Main field(s) of study and in-depth level:
Medical Science 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:
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.
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.
Fail (U), Pass (G)
The Educational Board of Medicine
At least 180 credits within the disciplinary domains of Medicine and Pharmacy.
This course aims to provide students with a broad and deep knowledge of most stages in a drug's development from idea to completed product. Special emphasis is placed on clinical trial methodology, where the students will learn to plan a larger clinical trial. At the end of the course the students should: - Be able to describe the basic principles of pharmacokinetics (PK) and the most common types of PK studies as well as be able to do calculations using pharmacokinetic formulas - Be able to describe clinical trial methodology according to Good Clinical Practice (GCP) - Be able to describe the basic principles of biostatistics in clinical trials and do sample size calculations - Be familiar with the regulatory procedures for the registration of new drugs and the other roles of Regulatory Affairs in clinical drug development - Be able to describe the purpose of clinical trial monitoring and be able to perform the monitoring of a clinical trial - Be able to write a complete clinical trial protocol
The course consists of the following sections:
Introduction and ethics in clinical trials Pharmacokinetics, PK/PD Pre-clinical drug development and toxicology Basic statistics for clinical trials Trial methodology with applied biostatistics Registration of new drugs - Regulatory affairs Clinical trials in various diagnostic areas Monitoring Protocol writing
The course is given as a series of lectures and seminars, but also consists of study visits, individual projects, and group assignments.
Examinations are arranged continuously as seminars or written examinations.
At the final exam, the students will write a complete clinical trial protocol and present it before a smaller group of students as well as examiners in a respondent/opponent form
Students who have not passed the examination have the right to take the examination 4 additional times (= total of 5 examinations). If the student can claim special reasons, additional examinations may be allowed. Every time the student actually sits for an examination will be counted as an examination. Submission of so-called blank examination is counted as an examination.
If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University´s disability coordinator.
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
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)