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Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance August 2010

Course Description

Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

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Learning Objectives

  • Discuss how QA differs from QC and who is responsible for each
  • Determine who gets audited and factors and metrics for assessing when or why to audit
  • Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs)
  • Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs

Who Should Attend

  • Clinical Quality Assurance Auditors
  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates (CRAs)
  • Project Managers
  • Medical Monitors
  • Regulatory Affairs Professionals
  • Clinical Research Coordinators (CRCs)
  • Clinical Investigators (PIs)
  • IRB Administrators and Members

Instructor 

Elizabeth Ronk Nelson, MPH

Click here for complete trainer biographies

Course Length Time

2 hours; 1:00 - 3:00 p.m. Eastern

Course Dates 

August 26, 2010                                       

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)