Essential Components of a Clinical Trial Agreement | Webinar Series

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.

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.

Knowledge Level: All Levels

Individual Registration:
Member Price: $99
Non-Member Price: $165