Basic Course

In the basic course, we train pediatricians and their employees as investigators and studynurses in clinical practice. For conducting clinical trials, good, experienced investigators with solid quality management skills are needed. With this training, we provide the conditions for good clinical studies. Pediatricians who want to participate in clinical trials have, with this course, the opportunity to become adequately qualified. Here we consider the special responsibilities of assistants / study nurses: they will receive information regarding their own options, rights and obligations. They learn how to handle good clinical trials within a practice.

The course is entirely practical and extremely relevant and effective. Past participants found no comparable benefit when reading alone. Due to ongoing "off-label" discussions and the ever-growing need for qualified clinical trials in pediatrics, this course ensures the practice-oriented planning of studies. There is a considerable need, particularly in Allergy and Pulmonology. As is generally known, pediatricians frequently take part in pharmaceutical industry-sponsored studies without an adequate kownledge of "Good Clinical Practice" (GCP).

We sincerely invite you and your staff for training as an investigator or studynurse!
The training will be certified by the respective State Chamber of Physicians.

 

What are the outcomes of the basic course for pediatricians?

  • They learn the principles of study design (medicinal products act - AMG).
  • They become familiar with the GCP guidelines, legal, ethical and scientific requirements, and international standards for quality assurance.
  • They will understand the methods of proper doctor-patient communication (eg rules of conversation with parents of subjects).
  • They will understand and implement a study protocol, in order to know how to deal with study tasks and optimize time involved.
  • They receive, with this qualification, the right to adequate compensation.
  • In order to receive the approval of the ethic commitee to participate in studies, they need this corresponding training. Due to new european regulations including that, in the future, new drugs will only be approved if they have been tested on children (and explicitly for each age group), a higher amount of

Topics addressed during the basic program:

  • What is a clinical trial?
  • Responsibility of the participant (investigator, monitor, sponsor)
  • Design of a clinical study
  • Legal basis
  • The time before the start of the study
  • "Pre-study" of the monitor visit
  • Screening
  • Commencement of studies and patient recruitment
  • How to run an effectively informed discussion?
  • Patients and investigators
  • Investigational drugs
  • Documentation
  • Adverse events
  • special role of the monitor
  • The end of a study
  • Quality management (QM), Audits
  • Publication of results

Speakers

  • Prof. Dr. Albrecht Bufe (M.D.)
    Kinder-/Jugendarzt
    Ruhr-Uni Bochum
  • Dr. Tim Holland-Letz
    Abteilung Biostatistik
    DKFZ, Heidelberg
  • Dr. Roland Knecht(M.D)
    Kinder-/Jugendarzt
    Bretten
  • Ralph Köllges
    Kinder-/Jugendarzt, Kommuniktionstrainer
    Mönchengladbach
  • Eike Stöckmann
    Geschäftsführerin NETSTAP e.V.
    Borstel