Title: Applied Clinical Research
Keywords: Research (in general)
Planning and programming (incl.. budgeting and evaluation)
Organisation
Management/leadership
Drugs
Country: Germany
Institution: Germany - Center for International Health at the Ludwig-Maximilian-Universität München
Course coordinator: Karsten Schacht
Andrea Kinigadner
Date start: 2018-02-19
Date end: 2018-02-23
About duration and dates: One week (34 contact hours); Pre-reading (10 hours); Homework during course week (6 hours); Homework after course week (10 hours)
Classification: advanced optional
Mode of delivery: Face to face
Course location: CIHLMU Center for International Health, LMU Munich
Address: CIHLMU Center for International Health, Leopoldstr. 7, 80802 Munich, Germany
ECTS credit points: 2 ECTS credits
SIT: 60 SIT
Contact hours: 34
Self-Study: 26
Language: English
Description:
At the end of the module the student should be able to …

• formulate the research question, primary objectives and essential milestones of the study

• identify a suitable study design for different research questions

• compose operational study documents to plan and organize project execution

• prepare a protocol and design a Case Report Form (CRF).

• apply a range of tools to manage and monitor a clinical study (trial).

• use and interpret applicable regulatory and ethical guidelines relevant for clinical research

• suggest the pathway to translate study results to policy making.
Assessment Procedures:
• Performance during group work: students will be assessed by the facilitators for their active participation on a pass/fail basis
• Homework during course week: students will individually design a study protocol sketch which will be rated by the facilitator; time to prepare the study protocoal will be given (Grading A-D, F)
• Homework after course week: students will design a Case Report Form which will be rated by the facilitator (Grading A-D, F)
• Multiple choice test (Grading A-D, F)

The final grade will be calculated as an equally weighted arithmetic mean of the three graded assessment parts.

In case of failure of the MC test, students will be assigned a 2000-word essay on a topic as defined by the facilitators.
In case of failure of the homework assignments, these can be resubmitted within a time frame defined by the facilitator.
Content:
Clinical Study Designs and Fundamentals of Data Analysis
• Introduction to Clinical Study Designs
• Ethical considerations
• Statistical Implications
• Essentials of Clinical Study Protocols

Protocol Development
• Basic Study Considerations of a study example
• Practical Protocol Development

Case Report Form (CRF) Development
• CRF Design and Data Collection
• Practical CRF Development
• CRF Design and Laboratory Considerations

Study Management
• Practical Study Management
• Introduction to Managerial Essentials

Study Outcomes and Impact
• From Evidence to Policy
• Strategies of Data Dissemination
Methods:
Pre-course Reading Assignments
• Participants receive pre-course reading assignments
• Readings will be essential for students to follow the face-to-face course (10 hours)

Clinical Study Designs and Fundamentals of Data Analysis
• Lectures (8 hours)

Protocol Development
• Lectures (2 hours)
• Tutored Group Work (6 hours)
• Homework during course week: individual protocol development (6 hours)

Case Report Form (CRF) Development
• Lectures (5 hours)
• Tutored Group Work (7 hours)
• Homework after course week: individual CRF development (10 hours)

Study Management
• Lectures (3 hours)

Study Outcomes and Impact
• Lectures (2 hours)
Prerequisites:
Proof of English fluency: tropEd students from an accredited tropEd home institution who have passed a core course in English language will be considered sufficiently fluent in English language. Also students who can provide proof of academic education passed entirely in English language will be considered sufficiently fluent. Applicants not being able to provide either of these criteria will be asked to proof fluency by a TOEFL (iBT score >= 79) or IELTS (score >=6.0).
Attendance:
Max. number of participants: 15; Up to 10 tropEd Master’s students are admitted
Selection:
Students are selected on a first-come, first-serve basis
Fees: 1000.-Euro; for tropEd students 800.-Euro
Scholarships: none
tropEd accreditation:
Accredited in EC meeting in July 2016. This accreditation is valid until July 2021.
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: Kinigadner@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: 2017-10-10 04:43:57 (W3C-DTF)

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