Biostatistics is a central element in clinical trials and consequently in audits. What are the duties and responsibilities of statisticians? Where does their work need to be visible and transparent? What do auditors look for?
This seminar provides you with the answers to these and other questions concerning statistics in clinical trials. Our experts will always provide practical information, due to their in-depth audit expertise. The course will be held in English, nevertheless both speakers are bilingual and it will also be possible to pose questions in German.
Subsequently, you will be more confident the next time you prepare for an audit, you will know what to look for and how to be GCP compliant.
Themen der Veranstaltung:
- GCP requirements and regulatory basics
- GCP audits in clinical trials: Essential workflow information
- Duties of the statistician during a clinical trial
- Audits to verify data integrity: What does the auditor look for?
- Biostatistics during a clinical trial: What is relevant in an audit?
Are you responsible for planning and conducting clinical trials and want to be well prepared for your next GCP audit?
Are you an auditor and want to know your responsibilities concerning the statistical aspects of clinical trials? Do you want to learn about the major issues and what to look out for?
Then this seminar is for you!
Autor: Dr. John Bührdel
Dauer der Veranstaltung: 22.06.2018
Quelle: FORUM Institut für Management GmbH
Pharma, GCP Audits, Biostatistics, Audit, clinical trial, statistician, statistics, Study statistician, statistical programmer, data integrity, sample size, Data monitoring, GCP, auditor, training, seminar, course
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