Graduate School of health and Medical Sciences

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The Fundamentals of Randomized controlled trials
Provider: Faculty of Health and Medical Sciences

Activity no.: 3346-26-00-00	There are 40 available seats
	Enrollment deadline: 24/10/2026

Date and time	24.11.2026, at: 09:00 - 26.11.2026, at: 18:00
Regular seats	40
Course fee	1,920.00 kr.
Lecturers	Tor Biering-Sørensen
ECTS credits	1.80

Contact person	Pernille Højvang Nielsen E-mail address: pehn@biomed.au.dk

Enrolment Handling/Course Organiser	PhD administration SUND E-mail address: phdkursus@sund.ku.dk

Enrolment guidelines This is a generic course. This means that the course is reserved for PhD students at the Graduate School of Health and Medical Sciences at UCPH. Anyone can apply for the course, but if you are not a PhD student at the Graduate School, you will be placed on the waiting list until enrollment deadline. After the enrollment deadline, available seats will be allocated to the waiting list. The course is free of charge for PhD students at Danish universities (except Copenhagen Business School), and for PhD students at NorDoc member faculties. All other participants must pay the course fee. Learning objectives 1. Understand core principles and practical challenges in designing and conducting randomized controlled trials. 2. Gain insight into key statistical concepts for trial planning, analysis, and interpretation. 3. Navigate ethical and regulatory considerations for trial approval and oversight. 4. Learn from real-world examples and lessons shared by experienced trialists. Content The course spans three days and combines lectures, discussions, and participant-driven sessions. The first part covers the fundamentals of randomized controlled trials, including core design principles and common challenges, and includes a masterclass on key statistical concepts for trial planning and interpretation. National and international trialists will share real-world experiences and lessons from major clinical trials, offering insight into methodological hurdles and practical solutions. Participants will present a focused 3-minute pitch of their own planned or ongoing study in the PICO format, highlighting potential challenges, with experienced trialists facilitating discussion and feedback. This day concludes with a dinner for participants, speakers, and organizers. The program closes with sessions on ethical and regulatory aspects of trial conduct, featuring perspectives from institutional review boards and regulatory authorities. Participants PhD students who are interested in, planning, or currently conducting randomized controlled trials within health sciences. Relevance to graduate programmes The course is relevant to PhD students from the following graduate programmes at the Graduate School of Health and Medical Sciences, UCPH: - All graduate programmes Language English Form Lectures, discussions, presentations. Course director Tor Biering-Sørensen, MD, MPH, MSc, PhD Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen. Head of Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte. E.mail: tor.biering-soerensen@regionh.dk / tor.biering.sorensen@alumni.harvard.edu / tobs@sund.ku.dk Teachers The faculty will include senior figures from ethical and regulatory institutional review boards, experienced national and international trialists, master statisticians, and senior researchers from the Center for Translational Cardiology and Pragmatic Randomized Trials (University of Copenhagen and Herlev & Gentofte University Hospital). • Manan Pareek - Herlev & Gentofte University Hospital • Anne Marie Reimer Jensen - Herlev & Gentofte University Hospital • Mats Lassen - Herlev & Gentofte University Hospital • Lisa Steen Duus -Herlev & Gentofte University Hospital • Niklas Dyrby Johansen - Herlev & Gentofte University Hospital • Anders Granholm - Copenhagen University Hospital, Rigshospitalet • Søren Hardt-Lindberg - Novo Nordisk, Denmark • Professor Jane Armitage – University of Oxford, United Kingdom • Professor Anders Perner, Rigshospitalet and University of Copenhagen • Mads Markersen - Danish National Center for Ethics • Karen Petersen - Danish Medicines Agency • Maria Sørensen - Danish Medicines Agency • Pernille Ask Aabo, GCP-UNIT Dates November 24-26 2026, Course location Panum Registration Please register before October 24 2026 Expected frequency Annual Seats to PhD students from other Danish universities will be allocated on a first-come, first-served basis and according to the applicable rules. Applications from other participants will be considered after the last day of enrolment.

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