Title:	Applied Clinical Research
Keywords:	Statistics Planning and programming Organisation Project Management Drugs and vaccines Medical & Clinical sciences
Country:	Germany
Institution:	Germany - Center for International Health at the Ludwig-Maximilian-Universität München
Course coordinator:	Vahuka Valiyakath
Date start:	2026-03-09
Date end:	2026-03-13
About duration and dates:	Application deadline: 4 weeks prior to first presence course day. Pre-reading materials will be distributed 2 weeks prior to course commencement.
Classification:	advanced optional
Mode of delivery:	Face to face
Course location: Teaching and Training Unit at the Division of Infectious Diseases and Tropical Medicine Address: Türkenstraße 89, 80799 Munich, Germany. In case places in the course are still available, hybrid option might be considered. or further information and registration: https://www.cih.lmu.de/applied-clinical-research
ECTS credit points:	3 ECTS credits
SIT: 90 hours SIT: ● Pre-course phase ( 2 weeks prior the f2f period): 30h pre- reading (literature readings, protocol presentation preparation) ● Face-to-face learning & Self study hours: 45h = 1 week ( Guided study & Exam prep 8 hours and 37 hours lecture) ● Post course assignment: 15h (GCP exam)
Language:	English
Description: At the end of the module the student should be able to … ● Develop a clinical trial protocol (incl. formulation of research question and primary study objectives; identifying a suitable study design; statistical considerations, etc.) ● Design a Case Report Form (CRF) to demonstrate understanding of Clinical Data Management ● Discuss the elements of the clinical trial life cycle and its management (e.g. regulatory and ethical frameworks, timelines and milestones, project execution, quality management tracking and controlling) ● Distinguish different study designs in clinical research (observational, e.g. descriptive, cross-sectional etc., vs. experimental studies, e.g. trial) ● Translate clinical trial findings (e.g. for policy development)
Assessment Procedures: ● A 1.5-hour multiple-choice (MC) test will be held on the final day of the face-to-face course. Grades will be awarded from A to F. This is the summative assessment and determines the final course grade. ● Students who fail the MC test will be required to complete a 2,000-word essay on a topic assigned by the facilitators. The highest grade that can be awarded for the essay is Grade D (Pass). ● Students must complete a study protocol and design a Case Report Form (CRF) and present these during the course week. This component is pass/fail only and is not graded. ● The presentation consists of a 15-minute presentation per student group, followed by discussion with other students to promote collaborative learning. Lecturers will provide feedback at the end of each presentation and will assess it as pass or fail. ● If a group fails, they will be given the opportunity to re-sit by delivering another presentation within the same week, which will again be evaluated by the lecturers. If re-sit is also failed another 2000 word essay will be due in two weeks after the course is complete. ● Students have to clear both aspects, the presentation is pass/ fail and MCQ and both have assignment based examination have resits.
Content: Pre-Readings ● Good Clinical Research Practice guidelines ● Ethics in human health research ● Basics of Case Report Form (CRF) design ● Questionnaire construction and question writing ● Case studies on trial designs and best practices in questionnaires Clinical Study Designs and Statistics ● Research ethics ● Interventional vs. observational study designs ● Key concepts, levels of evidence, strengths and limitations ● Sampling, randomisation, and bias control ● Study objectives and endpoints ● Statistical principles, analysis approaches, and data safety monitoring ● Clinical trial phases, types, sample size, and power Clinical Study Protocols ● Study planning (sites, population, finances, research questions) ● Essential protocol components (background, objectives, endpoints, design, procedures, safety, reporting) ● Practical protocol and CRF development, including sample size calculation CRF Design and Data Collection ● CRF types, data flow, design standards, tools, and legal aspects ● Questionnaire and eCRF/EDC design ● Laboratory and data management considerations Study Management ● Regulatory and ethical framework ● Trial planning, conduct, monitoring, and safety reporting ● SOPs, project management, and trial close-out ● Reporting to funders and trial registry entry Study Outcomes and Impact ● Strategies of data dissemination ● Implementation research ● Influence of clinical research on policy/guideline development
Methods: Pre-Course Reading (30 hours) ● Participants receive pre-course readings for self-study (Guidelines etc. in PDF format) and complete the TRREE (Training and Resources in Research Ethics Evaluation) Online Module “Introduction to Research Ethics” ● Pre-readings will be essential for students to follow the face-to-face course Lectures and group work (45 hours) Lectures on the above topics are followed by student-centered approaches, such as discussions and interactions to consolidate course contents. Although concrete learning methods and activities may vary, the interactive part will be in form of the following: Group work, discussions, exercises and activities around reading materials, calculation exercises and data analysis tasks, case studies. Lecturer hours – 37 hours of lecturer led material and discussion. (31 hours lecture and student presentation – 6 hours ) 8 hours - Guided study & exam prep Good Clinical Practice certification (15 hours) Post course the material that was introduced during the course has to be completed and an online test is completed. Resit available online.
Prerequisites: Proof of English language proficiency: tropEd students from an accredited tropEd home institution who have passed a core course in English will be considered sufficiently fluent in the English language. Also, students who can provide proof of academic education at Bachelor’s level passed in English will be considered sufficiently fluent. Applicants not being able to fulfil either of these criteria will be asked to prove fluency by a TOEFL (iBT score >= 79) or IELTS (score >=6.0).
Attendance: Max. number of participants: 20; within this group size up to 10 tropEd Master’s students are admitted. Minimum students would be 5.
Selection: Students are selected on a first-come, first-serve basis
Fees: EUR 600,- Cancellation policy: For cancellations made before the registration deadline, a non-refundable fee of 100 EUR will be charged. For cancellations made after the registration deadline until the course start, a non-refundable fee of 300 EUR will be charged. In case of no-shows or cancellations from the start of the course, the full course fee will be charged.
Scholarships: none
Major changes since initial accreditation: 1 ECTS = 30 SIT added Initially accredited with 2 ECTS; submitted for re-accreditation during tropEd GA in Rabat (February 2020), reaccredited with 3ECTS.
Student evaluation: Students want more hours for the statistical work, like the group work, protocol development and GCP. ( March,2024).
Lessons learned: In order to keep sessions during the face-to-face module interactive, additional pre-readings with theoretical input on different clinical trial aspects will be given. Also, more time will be allocated for the development of the study protocol to allow for sufficient time for thorough completion of this task.
tropEd accreditation: Following GA in Basel in Sep 2015, Re-accreditation at Online GA 08.06.2020. Re-accreditation at Online GA Jan 2026. This accreditation is available until Jan. 2031.
Remarks: After attending this course, students will be able to understand the concept of clinical studies/trials, enabling them to act in a real-life clinical study situation, e.g. as a junior researcher under supervision of an experienced senior researcher.
Email Address:	ttu@lrz.uni-muenchen.de
Date Of Record Creation:	2016-09-18 16:46:05 (W3C-DTF)
Date Of Record Release:	2016-09-18 20:57:33 (W3C-DTF)
Date Record Checked:	2017-06-21 (W3C-DTF)
Date Last Modified:	2026-03-10 10:29:45 (W3C-DTF)