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/Chair
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 know: - Basic principles of pharmacokinetics (PK) and the most common types of PK studies - Clinical trial methodology according to Good Clinical Practice (GCP) - Basic biostatistics, with focus on power calculations and analysis of different primary and secondary variables in clinical trials. - How to design a phase III study from a previous phase II study - Regulatory procedures at the registration of new drugs and the other roles of Regulatory affairs in clinical drug development - Basics of clinical trial monitoring - How to write a complete clinical trial protocol
The course consists of the following sections:
1 week: Introduction and ethics in clinical trials 2 weeks: Pharmacokinetics, PK/PD 1 week: Pre-clinical drug development and toxicology 2 weeks: Basic statistics for clinical trials 2 weeks: Trial methodology with applied biostatistics 1week: Registration of new drugs - Regulatory affairs 4 weeks: Clinical trials; including special areas, cardiology, endocrinology, oncology, neurology and psychiatry. 1 week: Monitoring 6 weeks: Protocol writing
The course is given as a series of lectures and seminars, but also consists of study visits, individual projects, and group assignments. Parts of the course are web-based and we use the web platforms of Uppsala University.
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 and two examiners. Each student will also act as opponent on one protocol
In order to be examined the student must have fulfilled the compulsory parts of the course. To receive a passed on the course, all compulsory parts and a passed examination are required.
Students who have not passed the examination have the right to take the examination 4 additional times (= total 5 examinations). If the student can claim special reasons, the programme committee may admit additional examination. 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)
Handbok i genomförande av en klinisk prövning : praktisk tillämpning av lagar och regler med fokus på monitering