Year Published: 2014

Time to Complete: 55 min

Instructor: Fred Frankhauser, JD, MBA, RPh

Learning Level: Fundamental

Primary Audience: Researchers

Prerequisite: None

Skills Domain: Study and Site Management


What is the purpose of a clinical trial agreement? What does a researcher need to know before signing an agreement?

The content in this course was presented in 2016 at Tufts Medical Center, as part of the 20-hour course entitled Demystifying Cancer Clinical Trials.

Learning Objectives

After completing this course, you will be able to:

  • Describe the importance of the contract process in the research lifecycle
  • Discuss the ins and outs of the contract process
  • Explain the best practices of the contract process as it relates to research

Course Outline

  • Different Types of Agreements
  • Agreements in Investigator-initiated vs. Sponsor-initiated Studies
  • Budget Items in Industry-Funded Research Projects
  • Other Cost to Consider in a Clinical Trial Budget
  • Contractual Terms in Clinical Trial Agreements
  • Intellectual Property (IP) and Publication Rights
  • Negotiating for Publications –Scenario I
  • Negotiating for Publications –Scenario II
  • Confidentiality and HIPPA
  • Negotiating IP by Study Type
  • Indemnification
  • Subject Injury Responsibilities
  • Conflict of Interest (COI) & Different Policies

Resources

  • Lecture Slide Deck (PDF)

Course Evaluation

  • Post-Course Evaluation
  • Course Completion Verification

 

 This Course is Free