In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.
Per federal regulations, 100% 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. Failure to account for and manage study materials could affect the acceptability of the data collected from a trial, or even termination of a study completely. Both sponsors and investigators have responsibility over device accountability and can be held accountable if problems are identified.
Taking steps to ensure proper accounting can provide reassurance of patient protection and enhance data integrity. The purpose of IMARC’s 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
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 whitepaper: “Product Accountability in Clinical Trials: The Responsibility to Know your Regs.”