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ACRP 2019 OnDemand

237 - Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective


Apr 14, 2019 3:15pm ‐ Apr 14, 2019 4:15pm



Credits: None available.

Non Member: $75.00
Members: $15.00

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 noncompliances 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.

Learning Objectives:

  • Identify appropriate Corrective and Preventative Action Plans (CAPAs) for common monitoring findings discuss ways to effectively implement CAPAs with sites.
  • Understand how to appropriately escalate issues to the Sponsor and the importance of properly documenting compliance issues in monitoring reports and follow-up letters.
  • Critically examine ways in which the Sponsor can attempt to secure compliance at a site where compliance issues have been identified.

Speaker(s):

  • Stephani Hulec, MS, CCRA, Associate Director of Clinical Monitoring Services, IMARC Research, Inc.
  • Meghan Kulaszewski, BS, CCRP, Lead Clinical Research Associate, IMARC Research, Inc.

Credits Available


Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective Exam

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