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Sunday, June 18 • 8:30am - 12:00pm
#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm

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Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

Learn what regulators are looking for from sponsors and CROs as they initially assess their vendors and audit investigator sites for compliance and oversee them for compliance and quality throughout the clinical trial. As clinical trials become more complex involving additional data and vendors, why is it that companies keep using the traditional audit plan? As technology has provided the transparency and tools needed for trending, review and analytics, why is it that companies have yet to evolve to utilize them? Discuss various risk-based methodologies for audit programs and how logistical issues such as governmental travel advisories, environmental travel restrictions, resource issues (such as timing, budget) and availability of qualified individuals (auditors) may necessitate innovation to accomplish audit goals. Discuss case studies to assess risk in various remote auditing options which may provide a snapshot of compliance when travel may not be possible at that time and may assist in training auditors or providing subject matter expertise as needed from statisticians, IT professionals, etc. Learn methods for selecting what to audit and to what extent the auditing should be performed based on factors which may contribute to, or increase/decrease risk to subject safety and rights or data quality/integrity. Produce an audit plan that can be adapted for use to qualify (initial and re-qualification) and audit vendors (CROs, pharmacovigilance, eCOA vendors, etc.), study sites, and internal processes (when the department is off-site). Use the plan for auditing study site data, trial master files (TMF), databases, imaging data, etc.

Who should attend?

This short course is designed for:
  • Quality personnel from sponsor companies, CROs, and vendors
  • Data Managers, Clinical Operations, CRAs, Clinical Scientists, Medical Monitors and other project leaders with ideas on how and what critical to quality data should be presented to auditors
  • Representatives/ consultants of companies that provide auditing services

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Determine which data is critical to quality using risk-based methodologies
    • Explore novel methods to access documents and data.
    • Develop more comprehensive and cross functional audit plans for oversight activities of vendors and CROs
    • New methods to host/ conduct a qualification, vendor, study site, or other GCP audits

avatar for Joanne Malia

Joanne Malia

Associate Director, Clinical Documentation Management, Regeneron Pharmaceuticals
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner... Read More →
avatar for Sarah Ann Silvers

Sarah Ann Silvers

Director, GCP Process Control and Compliance, Ce3
As Director, GCP Process Control & Compliance, Sarah oversees Ce3’s Clinical Quality Program- leading and conducting domestic and international audits (internal, sponsor, investigator, CRO, vendor, and TMF audits), writing procedure, educating staff and implementing regulation and... Read More →

Sunday June 18, 2017 8:30am - 12:00pm CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  Short Course, Tutorial |   11: Quality, Tutorial |   01: Data-BigData-eHealth, Tutorial
  • format json
  • Credit Type CME, IACET, RN
  • Tags Tutorial