Sven Wassmann, MD, PhD, FESC
Gianluigi Savarese, MD, FESC
Post event resources
SESSION 1. HOW TO DESIGN AND RUN A CLINICAL TRIAL
SESSION 2. REGULATORY ASPECTS
SESSION 3. REGISTRIES and registry-based trials
SESSION 4. ISSUEs IN CLINICAL TRIALS: devices I
WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS I
CLINICAL TRIAL PARADE: WHAT´S NEXT – UPCOMING AND ONGOING CLINICAL TRIALS
ISSUEs IN CLINICAL TRIALS: devices II
WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS II
- Randomised controlled trials and subgroup analyses: A. Niessner
WORKSHOP: HOW TO INTERPRET CLINICAL TRIAL DATA
WORKSHOP: THINGS TO KNOW FOR JUNIOR INVESTIGATORS
This course is organised in collaboration with the Karolinska Institutet of Stockholm, AIDFM-CETERA Portuguese Academic CRO and the Swedish Cardiac Society.
Certification in Good Clinical Practice
Each workshop participant is certified in Good Clinical Practice (GCP) after the course.
GCP is an international ethical and scientific quality standard for the design, conduct, and recording and reporting of clinical trials that involve the participation of human subjects. Anyone managing or conducting research in the National Health Service should be aware of Good Clinical Practice and evidence of GCP training is mandatory for gaining Host Site Approval for a Clinical Trial of an Investigational Medicinal Product (CTIMP).
The course provides a review of the fundamentals of Good Clinical Practice. The training is based on the International Conference on Harmonisation GCP guidelines but also introduces The Medicines for Human Use (Clinical Trials) Regulations and Amendment Regulations 2006, which have transposed the EU Clinical Trials Directive. All latest additions are included. The course gives an overview of aspects applicable to all research.
100% of participants would recommend the course to their peers!
“The course allowed me not only to gain a deeper insight into the complex process of organising clinical trials, but it also offered an opportunity to discuss specific methodological pitfalls and interpret the results in cooperation with professionals who represent the highest level of expertise in the field. I highly recommend the course both to experienced investigators and to young researchers, since apart from the conventional aspects of clinical trials methodology; it also presented a novel approach to run the research efficiently and successfully.” Aleksandra Gąsecka, Poland