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: The Educational Board of Pharmacy
- Applies from: Spring 2019
- Entry requirements:
- 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: Spring 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