Title: Applied Clinical Research
Keywords: Research (in general)
Planning and programming (incl.. budgeting and evaluation)
Organisation
Management/leadership
Drugs and vaccines
Country: Germany
Institution: Germany - Center for International Health at the Ludwig-Maximilian-Universität München
Course coordinator: Arlett Heiber
Lisa Hoffaeller
Date start: 2021-01-25
Date end: 2021-02-19
About duration and dates: 1 preparatory week for pre-reading 1 week face-to-face course (from 2021 02 01 to 2021 02 05) and Post-course assignment (graded homework): submission 2 weeks after the course (2021 02 19)
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
ECTS credit points: 3 ECTS credits
SIT: Contact Self-Study
Pre-Reading 0 33
Lectures 19 0
Group Work
and Discussions 16 0
Start of graded
Homework during
course week 0 9
Exam 1 0
Finalisation
of graded Homework
after course week 0 12
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

• to 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)

• infer ways to utilize clinical trial findings (e.g. for policy development)
Assessment Procedures:
• 1 hour Multiple choice test on the last day of the face-to-face course (Grading A – E, F)
• Graded Homework:
• During course week, students will individually start designing a study protocol
• after course week: students will complete their study protocol and design a Case Report Form
• Submission of homework 2 weeks after the face-to-face course and rating by the facilitator (Grading A - E, F)

The final grade will be calculated as an equally weighted arithmetic mean of the 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. The maximum grade that can be awarded for a resubmitted assignment can be the pass mark Grade D.
Content:
Pre-readings cover
• Guidelines for good clinical research practice
• Capacity building on ethics in health-research involving humans
• Basics of case report form designing
• Guidelines on questionnaire construction and question writing
• Case studies: selected trial designs, best practice review regarding questionnaires

Introduction to Clinical Study Designs and Statistical Aspects in Clinical Trials
• Introduction to Research Ethics
• Interventional studies (e.g. trial) vs. observational studies (e.g. descriptive, cross-sectional, case-control, cohort, ecological)
• Terms, concepts and ideas of each study design; level of evidence
• Advantages and limitations of each study design
• Participant Sampling
• Examples: Which study design for which research question?
• Define study objectives and endpoints
• Randomisation
• Methods for avoiding bias
• General analysis principles
• Approaches to statistical analysis
• Data and safety monitoring
• Phases and types of clinical trials
• Sample size and power


Essentials of Clinical Study Protocols and Protocol Development
• Basic Study Considerations: incl. site assessment, population, financial constraints, research question and objectives etc.
• Introduction to essential parts and aspects of a clinical protocol (e.g. Title Page (General Information); Background Information; Rationale; Objectives; Study endpoints; Trial Design, Assessment and Treatments; Patient Enrolment; Trial Procedures; Reporting Adverse Events; Trial Surveillance etc.)
• Practical Protocol Development including the development of one’ s own protocol template for one’ s chosen research question, including sample size calculation. Case Report Form (CRF) Development

CRF Design and Data Collection (incl. CRF Types, Data Flow, CRF Design Process, Design Tools, Standards, Legal Aspects etc.)
• Practical CRF Development (incl. Question Answering Techniques, Wording; Questionnaire Specifics; ECRF/EDC Specifics etc.)
• CRF Design and Laboratory Considerations

Study Management
• Introduction to clinical trials
• Regulatory and ethical framework
• Trial planning and set-up
• Trial execution
• Project management plan
• Tracking and controlling
• SOPs and monitoring
• Safety reporting
• Trial completion

Study Outcomes and Impact
• Strategies of Data Dissemination
• Phase 4 studies and implementation research
• Influence of Clinical Research on policy/guideline development
Methods:
Self-Study: Pre-Course Reading (33 hours)
• Participants receive pre-course readings for self-study (Guidelines etc. in PDF format) and complete the TRREE Online Module “Introduction to Research Ethics”
• Pre-readings will be essential for students to follow the face-to-face course

Lectures (19 hours)
Teaching input by the lecturers to provide an introduction to and overview of the topics:
• Clinical Study Design
• Statistical Aspects in Clinical Trials
• Essentials of Clinical Study Protocols and Protocol Development
• Case Report Form (CRF) Development
• Study Management
• Study Outcomes and Impact

Group work and Discussions (16 hours)
Lectures on the above topics are followed by student-centred 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

Assessment for Learning: Exam and Graded Homework (22 hours)
Graded Homework during the face-to-face course: preparation of study protocol (9 hours)
Exam: Multiple choice test (1 hour)
Graded Homework after face-to-face course: completion of study protocol and CRF design (12 hours)
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: 15; within this group size up to 10 tropEd Master’s students are admitted
Selection:
Students are selected on a first-come, first-serve basis
Fees: EUR 600,-
Scholarships: none
Major changes since initial accreditation: 1 ECTS = 30 SIT added
Currently accredited with 2 ECTS; submitted for re-accreditation during tropEd GA in Rabat (February 2020)
Student evaluation: Students agree that this module covers all important aspects of conducting a clinical trial and found the sessions on protocol development particularly useful. While they liked the opportunity for discussions and tutored group work during the module, they would have appreciated additional, practical sessions on data analysis.
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 (graded homework) 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
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: 2020-12-03 12:28:06 (W3C-DTF)

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