Tulsa Chapter: Webinar Replay: Identifying, Documenting, and Implementing Corrective Action Plans

• Stephani Hulec, MS, CCRA, Associate Director, Monitoring Services, IMARC Research, Inc.
• Megan Kulazewski, BS, CCRP, Lead Clinical Research Associate, IMARC Research, Inc.

• 11:30 am to 11:45 am - Chapter Update and News

• 11:45 am to 12:45 pm - Educational Presentation

Program Description:

This session will provide an overview on how to appropriately identify, document and address compliance issues noted at sites, from monitoring and Sponsor perspectives. There will be an overview of common monitor findings and a discussion about appropriate next steps for developing effective CAPAs. The escalation of issues to the Sponsor will be discussed along with how to adequately document compliance issues in monitoring reports and follow-up letters. Possible ways in which the Sponsor can handle non-compliances will be addressed, as well as the consequences and risks to the Sponsor and study if compliance issues are not addressed. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.

Upon completion of this Seminar, attendees should be able to:

1. Identify appropriate Corrective and Preventative Action Plans (CAPAs) for common monitoring findings and discussing ways to effectively implement CAPAs with sites.
2. Understand how to appropriately escalate issues to the Sponsor and the importance of properly documenting compliance issues in monitoring reports and follow-up letters.
3. Critically examine ways in which the Sponsor can attempt to secure compliance at a site where compliance issues have been identified.
4. Discuss risks when noncompliance issues are not addressed appropriately.

Target Audience: 

• CRCs
• CRAs
• Investigators
• Auditors
• Project Managers
• Regulatory Affairs/Compliance
• Data Managers (Site, Sponsor, CRO)
• Medical Monitor, Medical Officer, Project Physician
• Quality Assurance
• Clinical Research Administrators

Registration Cost: FREE to all Chapter, ACRP, and non-members

Contact hours: 1.0 ACRP contact hour is available for this program.

Membership is not required for online registration of contact hours.

To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program.
Log on to the ACRP website then “My Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:

• $15 Chapter Members
• $15 ACRP Members
• $30 Non-Members

Refund Policy: Not applicable

Level: Advanced