Managing Data at Arms' Length: China

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 24, 11:00AM - 12:30PM

Session Number:
108

Room Number:
251

Level:
Intermediate

Type:
Forum

Title:
Managing Data at Arms' Length: China

Chair(s):
Ralph Douglas Harkins, PhD
Senior Statistical Consultant and Project Manager
RDH Statistical Consulting Service, United States

Description:
This forum will focus on CFDA-approved sites, data generation and reporting, electronic data capture, and the role of clinical research coordinators, clinical research associates, and other data management professionals in Chinese clinical trials.

Learning Objective(s):
Discuss the role of CRAs, CRCs, QA, CTAs, data audits, quality control and data managers in clinical trials conducted in China.

Presentation(s) & Speaker(s):
CFDA Regulatory Processes
Ivan Yu Zhai, MD,MBA
CEO
GCP CMIC ClinPlus CRO/SMO, Ltd., China

Data Monitoring at Arms' Length
Ethel Kagan, RN
President
Innovations Clinical Research, LLC, United States

Drug Safety Monitoring at Arms' Length
Barton L. Cobert, MD,FACP
President
BLCMD Associates, LLC, United States