Clinical Trial Contracts

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

This course examines institutional clinical trial contractual agreements, and how budgets, regulations, and law compliance impacts study conduct.  The session discusses specific research agreement terms, particular to pre-study initiation and post study activation, and their impact on successful contract and budget negotiations.   

Topics:

1. Elements of a Sponsored Research Agreement
   • Confidential Information
   • Patient Privacy/ Use of Protected Health Information (PHI)
   • Publication
   • Protection of Inventions
   • Indemnification
   • Subject Injury Reimbursement
2. Compliance with Contract Terms Impacting Study Conduct
   • Case Report Form (CRF) Reporting
   • Principle Investigator Change
   • Adverse Event Reporting
   • Monitoring
   • Record Storage
3. Budgeting Terms
   • Medicare Secondary Payor Act (MSP)
   • State Law Requirements
   • California law SB-37
   • Federal Anti-Kickback Laws (Stark Law)
   • Arm’s length transaction and Fair Market Value (FMV)
   • Referral Payments
   • False Claims Act

Speakers: 

Melissa Archer, J.D., is director of the Keck School of Medicine of USC Clinical Trials Office since February 2016.  Her work has been focused on clinical trials for the past 8 years of her career and she previously served as a Principal Contract Officer at Cedars-Sinai Medical Center. Prior to that, she spent the majority of her career as a medical malpractice and hospital litigation attorney in the Tampa Bay Area. She is a graduate of the University of Florida and Stetson University College of Law. Melissa.archer@med.usc.edu

Sara Katrdzhyan has been a part of the USC family since 2010 when she joined USC’s Clinical Trials Office (CTO) as a contract manager, responsible for negotiating contracts and budgets for industry sponsored clinical trials. Currently, she oversees the contracts group at the CTO responsible for negotiating all clinical trial agreements in addition to overseeing various responsibilities of the pre-award team to ensure the timely activation of industry sponsored clinical trials at USC. Sara’s educational background includes a Bachelor of Science in Business and Management from the University of Redlands, and a Master of Studies in Law from USC, Gould School of Law.

Audience:

This symposium is designed for Clinical Research Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with at least 3 years of clinical research experience.  Individuals should be experienced with research study coordination, IRB submission process, budgeting, research compliance, recruiting, enrolling, financial management, data collection and analysis. 

Learner Level: Intermediate

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.  Attendees to this CNE activity will be awarded 1.25 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the third course in a six session program. To complete the entire program and earn badge Click Here. 

Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz

·       Complete the evaluation at the end

Certificates will be distributed at the end of the evaluation.

Enduring Materials Dates:

·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027