Medical Faculty

"Clinical Research"

Continuing medical education in oncology (Certificate of Advanced Studies)

Continuing medical education "Clinical Research"
Medical Director: Prof. Dr. Dietrich Rothenbacher

The 4-month certificate continuing medical education course “Clinical Research” (Certificate of Advanced Studies, CAS) provides you everything you need for the proper conduct of a clinical trial and its subsequent publication. In the first course, you recapitulate or learn "Biometry", i.e. biostatics and how to apply the different methods properly. The courses "Clinical Trials" and "Ethical Aspects" contain knowledge, guidelines, ethics in the adherence to guidelines, and training from the inception of a trial, throughout its proper conduct and conclusion to its publication. The online learning phase concludes with a very interactive course on project management and other aspects that play a role in drug approval and reimbursement.

During the final seminar you will sit your module examination after an intensive and very helpful biometry repetition, refresh your knowledge of biometrics and learn how to extract molecular diagnostics from databases independently.

In addition, you will be joining our Master's students and the participants of the “Management”-Course for the communication and presentation training and may explore personal coaching. After a visit to a local production plant of biosimilars, you will be able to join the elder class for their thesis presentations. You will furthermore receive scientific writing and literature management training.

Upon successful completion of this course you will recieve also the Certificate of Good Clinical Practice (GCP).

 

At a glance

  • Duration: 4 months flexible online learning
  • Continuing education in English
  • Small groups (max. 20 people)
  • Costs:
    5. 275,- € (in 2 instalments)
    4. 875,- € (for one-off payment)
  • International networking
  • Personal coaching
  • 82 CME points
  • Start: April (yearly)
    Deadline for applications: 15 March

Detailed information on continuing medical education "Clinical Research"

What am I going to learn?
How does the programme suit me?
How am I going to learn?

Agenda and curriculum

Blended Learning – a contemporary learning concept

The continuing medical education module “Clinical Researchy” follows the Advanced Oncology Blended Learning concept. This means that 90% of the lessons are available online as a video module. Our Advanced Oncology library with the relevant literature is available for download. You always have the opportunity to clarify your questions directly with us, be it content or organisation. Of course, your content-related questions will be clarified immediately with the respective lecturer.

Course 1: Biometry:

Biometry focuses on key aspects of biostatistics and their application to the field of oncology. The units comprise study types, statistical tests, survival analysis, and sample size estimation for clinical trials in oncology.

  • Introduction to Biometry and Study Types
  • Design of Experiments
  • Descriptive Statistics
  • Graphical Methods
  • Diagnostic Tests
  • Statistical Tests
  • Linear Regression
  • Dichotoumous Outcome
  • Survival Analysis
  • Sample Size Estimation
  • Steps in Analysing and Reporting
  • Designing Clinical Trials

Course 2: Clincal Trials

This course delivers the toolbox for setting up, running and publishing a clinical trial. Aspects like quality assurance and transfer of study results into clinical rpractice are being discussed by examples from the CCCU-based clinical trials center.

  • Evidence Based Medicine
  • Protocol Development - From Idea to Protocol
  • Trial Registration
  • Scientific Writing
  • Data Management
  • Trial Master File and Investigator Site File
  • Study Initiation and Activation
  • Investigational Medicinal Product Management
  • Biobanking - Sample Collection and Informed Consent
  • Quality Management in Clinical Trials
  • Safety Surveillance
  • End of Trial
  • Assessment of Study Results and Publication
  • Transfer of Stdy Results into Clincal Practice
  • Drug Development

Course 3: Ethical Aspects

This course deals with ethical principles for informed consent, biobanking, study participation, collaboration between stakeholders with a different background (academic/industry). Equally important is the unit on the prevention and the detection of scientific misconduct and fraud.

  • Application for Clinical Trials in Europe
  • The Application Process from the ERC's View
  • Informed Consent
  • Participants Insurance
  • Ethical Principles for Collaboration
  • Prevent and Detect Scientific Misconduct and Fraud

Course 4: Project Management

This course provides basics in project management with case scenarios and problem-solving strategies from the pharmaceutical industry.

  • Project Management
  • Case Studies
  • Planning and Manging a Registry
  • GMP during Pharmaceutical Development and Manufacturing
  • Post-Approval Safety Management
  • Systematic Reviews and Meta-Analysis

  • Introduction to Health Economics

     

Participants and goals

Precondition

The continuing medical education module “Clinical Research” is perfect for

  • Specialists (and specialists-to-be, i.e. fellows in clinical training) in oncology and haematology
  • Physicians from neighbouring disciplines
  • Scientists (natural and economic sciences) if you would like to deepen your knowledge of oncology

All content is based upon the ESMO/ASCO Recommendations for a Global Curriculum in Oncology.

Your previously acquired knowledge

You will need the following:

  • Physicians and Scientists: Professional experience of at least one year 

Your learning objective

  • You will update your knowledge of biometry to the latest standards.
  • You will learn everything you need to conduct clinical trials and publish their results.
  • You will be able to understand and apply all the requirements of Good Clinical Practice (GCP) and Good Scientific Practice (GWP) and act as a principal investigator.
  • You will have acquired key competencies for project management.

Your personal support

Throughout the entire period of your continuing medical education programme, you will have direct personal contact with Dr. Uta Schmidt-Strassburger, who is your contact person for all questions concerning your education.

Study smart: The “Study Advanced Oncology” platform

Advanced Oncology Blended-Learning: 90% Online learning, 10% Presence workshops

In the contining education “Clinical Research” you learn 90% online, self-determined and flexible in time. About 10% of the contining education time is covered by the workshop seminars.

Your seminar documents

You will receive all important information in digital form before starting your further education. Your seminar documents will be made available for download on the learning platform.

Digital learning platform

At the beginning of the contining education, you will receive access to our learning platform “Study Advanced Oncology”, which was redesigned in 2021. Here you will find all your teaching materials including learning videos and documentation. You use the platform as a browser application without additional installation. To participate successfully, all you need is a computer with internet connection, a microphone and a webcam (internal microphone and webcam are also possible).

The contining education itself contains many interactive elements that make the learning material very lively and varied. Up to the exam, you will learn flexibly and independently in terms of time and location. During this time, the scientific director, Dr. Schmidt-Strassburger, will be at your disposal to answer any questions regarding the content of the module.

Presence Seminars: Networking and Examinations

We organize our presence seminars in the creative and inspiring rooms of Villa Eberhard in Ulm, Baden-Württemberg. At the beginning of the classroom seminars, you will take your exam. The seminars last 3 or 4 days and offer a varied program with plenty of time for teamwork and creative discussions in workshops.

What am I going to learn?
How does the programme suit me?
How am I going to learn?

Dates and details

  • Deadline for registration: Annually 15 March

  • Virtual introduction to the learningplatform: end of March (online)

  • Online learning phase: April 2025 – July 2025

  • Seminar: 14.-17. July 2025. Exam: 14. July 2025

     

Everything else you need to know

Introduction to the learning platform “Study Advanced Oncology”

At the beginning of your advanced training, we invite you to a virtual introductory seminar, where we will introduce you to the learning platform “Study Advanced Oncology. ” Here you will find the learning content for the module you have booked in a well-structured form. In addition to the intuitive use of our Moodle-based learning management system, you will also get to know the communication functions of the system, through which you can exchange ideas with your lecturers and colleagues. The learning platform, updated in 2021, contains all didactically prepared instructional videos that you can view individually. For each learning unit you will find further literature and tasks for self-examination of your learning progress.

Quality management

During your continuing education and after the seminar days, we ask you to evaluate your learning units and seminars. This evaluation is an important tool of our quality management. We report your evaluations back to our instructors and thus guarantee the consistently high quality of our modules.

Attendance Seminar

The attendance seminar will be held in the exclusive conference rooms of the university's own Villa Eberhardt in Ulm, which is easily accessible by public transportation. Travel arrangements to and from the seminar will be made by the participants themselves. We will provide you with all the necessary information about the seminar in due time. We recommend arriving by train. We can assist you with the organization of your accommodation, but please note that the cost of accommodation is not included in the tuition fees and must be borne separately. Lunch is included in the seminar costs, while breakfast and dinner will be organized by the participants themselves.

Certificate

Upon successful completion of the “Clinical Research” module, you will receive the corresponding Certificate of Advanced Studies (CAS). This contining education is certified with 82 CME (further contining education points of the Baden-Württemberg Medical Association) or 10 ECTS points.

Notification "Clinical Research"

  • Please allow cookies in your browser
I apply for the "Management":

Here you will find information on admission regulation, fee regulations and data protection.

FAQ

Physicians (specialists or specialists-to-be) in oncology and haematology or from neighbouring disciplines with a professional experience of at least one year or

Scientists (natural, engineering and economic sciences) with a professional experience  of at least one year.

 

Please submit the notification (s. a.) by March 15 at the latest.

Thereafter you will receive a confirmation message with the list of the requested documents which you have to submit then via email.

  1. Original Bachelor degree certificate in medicine, natural sciences, engineering or economic courses or equivalent at the level of usually four years of studies or 240 ECTS credits.
  2. Original transcript of records (or equivalent) including the official grading scale (minimum grade for passing the Bachelor degree or equivalent, maximum grade)
  3. Certified translations in English or German of the documents if the originals are not in English or German.
  4. Employment verification of the professional experience by indicating the time periods 
    -->Note: This serves to ensure that the required professional experience has been earned. You do not need to document all employment of your professional life, just the year required for admission.
  5. Curriculum Vitae
     

The tuition fee is 4,875 € for single payment respectively 5,275 € (for payment in 2 instalments).
Travel, living expenses and accommodation costs during the attendance seminars is not included in the fee.
 

The course takes one semester.

The course starts every year in April.

The tuition language is English. There is no requirement to be proficient in German.

The introduction to the learning platform will be held as an online seminar (1 day, end of March).

There is one mandatory attendance seminar (4 days: Monday to Thursday in July) where the exam will be held as well.

The exam will be held at the end of the course during the mandatory attendance seminar. The exam is performed tablet- or paperbased and consists of a selection of single-choice-questions covering the subject of the course.

Upon successful completion of the “Clinical Research” module, you will receive the corresponding Certificate of Advanced Studies (CAS). Furthermore, you will receive the GCP-Certificate.

This continuing medical education is certified with 82 CME (further continuing medical education points of the Baden-Württemberg Medical Association) or 10 ECTS points.

Organisation