Ongoing Financial and Regulatory Management and Study Closeout

Content
6 modules

Rating

Course Length
15 mins

Instructor
Advarra University

Price
Free

Description

This course covers the fundamental concepts and processes for managing study amendments, maintaining regulatory compliance within clinical trials, ongoing financial management responsibilities and expectations for clinical trials, and conducting study closeout.

Attendance at this program has been approved for 0.50 contact hours of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 0.50 hours of CE credit.

Objectives

By the end of this course, learners will be able to:

  • Understand the purpose and operational impact of study amendments in a clinical trial
  • Communicate responsibilities for regulatory compliance in study conduct, training, and financial operations
  • Understand ongoing financial events, roles, and processes in a clinical trial
  • Manage and delegate responsibilities and tasks for proper study closeout

Certificate

By completing/passing this course, you will attain the certificate Advarra Completion Certificate (No Expire)

1.
Introduction to Study Amendments
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2.
Managing Study Amendments
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3.
Maintaining Regulatory Compliance
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4.
Financial Management of the Trial
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5.
Study Closeout
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6.
Quiz
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