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Thursday, June 22 • 10:45am - 12:00pm
#410: Of Course My Data Has Integrity … And I Can Prove It

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Presenters will share 1) an overview of the data integrity expectations for good clinical practice (GCP) (using MHRA draft guidance as foundation); 2) case studies (with different data sources and media) of how the described expectations have been executed in the GCP environment; and 3) differences between data quality and data integrity.

Learning Objectives

Distinguish between data quality and data integrity; Describe attributes and application of data integrity expectations in the GCP environment.

Chair

David William Fryrear, MSc

Speaker

Applying Data Integrity to Clinical Trials and Regulator Expectations: Comparing Standards from the FDA, EMA, and MHRA
Sherri A. Hubby

Data Integrity in FDA-Regulated Clinical Trials
Adam C. Donat, MS

Data Integrity: Not an Act But a Habit
Cinzia Piccini


Moderators
avatar for David Fryrear

David Fryrear

Senior Director, R&D Quality Assurance, AbbVie, Inc.
David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie.  In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management.  Prior to joining AbbVie in January... Read More →

Speakers
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Adam Donat

Branch Chief, CEB, OSI, Office of Compliance, CDER, FDA
Adam is the Branch Chief of the Compliance Enforcement Branch in FDA/CDER/Office of Compliance/Office of Scientific Investigations. He has been with FDA for 7 years, first within the Office of Compliance in CDRH, and now CDER. In his work, he is responsible for helping to ensure human... Read More →
avatar for Sherri Hubby

Sherri Hubby

Senior Director, Quality Assurance, Risk, and Compliance, Premier Research
Sherri Hubby's career in clinical research began in Dec 1998 as an FDA investigator responsible for conducting inspections of Clinical Investigators, IRBs, drugs,medical device. Sherri has directed QA operations for 2 CROs and an IRB. Sherri is currently the Senior Director of QA... Read More →
avatar for Cinzia Piccini

Cinzia Piccini

Medical Quality Organization, Biometrcis Consultant, Eli Lilly and Company
Mrs Piccini has extensive experience in clinical research activities, quality oversight, and interpretation and implementation of applicable regulations. In the last 14 years, she has been responsible for quality oversight to ensure the integrity of the clinical research data throughout... Read More →

Thursday June 22, 2017 10:45am - 12:00pm CDT
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session