Common GCP Violations and Site Mistakes - How to Avoid them (Clinical Training)
Venue: Online Event
|Event Date/Time: Aug 31, 2011||End Date/Time: Aug 31, 2011|
GCP Investigator site audits are a routine and a necessary part of the clinical trial process. If you are participating in a clinical trial or multiple trials as a Principal Investigator, a study coordinator, a monitor, or even as the IRB chances are that you may be audited. This Webinar will cover the most frequently found GCP violations / mistakes that are often found during the audit process.
Areas Covered in the Seminar:
- The historical background of why studies are audited and the purpose of audits.
- The regulatory requirements for the BIMO program.
- Studies targeted for auditing?
- How following GCP will end up making you look good to inspectors?
- How do you prepare for an audit?
- What Does the Inspector/Auditor look for?
- What are the common GCP mistakes sites make?
- How to prevent and detect misconduct and fraud?