Module GW5100-KP05

Duration

1 Semester

Turnus of offer

each summer semester

Credit points

5

Course of studies, specific fields and terms:

• Master in Health and Healthcare Science 2019, compulsory, Research in the health and care sciences
• Master in Health and Healthcare Science 2025, compulsory, Research in the health and care sciences

Classes and lectures:

• Developing Study Protocols (seminar, 2 SWS)

Workload:

• 120 hours private studies and exercises
• 30 hours in-classroom work

Contents of teaching:

• Aims of study protocols
• Requirements for the content and structure of study protocols in health and health care sciences
• Study register and publication of study protocols
• Requirements for the reporting of study protocols (Reporting Guidelines)
• Ethical requirements for research in health and health care sciences/criteria for ethical review
• Strategies and methods for early and consistent involvement of stakeholders in study protocol development
• Develop, present, discuss, and revise study protocols related to own research questions
• Peer Review Methods
• Principles of good scientific practice
• Principles and procedures of scientific publishing and the application for third-party funding

Qualification-goals/Competencies:

• Knowledge and Understanding: Students will be able to name and justify the core content of a study protocol.
• Knowledge and Understanding: Students will be able to differentiate the content requirements of a study protocol depending on the type of study being pursued and other study characteristics.
• Knowledge and Understanding: Students will be able to critically evaluate the quality of a study protocol as well as the quality of a planned study using established criteria.
• Knowledge and Understanding: Students will be able to explain ethical requirements of research and relate them to the different steps of the research process.
• Knowledge and Understanding: Students will be able to describe and explain strategies for early involvement of stakeholders in study planning and implementation.
• Use, application, and generation of knowledge: Students will be able to formulate problem-driven answerable research questions and design appropriate study designs with all components (study type, setting, population, data collection instruments and methods, ethical considerations, involvement of stakeholders, etc.) to answer this research question. They can justify and critically reflect on their methodological decisions in the process.
• Use, application, and generation of knowledge: Students will be able to structure and describe their own study protocol according to available reporting criteria (Reporting Guidelines).
• Communication and cooperation: Students can appropriately appreciate critical comments on their own study protocol and weigh and classify them with regard to their relevance.
• Communication and Cooperation: Students will be able to present their own study protocol coherently and cohesively orally in a reasonable amount of time and defend it factually/technically.
• Communication and cooperation: Students can formulate and explain their own critical comments on the study protocols of others in a respectful and factually justified manner.
• Scholarly self-concept/professionalism: students will be able to explain the need for pre-publication of study protocols and will feel self-committed to appropriate publication practices.
• Scientific self-conception/professionalism: The students realistically assess their own research competencies and independently expand and deepen their basic methodological knowledge. In doing so, they recognize methodological scope for design and decision-making and, under guidance, independently decide on the implementation of decision-making/action alternatives after critically weighing up the advantages and disadvantages.

Grading through:

• Oral presentation and written report

Requires:

• Research Methods in Health Sciences (GW4100-KP08)

Responsible for this module:

• Prof. Dr. Katrin Balzer

Teacher:

• Department of Neurology
• Institute for Social Medicine and Epidemiology
• Prof. Dr. Katrin Balzer
• Prof. Annette Baumgärtner, PhD
• Prof. Dr. Kerstin Lüdtke

Literature:

• :

Language:

• German and English skills required

Notes:

Last Updated:

16.09.2025