DCR Bern, Education
Passer catégories de cours
Catégories de cours
Passer cours disponibles
Cours disponibles
How to use DCR Moodle Platform?
For teachers only
This section should help you to understand :
- What is DCR Moodle platform?
- How to create and manage a course space?
- How to add/manage resources?
- How to add/manage activities?
- How to enroll/unroll students?
- How to form student groups and group activities?
- How to create an exam?
- How to create an attendance list?
- How to provide a course certificate?
DCR Moodle Playground
For teachers only
This section is dedicated to exploration, experimentation, and creativity! 🎨
Add, delete, and change elements freely and let yourself be surprised by the possibilities (and limitations) of Moodle!
Just keep in mind that anyone can access and modify this section, so let's remain professional and respectful!
- Enseignant: Samantha Chan
- Enseignant: Anna Glenck
- Enseignant: Perrine Janiaud
- Enseignant: Rosamaria Lugarà
- Enseignant: Irene Marty
- Enseignant: Felix Rintelen
- Enseignant: Odile Stalder
- Enseignant: Kristina Stojkov
- Enseignant: Samantha Chan
- Enseignant: Perrine Janiaud
- Enseignant: Sylvain Losdat
- Enseignant: Sharon Mitchell
- Enseignant: Odile Stalder
Learning objectives
- Describe the various costs associated with all aspects of clinical trials for both the research and general community
- Analyze the factors that influence a study budget, including how different trial designs impact cost components.
- Evaluate the challenges involved in accurately estimating a study budget and identify strategies to address them
- Identify and differentiate the various types of costs encountered in clinical trial budget estimation
Module Summary
CONTENT
Learning outcomes
CONTENT
Learning objectives
At the end of the course, the participant can:
- Explain how to conduct a clinical trial
- Explain the roles and responsibilities of the investigator and site staff, the tools and documents needed and how to track and keep records during the course of the study
- Describe the informed consent process and the management of subjects’ safety and safety reporting
- Describe the process to handle, store and document the study medication and medical devices
- Enseignant: Samantha Chan
Module Summary
At the core of the clinical trials process lays the investigational medicinal product (IMP). Successful studies rely on the quality and efficient, timely delivery of their clinical trial supplies. The EU Directive on Clinical Trials (2001/20/EC) requires that all commercial clinical trials must be conducted using Good Manufacturing Practice (GMP) compliant supplies. IMP should be manufactured, handled and stored in accordance with applicable GMP. In practice, the IML lifecycle involves 7 sequential steps: study and packaging design, label design and randomization, packaging, distribution, study conduct, returns and drug accounting and destruction.
Clinical trials on medicinal products are regulated under the Human Research Act (HRA), especially via the Clinical Trials Ordinance (ClinO). Swissmedic is the competent authority for medicinal products; swissethics is the body for ethics committee oversight. From 15 August 2025, Switzerland apply ICH GCP E6(R3) Principles and Annex 1.
Learning outcomes
CONTENT
Learning objectives
- Apply core principles of investigational product management to ensure regulatory compliance and maintain clinical trial integrity.
Module Summary
The basic Statistics course prepares learners to apply core statistical concepts in the context of clinical research. Participants will learn to apply key statistical principles, distinguish between common study designs and justify their selection based on specific research objectives, and construct research questions that are aligned to statistical principles. They will develop the ability to outline and critically review the key components of the statistic aspects of a study protocol and a statistical analysis plan. In addition, learners will assess when advanced trial designs—such as adaptive trials—are warranted and appraise their implications for study implementation and interpretation.
Learning outcomes
At the end of this course participants will be able to apply core statistical concepts relevant to clinical research, including outcome types, effect measures and underlying estimands.
Learning objectives
- Classify statistical objectives in clinical research: description, modelling, or causal inference.
- Implement the key attributes of the estimand framework
- Discuss the role of intercurrent events in planning a study and during study conduct
- Apply different handling strategies for intercurrent events
- Classify different types of statistical variables used in clinical research
- Select appropriate statistical endpoints for clinical research questions.
- Interpret common summary effect measures.
- Interpret the concepts of hypothesis testing, p-values and confidence intervals
- Implement the core components for a sample size calculation
- Select and implement research questions and hypotheses which are aligned to core statistical principles.
Module Summary
CONTENT
Learning outcomes
CONTENT
Learning objectives
At the end of the course, the participant can:
- Explain how to conduct a clinical trial
- Explain the roles and responsibilities of the investigator and site staff, the tools and documents needed and how to track and keep records during the course of the study
- Describe the informed consent process and the management of subjects’ safety and safety reporting
- Describe the process to handle, store and document the study medication and medical devices
- Enseignant: Perrine Janiaud
- Enseignant: Sharon Mitchell
- Enseignant: Felix Rintelen
- Enseignant: Andrea Daniela Singer
Module Summary
Please find in this module all the documents and supporting materials required to successfully complete your immersion week at the Department of Clinical Research (DCR) Bern.
If you have any questions, please contact education.dcr@unibe.ch
Learning outcomes
At the end of this experience, participants will be able to:
- Analyze the roles and responsibilities of key stakeholders involved in clinical research, and differentiate how their contributions impact trial conduct and outcomes.
- Evaluate the functions of Departement of Clinical Research (DCR) within the Swiss clinical research landscape, and assess their contributions to study quality and efficiency.
- Critically assess current clinical research priorities in Switzerland, with a focus on professionalization, and interpret their implications for clinical trial practice.
- Apply principles of patient and public involvement (PPI) to design ethically and socially responsive clinical trial approaches.
- 5. Design and develop key elements of a clinical trial protocol (e.g., study design, endpoints, stakeholder integration) in collaboration with DCR support structures.
Learning objectives
- Analyze the roles and responsibilities of key stakeholders involved in clinical research, and differentiate how their contributions impact trial conduct and outcomes.
- Evaluate the functions of the Department of Clinical Research (DCR)) within the Swiss clinical research landscape, and assess their contributions to study quality and efficiency.
- Critically assess current clinical research priorities in Switzerland, with a focus on professionalization, and interpret their implications for clinical trial practice.
- Apply principles of patient and public involvement (PPI) to design ethically and socially responsive clinical trial approaches.
- 5. Design and develop key elements of a clinical trial protocol (e.g., study design, endpoints, stakeholder integration) in collaboration with DCR support structures.
All the information you need to prepare your DCR PPI consultation 1.
Key point summary of your first DCR PPI consultation.
An overview of the support the DCR PPI team can provide.
.text-white
SNSF IICT Call
Information and templates to help you prepare and submit the PPI sections of your Letter of Intent (LOI).
Lernergebnisse
Am Ende dieses Kurses sind die Teilnehmer in der Lage, klinische Forschung am Menschen, klinische Studien und Beobachtungsstudien zu definieren sowie die Elemente des klinischen Studienprozesses und die Phasen klinischer Studien zu beschreiben.
Verbindungen zum Engagement als PPI- Contributor
Dieser Kurs bietet:
- ein Verständnis für klinische Studien und Einblicke in deren Konzeption und Durchführung – Bereiche, in denen PPI-Contributors in der Regel ihre Ideen einbringen und Einfluss nehmen.
- Schlüssel Die Terminologie klinischer Studien – Behandlung und Kontrolle – bietet Möglichkeiten, die Funktionsweise klinischer Studien zu verstehen, was Ihnen hilft, nachzuvollziehen, wie die Teilnehmer die Studie erleben und warum die Forscher bestimmte Fragen stellen.
Lernergebnisse
Am Ende dieses Kurses werden die Teilnehmer in der Lage sein:
- den Zweck des Schweizer Gesetzes über die Forschung am Menschen, der Deklaration von Helsinki und der Grundsätze der guten klinischen Praxis definieren und erläutern
- den Prozess der Prüfung und Genehmigung klinischer Studien beschreiben
- die verschiedenen Rollen in klinischen Studien sowie die mit jeder Rolle verbundenen ethischen Verantwortlichkeiten, wissenschaftlichen Vorschriften und rechtlichen Anforderungen definieren
Verbindungen zum Engagement als PPI-Contributor
Dieser Kurs bietet:
- vermittelt Kenntnisse über Gesetze, Vorschriften und Regeln im Bereich der klinischen Forschung und vermittelt Einblicke in den rechtlichen und ethischen Kontext klinischer Studien. Dies bereitet die PPI-Contributors auf ihre Tätigkeit als PPI-Contributors vor
- Kenntnisse über den Prozess der Begutachtung und Genehmigung klinischer Studien sowie über die verschiedenen Rollen in der klinischen Forschung – Forscher, Zulassungsbehörde und Studienteilnehmer – vermitteln Einblicke in die Funktionsweise der klinischen Forschung, was den PPI-Mitwirkenden Möglichkeiten bietet, ihr Wissen über die klinische Forschung zu vertiefen
Lernergebnisse
Am Ende dieses Kurses werden die Teilnehmer in der Lage sein:
- Beschreiben Sie die vier Phasen klinischer Studien – einschließlich der Entwicklungs-, Planungs-, Durchführungs- und Abschlussphase – und was jede Phase beinhaltet
- die Abschnitte des Studienprotokolls und die Rolle der wesentlichen Dokumente in klinischen Studien erläutern
- beschreibt die Durchführungsphase, einschließlich der Anwendung von Ein- und Ausschlusskriterien bei der Vorauswahl und Rekrutierung potenzieller Teilnehmer sowie den Ablauf der Studienbesuche
- einen Überblick darüber zu geben, wie klinische Studien abgeschlossen werden und wie Informationen an die wissenschaftliche Gemeinschaft und die Öffentlichkeit weitergegeben werden
Verbindungen zum Engagement als PPI-Contributor
Dieser Kurs bietet:
- Wenn Sie die Phasen klinischer Studien und deren jeweilige Inhalte kennen, können Sie besser nachvollziehen, wie Teilnehmer rekrutiert und geschützt werden und warum die Forscher auf das Feedback der PPI-Contributor angewiesen sind
- Das Wissen über die Planung, Umsetzung und Durchführung klinischer Studien bietet die Möglichkeit, deren Funktionsweise besser zu verstehen. Dies hilft Ihnen dabei, nachzuvollziehen, wie die Teilnehmer die Studie erleben und warum die Forscher bestimmte Fragen stellen
Lernergebnisse
Am Ende dieses Kurses werden die Teilnehmer in der Lage sein:
- Definieren Sie den Begriff „Patient and Public Involvement“ (PPI) im Zusammenhang mit der klinischen Forschung
- beschreiben, welche Rolle PPI-Contributor in der klinischen Forschung spielen, welche Rechte und Pflichten sie haben und wie sie sich auf ihre Arbeit vorbereiten können
Verbindungen zum Engagement als PPI contributor
Dieser Kurs bietet:
- Ein Verständnis der Rollen, Rechte und Pflichten von PPI-Contributor hilft ihnen, sich auf ihre Arbeit in PPI-Gremien vorzubereiten, was wiederum dazu beiträgt, die Erwartungen und Erfahrungen der PPI-Contributor zu prägen
- Kenntnisse über die Rollen, Rechte und Pflichten von PPI-Contributors sowie über die Art der Aufgaben, die auf PPI-BContributors zukommen, sind eine wesentliche Voraussetzung für den Aufbau wertvoller Beziehungen zu Forschern, Forschungsteams und anderen PPI-Contributors
Learning outcomes
At the end of this course participants will be able to define clinical research with humans, clinical trials, and observational studies and to describes elements of the clinical trial process and clinical trial phases.
Connections to being a PPI contributor
This course provides:
- an understanding of clinical trials and insight about how clinical trials are designed and conducted, which are areas PPI contributors typically share their ideas and influence.
- key clinical trial terminology—treatment and control—presents opportunities for understanding how clinical trials function, which helps you consider how participants experience the trial and why investigators ask specific questions.
Learning outcomes
At the end of this course participants will be able to:
- defines and explains the purpose of the Swiss Human Research Act, the Declaration of Helsinki, and the Rules of Good Clinical Practice
- describes the process of reviewing and approving clinical trials
- defines the various roles in clinical studies and the ethical responsibilities, scientific regulations, and legal requirements associated with each role
Connections to being a PPI contributor
This course provides:
- an understanding laws, regulations, and rules pertaining to clinical research and provides insight into the legal and ethical context surrounding clinical trials. This prepares PPI contributors for their work as PPI contributors
- knowledge of the process of reviewing and approving clinical studies and the various roles in clinical research—researcher, regulatory authority, and research participant—provides insight into how clinical research functions, which presents PPI contributors with opportunities for furthering their knowledge about clinical research
Learning outcomes
At the end of this course participants will be able to:
- describes the four stages of clinical trials—including the development, planning, implementation, and concluding stages—and what each stage entails
- explains the study protocol sections and the role of essential documents in clinical trials
- details the implementation stage, including applying inclusion and exclusion criteria when screening and recruiting potential participants, and what happens during study visits
- overviews how clinical trials are concluded and how information is shared with the scientific community and the public
Connections to being a PPI contributor
This course provides:
- an understanding the stages of clinical trials and what each stage entails, helps you better understand how participants are recruited and protected and why investigators need PPI contributor feedback
- knowledge on additional information about how clinical trials are planned, implemented, and conducted presents opportunities for understanding how clinical trials function, which helps you consider how participants experience the trial and why investigators ask specific questions
Learning outcomes
By the end of this course, participants will be able to:
- Define the term “Patient and Public Involvement” (PPI) in the context of clinical research
- Describe the role of PPI contributors in clinical research, their rights and responsibilities, and how they can prepare for their work
Connections to being a PPI contributor
This course provides:
- An understanding of the roles, rights, and responsibilities of PPI contributors helps them prepare for their work on PPI panels, which in turn helps shape the expectations and experiences of PPI contributors
- Knowledge of the roles, rights, and responsibilities of PPI contributors, as well as the types of tasks they will encounter, is essential for building valuable relationships with researchers, research teams, and other PPI contributors
Acquis d'apprentissage
A la fin de ce cours, les participants seront capables de définir la recherche clinique chez l'humain, les essais cliniques, et les études observationnelles, de décrire les processus et les phases des essais cliniques.
Connexions avec le rôle de PPI contributor
Ce cours fournit:
- une compréhension des essais cliniques et un aperçu de la manière dont les essais cliniques sont conçus et menés, quelles sont les domaines dans lesquels les PPI contributors partagent généralement leurs idées et exercent leur influence.
- La terminologie clé des essais cliniques — « traitement » et « groupe témoin » — permet de mieux comprendre le fonctionnement des essais cliniques, ce qui vous aide à vous représenter comment les participants vivent l'essai et pourquoi les chercheurs posent des questions spécifiques.
Acquis d'apprentissage
A la fin de ce cours, les participants seront capables de:
- définir et expliquer l'objectif de la loi suisse relative à la recherche sur l'être humain, de la Déclaration d'Helsinki et des règles de bonnes pratiques cliniques
- décrire le processus d'examen et d'approbation des essais cliniques
- définir les différents rôles dans les essais cliniques, ainsi que les responsabilités éthiques, les réglementations scientifiques et les exigences légales associées à chacun de ces rôles
Connexions avec le rôle de PPI contributor
Ce cours fournit:
- une compréhension des lois, des réglementations et des règles relatives à la recherche clinique, et donne un aperçu du contexte juridique et éthique des essais cliniques. Cela permet aux PPI contributors de se préparer à leur rôle de PPI contributor
- une connaissance du processus d'examen et d'approbation des études cliniques, ainsi que des différents rôles impliqués dans la recherche clinique — chercheur, autorité réglementaire et participant à la recherche — permet de mieux comprendre le fonctionnement de la recherche clinique, ce qui offre aux PPI contributors l'occasion d'approfondir leurs connaissances en la matière
Acquis d'apprentissage
A la fin de ce cours, les participants seront capables de:
- décrire les quatre phases des essais cliniques — à savoir la conception, la planification, la mise en œuvre et la conclusion — ainsi que ce que chacune d'elles implique
- expliquer les différentes sections du protocole d'étude et le rôle des documents essentiels dans les essais cliniques
- décrire en détail la phase de mise en œuvre, notamment l'application des critères d'inclusion et d'exclusion lors de la sélection et du recrutement des participants potentiels, ainsi que le déroulement des visites de suivi
- avoir une vue d'ensemble de la manière dont les essais cliniques sont menés à bien et dont les informations sont communiquées à la communauté scientifique et au grand public
Connexions avec le rôle de PPI contributor
Ce cours fournit
- une compréhension des différentes phases des essais cliniques et ce que chacune d'entre elles implique vous aide à mieux saisir comment les participants sont recrutés et protégés, et pourquoi les chercheurs ont besoin des commentaires des PPI contributors.
- des informations supplémentaires sur la manière dont les essais cliniques sont planifiés, mis en œuvre et menés permet de mieux comprendre leur fonctionnement, ce qui aide à se représenter comment les participants vivent l'essai et pourquoi les chercheurs posent des questions spécifiques
Acquis d'apprentissage
A la fin de ce cours, les participants seront capable de:
- Définir la notion de « Patients and Public Involvement » (PPI) dans le contexte de la recherche clinique
- Décrire le rôle des contributeurs PPI dans la recherche clinique, leurs droits et leurs obligations, ainsi que la manière dont ils peuvent se préparer à leur travail
Connexions avec le rôle de PPI contributor
Ce cours fournit:
- Une compréhension des rôles, des droits et des obligations des PPI contributors les aide à se préparer à leur travail au sein des comités PPI, ce qui contribue à son tour à façonner les attentes et les expériences des PPI contributors
- La connaissance des rôles, des droits et des obligations des PPI contributors, ainsi que de la nature des tâches qui leur incombent, est une condition essentielle pour établir des relations fructueuses avec les chercheurs, les équipes de recherche et les autres PPI contributors
- Enseignant: Carla Flurina Jenal
- Enseignant: Ursula Thormann
Learning objectives
- Describe the various costs associated with all aspects of clinical trials for both the research and general community
- Analyze the factors that influence a study budget, including how different trial designs impact cost components.
- Evaluate the challenges involved in accurately estimating a study budget and identify strategies to address them
- Identify and differentiate the various types of costs encountered in clinical trial budget estimation
Module Summary
The basic Statistics course prepares learners to apply core statistical concepts in the context of clinical research. Participants will learn to apply key statistical principles, distinguish between common study designs and justify their selection based on specific research objectives, and construct research questions that are aligned to statistical principles. They will develop the ability to outline and critically review the key components of the statistic aspects of a study protocol and a statistical analysis plan. In addition, learners will assess when advanced trial designs—such as adaptive trials—are warranted and appraise their implications for study implementation and interpretation.
Learning outcomes
At the end of this course participants will be able to apply core statistical concepts relevant to clinical research, including outcome types, effect measures and underlying estimands.
Learning objectives
- Classify statistical objectives in clinical research: description, modelling, or causal inference.
- Implement the key attributes of the estimand framework
- Discuss the role of intercurrent events in planning a study and during study conduct
- Apply different handling strategies for intercurrent events
- Classify different types of statistical variables used in clinical research
- Select appropriate statistical endpoints for clinical research questions.
- Interpret common summary effect measures.
- Interpret the concepts of hypothesis testing, p-values and confidence intervals
- Implement the core components for a sample size calculation
- Select and implement research questions and hypotheses which are aligned to core statistical principles.