Taking up the responsibility of a clinical trial is dealing with rules and regulations; during this course you get familiarized with ICH-GCP, the laws and the practicalities of leading a study in your site. You receive hand-on information on informed consent process, safety reporting and audit preparation.
Investigators are trained on their specific duties within Clinical Research. In 1 day, they get to understand the regulations, GCP guidelines and their responsibilities with regards to safety reporting and informed consent. Participants will receive a GCP certificate showing their capacity to work according to the current laws and regulations.
Course time9h00 - 17h00
Who should attend
Medical Doctors looking to participate in Clinical Trials. Investigators conducting Clinical Research.
- ICH-GCP and the responsibilities of the investigator
- The clinical trial as opposed to regular medical practice
- Informed consent and patient recruitment issues
- Safety reporting
- Efficient study management & data recording
- Audit findings and practical tips for study sites
- To know everything about current clinical practice
- To understand the responsabilities of a Medical Doctor within Clinical Trials
- To fully comprehend the safety reporting procedure
- To be able to get a voluntary and understandable informed consent
- To give hands-on tips on improving recruitment