RRT 200: Clinical Trial Regulatory and Financial Startup

Content
8 modules

Rating

Course Length
25 mins

Instructor
Advarra University

Price
$95.00

Description

This course covers the initial steps required to identify and begin a clinical trial. You will also learn the fundamentals of protocol feasibility, handling staff and service providers, managing a draft budget and contract, and how to handle IRB submissions.

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 primary steps of the study activation process
  • Communicate roles and responsibilities for the regulatory and financial startup of a clinical trial
  • Define and contextualize what a coverage analysis is in the early stage of a trial
  • Understand core financial startup processes and guidelines

Certificate

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

1.
First Steps
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2.
Protocol Feasibility
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3.
Preparing Your Site
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4.
Aligning Service Providers
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5.
Negotiating the Budget
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6.
Finalizing the Contract and Setting Up Accounts
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7.
IRB Submissions & Study Launch
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8.
Quiz
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