Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and...

Area of Science:

• Clinical Research
• Health Services Research
• Dental and Medical Practice-Based Research Networks (PBRNs)

Background:

• Practice-Based Research Networks (PBRNs) are crucial for generating generalizable clinical study data.
• National recruitment for PBRNs can introduce risks for Institutional Review Boards (IRBs).
• Robust infrastructure is essential for maintaining data integrity and minimizing risk.

Purpose of the Study:

• To describe the PEARL Network's infrastructure for conducting interdisciplinary dental/medical clinical studies.
• To explain how the PEARL Network ensures data integrity and generalizability.
• To address challenges of national recruitment within PBRNs concerning risk management and IRB compliance.

Main Methods:

• The PEARL Network employs an infrastructure designed to adhere to Good Clinical Practice (GCP) principles.
• A data audit trail is implemented to ensure data integrity.
• Strategies for national recruitment are utilized while maintaining study compliance and patient safety.

Main Results:

• The PEARL Network successfully implements an infrastructure supporting GCP and data integrity.
• The network demonstrates effective strategies for national recruitment in a PBRN setting.
• The described approach resolves IRB concerns regarding geography and risk management.

Conclusions:

• The PEARL Network's infrastructure facilitates generalizable clinical data collection through national recruitment.
• Adherence to GCP and robust data management are key to ensuring patient safety and minimizing IRB risk.
• This model provides a framework for other PBRNs expanding nationally.