Issue Detection and Escalation in Clinical Trial Settings

Why Should You Attend:

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.

Areas Covered in the Seminar:

• Checking the investigators and IRB qualifications and training.
• Preventive risk mitigation methods including training and monitoring sites.
• Considerations for protocol violations.
• Issuing protocol deviations.
• Communication plans with issue escalations and contingency planning.
• Monitor report templates.
• Process maps for risk mitigations and action items including escalation.

Learning Objectives:

• Understanding of  responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance.
• Proactive monitoring to prevent issues.
• Project managing risk mitigation.
• Contingency planning.
• Issue escalation.

Who will Benefit:

This webinar will provide valuable assistance and procedures for sponsors, clinical site managers, CROs, and clinical trial vendors (central labs, drug supply imaging service companies). The following individuals would benefit from this webinar:

• Clinical operations
• Project managers
• Clinical Research Associates (CRA)
• Clinical Trial Associates (CTA)
• Medical monitors
• Pharmacovigilance specialists
• Site managers
• Principle Investigators

Instructor Profile:

John (Jack) McLane, Ph.D. COO and VP of Clinical and Regulatory Affairs at Clinquest, Inc. has over 25 years of experience in the pharmaceutical and medical device with both large and small pharmaceuticals and CRO. He has been directly involved in over 100 clinical studies, filed numerous INDs/ IDEs and three NDA/MAA submissions. As a leader in risk assessments and mitigations he understands and implements processes in complex teams to evaluate means to reduce risks from occurring and if they occur how they will be handled.

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