69.00€
Clinical trials are very highly regulated sector requiring proper documentation, therefore there is a rule saying that “what is not documented, does not exist”. Course on clinical trial documentation provides key definitions and understanding of essential documents generated before the clinical phase of the trial, during the clinical conduct of the trial and after completion or termination of the trial as defined by the ICH GCP. Course is focused on the clinical study protocol, Investigator’s Brochure, subjects’ documents such as inform consent form and sites’ documents for instance electronic case report form, subject identification log and other documents generated by the clinical sites. After completion of each section, participants will be able to explain the role of each essential document, structure of those documents and the way those documents are linked together. Participants will get familiar with definition and examples of source documents and ALCOA principles. The course clarifies as well which documents are filed in the investigator/institution file, sponsor file or both files. This is essential knowledge needed for all clinical research professionals which is used in the everyday work. During the course participants will be provided with true examples of use of essential documents and issues which may occur during the clinical trial. Course is followed by several exercises: knowledge check, case study or work with essential documents. This is the perfect way to practice and self-check the newly gained knowledge.
Excellent communicator with can-do attitude and strong desire to learn. Project Manager with line management responsibilities focused on quality. Currently fulfilling the role of an Oversight Portfolio Manager working on a governance level, responsible for several studies of one client and oversight and support a group of CTMs allocated for those projects. Client oriented and dedicated team player. Long-term goal is to have an independent and responsible position as a global project director. Experience in pharmaceutical marketing, medical affairs and clinical trials gained in pharma companies and CROs.Founder and member of Polish Pharmaceutical Students’ Association. Member and head of the training group at Polish Association for Good Clinical Practice (GCPpl). Pharmacist with strong interest in clinical pharmacy. Academic teacher delivering lectures related with clinical trials.
Certificates: Soft Skills Trainer Certificate, Prince2 Foundation Training Certificate, Barnett GCP Certificate. Laureate and winner of a 3rd place of the national competition “Leaders of Clinical Trials (2021)” in the category Project Manager. Scholar of Leslaw A. Paga Foundation in the program “Healthcare Leaders”.
Privately foodie and enthusiast of cooking, travelling and fantasy books.
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