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UPCOMING LIVE SEMINARS
 
Monitoring Clinical Drug Studies: Beginner
August 26-28, 2014
Philadelphia, PA
Clinical Project Management: Advanced
September 10-11, 2014
San Diego, CA






Essential Documentation in Clinical Trials at Research Sites

Upcoming Courses
Course #: BI11796
November 17, 2014
1:00 PM - 3:00 PM Eastern
$695.00

Course Description

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.

Learning Objectives

  • Define clinical research essential documentation
  • Determine essential subject and non-subject specific documentation requirements per trial
  • Discuss essential documentation for drug vs. device vs. combination products
  • Prepare for regulatory inspection: Proactive and reactive use of essential documentation

Who Should Attend

  • Clinical Research Coordinators
  • Principal Investigators
  • Research Site Managers
  • Clinical Research Associates
  • Quality Assurance Personnel
  • Project Managers
  • Clinical Research Associate Managers

Instructor

This course will be taught by one of the following instructors:

Linda Carter, R.N., B.S.N.

Nikki Christison, B.S., C.C.R.A.

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 2.5 hours (0.25 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#: 0778-0000-14-056-L01-P. Released: 11/14. 

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