Presentation, Seminar/workshop • Brno
WP1 Clinical Trial Management On-line Training
WP1 workshop will take a total of 4,5 hours and will be divided into two parts (Educational part 2,5hours, skills part 2 hours). The unique package includes the GCP training, covering the main GCP principles for the investigators/coordinators and other staff involved in clinical trials at the hospital/site level. The scientific package includes processes and ways to write and create medical documents as Informed Consent Forms, Protocol, Investigator Brochure, Medical Reports, Case Report Forms, etc. Pharmacovigilance package covering the basic pharmacovigilance principles, rules, and reporting in clinical trials. According to the project/clinical study, the Regulatory package enables the students to implement the international and national regulatory rules for clinical trials (submission, follow-up, reporting to regulatory authorities, ethics committees, and other respective authorities). The execution package covers the practical performance of different phases of clinical trials in oncology within hospital settings. The workshop itself will be held online.
https://www.pharmaround.cz/visegrad-v4-project