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UPCOMING LIVE SEMINARS
 






Writing Clinical Study Reports for Diagnostic Studies

Upcoming Courses
Course #: BI11567
June 2, 2014
2:30 PM - 4:00 PM Eastern
$695.00
Course #: BI11665
July 22, 2014
12:00 PM - 1:30 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 Clinical Study Reports (CSRs) for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these CSRs, the guidances to follow for reference, basic skills for understanding the data (i.e., false positives, false negatives, and percent agreement), and other diagnostics output and results, as well as coordination with the 510(k) submission.

Learning Objectives

  • Turn the protocol and data into clear concise submission documents
  • Describe the elements required for the CSR and how this differs from standard pharma CSRs
  • Differentiate between the types of data and their interpretation
  • Describe where the CSR fits into a 510(k) submission and some interdependencies

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#: 0778-0000-13-051-L01-P. Released: 10/13. 

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

 

 

 

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Web SeminarWEB SEMINARS

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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)