Understanding and Applying Best Practice Standards When Reviewing Clinical Research Contracts

Why Should You Attend:

Understanding contract terms and provisions is essential to ensuring the interests of participants, sites and sponsors are detailed, agreed upon and protected. Contracts define everything from: who owns what data, who can use the data, what protections are offered in the event of injury to a participant to when and how payments are made and who is responsible for ensuring all compliance report criteria are met.

Clinical research contracts outline legal obligations of the study team and site, and legal limitations of protections, understanding these provisions leads to more effective communication between the business administrators responsible for oversight of the study and the legal representatives for the site and the sponsor who are responsible for negotiating terms.

This webinar will provide a robust knowledge of terms and understanding of common concerns as well as best practices in clear and understandable non-legal language. The instructor’s extensive knowledge and experience in clinical research administration, including contract review, and development makes her well suited to answer your questions and offer guidance in best practices for ensuring contracts are compliant with the highest standards of best practices.

Learning Objectives:

• Identify each type of contract
• Describe who is being protected
• Understand provisions that comprise standard sections of a contract following best practice standards

Areas Covered in the Webinar:

• Types of clinical research agreements
• Elements of a CTA
• Who is being protected and how
• Understanding how contracts and protocols fit together
• Who should participate in the review and why
• When sites are non- profit, what differs

Who Will Benefit:

• Investigators
• Coordinators
• Health System Administrators
• Clinical Research Compliance Staff/ Officers
• Industry Managers and Monitors
• Business and Finance Administrators

Instructor Profile:

Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. She is currently consulting privately. Ms. Holcomb has worked in nationally accrediting Institutions with AAHRPP. Her experience also includes serving in executive leadership roles at research institutions including Duke University, UCHealth System and University of Louisville. She provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Her key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Ms. Holcomb has extensive experience in training and education and served as Vice Chair of the ACRP Professional Development Committee for 4 years.

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