Essential Components of a Clinical Trial Agreement

This webinar is the first in a series on intensive programs on reviewing and negotiating clinical trial contracts between drug and device companies and hospitals and medical practitioners.

We will provide an overview of a clinical trial contract, introducing major components of a clinical trial contract as well as the players (entities or individuals) that may be involved in getting a clinical trial agreement to execution including who are parties to the contract. The webinar will discuss the scope of the project and sponsor, CRO and site responsibilities along with payment terms, timeline/schedule, termination provisions, and how to address disputes.

Content level: All Levels

Learning Objectives: 

1. Identify the main components and types of clinical trial agreements.
2. Comprehend effective negotiation skills and techniques to achieve mutually beneficial outcomes.
3. Avoid or resolve potential conflicts or disputes that may arise during or after the contract execution.

Speakers: David D. King, SRAI Distinguished Faculty, Retired, Senior Associate University Counsel, University of Louisville; J. Michael Slocum, JD, SRAI Distinguished Faculty, President, Slocum & Boddie, PLLC; Amanda B. Tassa, Of Counsel, Slocum & Boddie, PLLC

Individual Registration Fees - Member: $99 | Non-member: $165; Unlimited Group Registration Fee: $350

Clinical trials can involve significant risks and liabilities for research sponsors, investigators, and sites, as well as for study participants who may suffer injuries or adverse events as a results of their participation. Therefore, it is essential for those who are involved in drafting, reviewing, negotiating, or supervising the performance of clinical trial agreements to understand the legal and practical aspects of indemnification, subject injury, and insurance clauses. These clauses can determine who is responsible for paying for the costs of diagnosing, treating, compensating, or defending against claims arising from study-related injuries or damages and other risks including intellectual property infringement, violations of the privacy of subjects and other third parties, the appropriateness of study protocols, and future publications and representations made about study protocols and results. While not frequently litigated, indemnification clauses often provide the framework for addressing who will pay particular costs resulting from claims related to the clinical trial.

This webinar will review the types and scope of indemnification clauses in clinical trial agreements, provide strategies and challenges for negotiating indemnification clauses, and review the sources of subject injury clauses. We will also discuss strategies and challenges for negotiating subject injury clauses, the types and scope of insurance clauses, logistics and procedures for making or responding to a claim for indemnification for subject injury coverage, and issues related to Medicare Secondary Payor rules and equity for the non-insured for those trials for which CMS allows payment of a device or other costs.

Content level: All Levels

Learning Objectives: 

1. Identify strategies for negotiating indemnification and subject injury clauses.
2. Identify issues related to Medicare Secondary Payor rules.

Speakers: David D. King, SRAI Distinguished Faculty, Retired, Senior Associate University Counsel, University of Louisville; J. Michael Slocum, JD, SRAI Distinguished Faculty, President, Slocum & Boddie, PLLC;

Individual Registration Fees - Member: $99 | Nonmember: $165; Unlimited Group Registration Fee: $350

The entire purpose of a clinical trial is to generate a record of the safety and efficacy of the drug or device being evaluated. The record is key to FDA approval, clinical director for use, and often times, a central issue in many types of litigation - from IP disputes to mass torts related to adverse effects.

Clinical trials generate a large amount of data and documentation that must be properly managed, stored, and protected throughout the study and beyond. This webinar will provide an in-depth analysis of the best practices and regulatory requirements for record-keeping, document ownership and control, inspection, and privacy in clinical trial contracts.

Content level: All Levels

Learning Objectives: 

1. Identify and classify the essential documents for clinical trials and understand their purpose and function.
2. Apply the best practices and regulatory requirements for managing, storing, and protecting clinical trial data and documents.
3. Prepare for and handle audits and inspections by regulatory authorities or sponsors.

Speakers: Debra Parrish, Partner, Parrish Law Offices, LLC; J. Michael Slocum, JD, SRAI Distinguished Faculty, President, Slocum & Boddie, PC

Individual Registration Fees - Member: $99 | Nonmember: $165; Unlimited Group Registration Fee: $350

Clinical trials are essential for developing new drugs and medical devices that can improve health outcomes and quality of life. However, they also involve complex intellectual property issues that can affect the rights and interests of the parties involved, such as sponsors, investigators, institutions, participants, regulators, competitors, and the public. This webinar will provide a comprehensive overview of the intellectual property issues in clinical trials.

Content level: All Levels

Learning Objectives: 

1. Learn strategies and challenges protecting and commercializing intellectual property in clinical trials.
2. Learn the roles and responsibilities of the parties involved in managing intellectual property in clinical trials.
3. Learn about recent security and bio-security issues arising from new US and EU guidance on improper foreign influence and national security threats.

Speakers: Debra Parrish, Partner, Parrish Law Offices, LLC

Individual Registration Fees - Member: $99 | Nonmember: $165; Unlimited Group Registration Fee: $350

Historically, when payors saw that patients were enrolled in clinical trials, they declined to cover many routine costs of care and presumed many costs were associated with the clinical trial. This led to many sponsors excluding older participants who may have a variety of medical conditions. To encourage device and drug manufacturers to include Medicare beneficiaries in clinical trials, a law was passed wherein Medicare (and Medicare Advantage Organizations), would cover not only routine costs that would have been covered absent a clinical trial, but would also cover a portion of the costs of the clinical trial and medical complications that might arise from such participation. In this webinar, we will learn how savvy sponsors and institutions conduct analyses of the costs of a clinical trial and bill Medicare for medical services when possible.

Content level: All Levels

Learning Objectives: 

1. How to qualify a clinical trial for Medicare coverage of certain costs.
2. How to minimize the chances that clinical trial costs will prompt an audit of a facility's billing practices.

Speakers: Debra Parrish, Partner, Parrish Law Offices, LLC

Individual Registration Fees - Member: $99 | Nonmember: $165; Unlimited Group Registration Fee: $350

Clinical trials produce valuable data and knowledge that can benefit the scientific community and the public. However, they also raise complex legal and ethical issues related to the publication and dissemination of study results. In addition, there are issues involving the confidentiality of the data and interaction with the health care provider regarding protected health information, the management of study data, and the source documents including the subject medical records and any needed data sharing for verification/reproducibility. This webinar will provide an overview of the best practices and regulatory requirements for publication and data issues (confidentiality and data management) in clinical trial contracts.

Content level: All Levels

Learning Objectives: 

1. Understand and apply the principles and standards for sharing clinical trial data with various stakeholders.
2. Identify and address the legal and ethical issues related to publication rights, authorship, peer review, data quality, data ownership, intellectual property rights, data sharing agreements, and open access policies.
3. Implement the best practices and regulatory requirements for ensuring the confidentiality, security, integrity, accessibility, and preservation of study data.

Speakers: David D. King, SRAI Distinguished Faculty, Retired, Senior Associate University Counsel, University of Louisville; Karen Mullin, J.D., LL.M., Senior Legal Counsel, The Chartis Group, LLC

Individual Registration Fees - Member: $99 | Nonmember: $165; Unlimited Group Registration Fee: $350

Research misconduct is the bane of the research community. It destroys trust in science and the promise of science which should be the search for truth. This betrayal is most keenly and immediately felt when researchers conducting a clinical trial do not have integrity. The fallout for an institution when research misconduct is found during a clinical trial is significant. This webinar will explore which of those ethical breaches in the context of a clinical trial rise to the level of research misconduct and which do not (at least in the United States). We will explore these concepts through a review of illustrative cases finding research misconduct.

Content level: All Levels

Learning Objectives: 

1. Identify which problems in clinical trials rise to the level of research misconduct and the follow therefrom.
2. Understand the civil and criminal causes of action against lower level researchers and principal investigators who commit research misconduct in a clinical trial.

Speakers: David D. King, SRAI Distinguished Faculty, Retired, Senior Associate University Counsel, University of Louisville; Debra Parrish, Partner, Parrish Law Offices, LLC

Individual Registration Fees - Member: $99 | Nonmember: $165; Unlimited Group Registration Fee: $350