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Site Inspections: Are You Ready?
Business Site Inspections: Are You Ready?

1. Site Inspections: Are You Ready? 2. Who performs site inspections? • Sponsor/CRO CRA or monitor, regulatory affairs, QA • Pre-Study visit • Site initiation visit…

Risk-based SDV Approaches-Pros & Cons, 2010
Documents Risk-based SDV Approaches-Pros & Cons, 2010

1. R E G U L A T O R Y A F F A I R S 745 Vadim Tantsyrra, MS, MA, DrPH (c) Director, Data Management, Infinity Pharmaceuticals Imogene Grimes, PhD Vice President. Statistics…

Regulations That Drive Monitoring Visits and FDA Audits: Preparing for a Clinical Research Monitoring Visit
Education Regulations That Drive Monitoring Visits and FDA Audits: Preparing for a Clinical Research...

1. Archer Eller, MS Clinical Trial Manager Pulmonology353-2060 [email protected] 2. }  1813 Massachusetts Vaccine Act}  1906 Theodore Roosevelt signed the PureFoods…

Planning and Surviving An Audit/Monitoring visit Carmen B. Jacobs, BS, RN,OCN, CCRP U.T. MD Anderson Cancer Center Houston, Texas U.S.A.
Documents Planning and Surviving An Audit/Monitoring visit Carmen B. Jacobs, BS, RN,OCN, CCRP U.T. MD Anderson...

PowerPoint Presentation Planning and Surviving An Audit/Monitoring visit Carmen B. Jacobs, BS, RN,OCN, CCRP U.T. MD Anderson Cancer Center Houston, Texas U.S.A Objectives…

MONITORING DIFFERENT TYPES OF TRIALS. BY OGUNDOKUN OLUSEGUN
Documents MONITORING DIFFERENT TYPES OF TRIALS. BY OGUNDOKUN OLUSEGUN

PowerPoint Presentation MONITORING DIFFERENT TYPES OF TRIALS. BY OGUNDOKUN OLUSEGUN BIOMEDICAL SCIENTIST / CLINICAL RESEARCH PROFESSIONAL BMLS (LAUTECH), PGD (Clin. Research.…

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