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
- Identify and classify the essential documents for clinical trials and understand their purpose and function.
- Apply the best practices and regulatory requirements for managing, storing, and protecting clinical trial data and documents.
- 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, PLLC
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