Issue Detection and Escalation in Clinical Trial Settings (Clinical Compliance)
Venue: Online Event
|Event Date/Time: Jun 19, 2012||End Date/Time: Jun 19, 2012|
In recent years the FDA has increased the number of clinical sites and trials that have been inspected and audited. The number of investigators under investigation or disqualified has increased. IRBs have been inspected and issued with 483 letters.
What would happen: If the site enrolls some subjects that don't meet all the entry criteria? Have unreported safety issues? Don't sign the CRF? Are not accurate in reporting the data? Don't follow their own SOP? Are these issues hidden in your monitoring reports or not there at all? The FDA does conduct audits of the sites and will issue 483 letters to either the sites or to sponsors. During a market review of data submitted for example an NDA they can disqualify the data if not consistent, they can disqualify a site if they have had protocol, GCP or SOP deviations. They can disqualify a whole study or application if the issues are systemic. Do you have the processes to assure compliance?
This webinar will help you understand the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.