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UPCOMING LIVE SEMINARS
 






Writing Protocols for Diagnostic Studies

Upcoming Courses
Course #: BI11566
June 2, 2014
12:00 PM - 1:30 PM Eastern
$695.00
Course #: BI11664
July 17, 2014
2:30 PM - 4:00 PM Eastern
$695.00

Course Description

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate protocols for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these protocols, how they differ from the standard pharma protocols, the guidances to follow for reference, and the regulatory environment surrounding sample collection and informed consents for de-linked samples.

Learning Objectives

  • Describe the sample collection process, delinking, and sample handling
  • Differentiate between the requirements of a traditional pharma protocol and a diagnostics protocol
  • Identify the elements required for a sample collection protocol
  • Identify the elements required for an accuracy study protocol
  • Identify the elements required for a reproducibility study protocol
  • Describe the regulatory documents required, and when they are required, including informed consent

Who Should Attend

  • Medical Directors
  • Medical Writers
  • Clinical Research Associates
  • Clinical Scientists
  • Regulatory Affairs Professionals
  • Research and Development Personnel
  • CRO Personnel
  • Personnel planning a change from the pharma sector to the diagnostic sector

Instructor

Cheryl Vitow

Click here for complete trainer biographies 

 

Registration Fees

$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information
 

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-13-049-L01-P. Released: 9/13. 

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

 

 

 

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BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

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Blended Curriculum Path for the CRA, CRC, and Project Manager

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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 

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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)