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Good Clinical Practices Question and Answer Guide 2004

- $39.95

Developed with input from over 100 industry and government clinical trial and GCP experts, this new reference guide answers almost 400 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drug, biologics, and device trials. In one pocket handbook, you'll have the authoritative answers to hundreds of common and emerging questions, in 20 GCP-related areas, right at your fingertips:

  • FDA and ICH GCP Standards for Clinical Research
  • Form FDA 1572-Statement of Investigator
  • Informed Consent
  • Source Data/Documentation
  • Investigator/Site Requirements
  • Clinical Monitoring
  • Clinical Study Safety Reporting
  • HIPAA
  • Clinical Trial Protocols/Protocol Changes/Protocol Violations
  • Institutional Review Boards
  • Quality Assurance Activities/Study Auditing/FDA Inspections
  • Investigational Drug Accountability, Administration, and Labeling
  • Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
 

May 2004, 420 pp., 1-882615-70-0, $39.95




On-Demand GCP Refresher Training 

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Barnett 'Hands-On' In-Person and Web Seminar Workshop Series
Barnett "Hands-On" Workshops are designed to provide intensive, hands-on training in a highly targeted clinical research topic area in a very interactive and engaging learning environment. To view more details and available courses, click here.


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Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


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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)