The well-known intensive course for clinical monitors, conducted by DDr. Hönel and Mag. Raffeiner for more than 20 years, in a new, interactive format now at GxP konkret!
Monitor Training Course – Training Course for CRA & CTA with Certificate of Competence
Blocked, intensive and updated with the latest information, you will be prepared for the job profile as a clinical monitor: All relevant legal matters are addressed, the new EU clinical trial regulations on medicinal products and medical devices, data protection, hospital legislations and, of course, ICH-GCP.
The speakers guarantee up-to-date information.
DDr. Hönel is known as an international auditor. He has a broad knowledge and experience, based on his former professional activities as head of the Austrian Inspectorate and former chairman of the Salzburg Ethics Committee. He is aware of the current implementations and places them in the international context.
Mag. Raffeiner is head of a CRO with a focus on project management and monitoring. He is still operationally active himself and with 25 years of professional experience he is one of the most experienced and competent monitors in Austria. Participants benefit from his experience, extensive knowledge, relevance to practice, as well as many support materials that are provided.
The Monitor course lives from numerous case studies from the daily work within clinical trials, from audits and inspections, and from interactivity, and thus guarantees rapid applicability in the daily work routine. A practical day complements the theory – this is already included in the course fee and distinguishes it from comparable offers by different course providers.
Module 1 of the Monitor course first introduces the basics of clinical trials. The legal basis – up-to-date, including the new EU-CTR Regulation 536/2014 and its implementation in Austria, as well as optional side glances on medical device studies – is highlighted. The speaker then moves into the field of clinical research and shows numerous practical examples from audits and inspections. This concept has proven itself over 20 years and guarantees high practical relevance.
Module 2 translates the knowledge into the daily work routine and will work out „hands on“ the activity of the clinical monitor on case examples. Tools are included as well as workshops to prepare for the different types of monitoring visits.
The concluding module (Module 3) will be a newly designed day with setting up a clinical study at centres as well as many implementation examples with both lecturers together.
MODULE 1 Webinar 2 days | Legal basis for clinical trials and NIS in Austria
Speaker: DDr. Alexander Hönel
- Definitions: Clinical Trial, Multicenter Clinical Trial, Non-Interventional Study (NIS), Compassionate Use
- Austrian Medicines Act (AMG) – Relevant aspects
- EU Clinical Trials Directive + EU Regulation 536/2014
- International guidelines for clinical trials (ICH, Good Clinical Practice (GCP))
- Labelling regulation
- Requirements for the conduct of a clinical trial
- Phases of clinical trials
- Competent-Authority procedures, notifications
- Ethics committee (procedures, tasks, approval)
- Inspections (definitions, goals, types)
- Registration deadlines
MODULE 2 Webinar 2 days | The Clinical Monitor / CRA – tasks, responsibilities, planning, work organization
Speaker: Mag. Andreas Raffeiner
- Definition, tasks and responsibilities
- Practical monitoring
- Center selection and study site preparation
- Study protocol
- Source data recording, CRF
- Electronic data capture and eCRF
- Monitor visit (preparation, conduct, follow-up)
- Routine on-site monitoring visit
- SAE Procedure
- Investigator folder
- Dealing with investigator/study team conflict situations
- Study registration / deregistration
- Common documentation gaps
- Study medication and drug accountability
- AE and SAE reporting
- Laboartory Documentation
- Source Data Verification (SDV)
- Archiving (according to GCP and SOPs)
MODULE 3 Presence 1 day | Implementation with practical examples, sample study and conclusion with certificate of competence
Speakers: Mag. Andreas Raffeiner & DDr. Alexander Hönel
If you are interested, please contact us.
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