Cancer Clinical Trials Office

A team of regulatory affairs specialists, regulatory affairs coordinators and compliance coordinators in the Cancer Clinical Trials Office provides regulatory guidance about policies and procedures to investigators, study teams and internal review committees. The regulatory team may also review protocols to ensure accurate and complete regulatory information.

The Cancer Clinical Trials Office ensures high-quality standards for data collection and clinical trials management. The office has quality-management resources to maintain patient safety and high-quality clinical trials operations while proactively providing real-time feedback to staff, improving audit outcomes and furthering staff collaboration.

Regulatory services include:

• Submitting regulatory documents and reporting adverse events to Mayo Clinic committees and external agencies.
• Submitting and maintaining U.S. Food and Drug Administration (FDA) investigational new drug and device applications.
• Supporting an electronic regulatory binder system used by investigators and study teams.

Compliance services include:

• Planning and implementing compliance activities.
• Interpreting and applying regulatory and policy requirements.
• Helping develop and plan education programs for Mayo Clinic and external collaborators.

Quality assurance services include:

• An internal monitoring and auditing program for investigator-initiated trials. These services include:
  • Reviewing and comparing data entered into a data capture system against information in patient source documents to ensure protocol compliance and data integrity.
  • Reviewing regulatory documentation to ensure that requirements are met for the Institutional Review Board, good clinical practices and the FDA.
  • Conducting meetings or exit interviews with principal investigators and study teams to discuss findings.
  • Writing reports for monitoring or auditing.
• First- and third-subject and regulatory reviews designed to help identify educational or procedural gaps, or both, across studies and study teams.
• Assisting with electronic data capture system testing.
• Performing data reviews, data queries and data cleaning of the electronic data capture system.
• Other quality reviews to ensure proper reporting and submission of complete documentation about adverse events and deviations to the Institutional Review Board.