This post is sponsored by IMARC Research, Inc.
Per federal regulations, 100 percent of investigative products must be accounted for at all times so they are not used for an incorrect indication, in an incorrect way, or by someone who has not been properly trained in its use. Taking steps to ensure proper accounting can provide reassurance of patient protection and enhance data integrity. The purpose of IMARC’s newest whitepaper is to provide an in-depth look into product accountability in clinical trials and the responsibility of the research team to know the regulations. Topics covered in this whitepaper include:
- What are the consequences of incomplete or improper product accountability?
- Who is responsible for product accountability?
- When does product accountability start for an investigation?
- How is adequate product accountability assessed?
- Practical examples and case studies
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The most important part of being able to conduct a well-controlled, compliant clinical study is to ensure the entire study team has a working knowledge of the regulations and standards. Product accountability should be a concern shared by an entire research team, and knowing what “rules” apply is the first step toward compliance.
Take time to download IMARC’s newest whitepaper: “Product Accountability in Clinical Trials: The Responsibility to Know your Regs!”
