of Arts/Master of Science (120 credits)
- AXX: in-depth level of the course cannot be classified
- Grading system: Fail (U), Pass (G), Pass with distinction (VG)
- Established: 2018-11-15
- Established by:
- Revised: 2019-04-25
- Revised by: The Educational Board of Pharmacy
- Applies from: Autumn 2019
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Entry requirements:
Master of Science Programme in Pharmacy: at least 150 credits within the programme, semester 1-7, including passed courses in pharmacokinetics, pharmacology and physiology
Bachelor of Science Programme in Pharmacy: at least 120 credits within the programme, semester 1-5, including passed courses in pharmacokinetics, pharmacology and physiology
Master's Programme in Drug Discovery and Development: passed course in pharmacokinetics
Master's Programme in Pharmaceutical Modelling: passed course in pharmacokinetics
Acceptance to a single subject course requires basic qualification according to the higher education ordinance (120 credits), and knowledge corresponding to at least 60 credits within the subject Pharmacy, Pharmaceutical science or Pharmaceutical bioscience, including Pharmacokinetics 7.5 credits, and knowledge corresponding to Physiology 6 credits and Pharmacology 7.5 credits. Proficiency in English equivalent to the general entry requirements for first-cycle (Bachelor's level) studies.
- Responsible department: Department of Pharmacy
Syllabus Revisions
- Latest syllabus (applies from Autumn 2023)
- Previous syllabus (applies from Autumn 2019)
- Previous syllabus (applies from Spring 2019, version 2)
- Previous syllabus (applies from Spring 2019, version 1)
Reading list
Reading list
Applies from: Autumn 2019
Some titles may be available electronically through the University library.
Mandatory literature
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WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
World Medical Association,
https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/
Mandatory
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Guideline for good clinical practice E6 (R1)
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, 1996
Mandatory
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ICH Topic E6: Guideline for Good Clinical Practice
EMA,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
Mandatory
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ICH Topic E8: General Considerations for Clinical Trials
EMA,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdf
Mandatory
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ICH Topic E3: Structure and Content och Clinical Study Reports
EMA,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002832.pdf
Mandatory
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ICH topic E9: Statistical Principles for Clinical Trials
EMA,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf
Mandatory
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ICH topic E10: Choice of Control Group and Related Issues in Clinical Trials
EMA,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf
Mandatory
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Pharmacokinetics studies in man
European Medicines Agency, 1988
https://www.ema.europa.eu/documents/scientific-guideline/pharmacokinetic-studies-man_en.pdf
Mandatory
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ICH Topic E4: Dose-Response Information to Support Drug Registration
EMA,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002834.pdf
Mandatory
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CPMP/EWP/908/99: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS
EMA, European Medicines Agency,
http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf
Mandatory
Recommended literature
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REGULATION No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC.
EU,
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DIRECTIVE 2001/20/E, laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
EU,
https://ec.europa.eu/health/human-use/clinical-trials/directive_en
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2011/C 172/01: Communication from the Commission - Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3)
EU,
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497948126522&uri=CELEX:52011XC0611(01)
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Consort 2010 Checklist, Explanations and Elaboration document
The CONSORT Group, 2010
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CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
BMJ, 2010
Artikel med checklista, förklaringar och bakgrund (open access)
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Pocock, Stuart J.
Clinical trials : a practical approach
Chichester: Wiley, cop. 1983
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Fundamentals of Clinical Trials
Friedman, Lawrence M.;
Furberg, Curt D.;
DeMets, David L.;
Reboussin, David M.;
Granger, Christopher B.
5th ed. 2015.: Cham: Springer International Publishing, 2015.
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EMA/CPMP/EWP/1776/99 Rev. 1: Guideline on Missing Data in Confirmatory Clinical Trials
EMA, European Medicines Agency,
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf
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CPMP/EWP/482/99: POINTS TO CONSIDER ON SWITCHING BETWEEN SUPERIORITY AND NON-INFERIORITY
EMA, European Medicines Agency,
http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf