QAIP Study Initiation Visits

QAIP Study Initiation Visits are Available for New Studies That Have Received IRB Approval.

The QAIP Coordinator will provide:

• Assistance with set-up/organization of study records and required documents;
• Instruction concerning local IRB reporting requirements for:
  1. Adverse events
  2. Amendments
  3. Continuing review
  4. Data safety and monitoring reports
  5. Protocol deviations
• Education about the informed consent process and documentation
• Clarification of confidentiality and HIPAA issues.

Schedule a QAIP Study Initiation Visit If You:

• Are a new investigator or coordinator
• Are an investigator with no study coordinator
• Have questions about IRB reporting requirements
• Are not assisted/monitored by other entities (e.g. a sponsor)
• Would like assistance with study setup before enrollment begins

Study Initiation Visit: Preventive Care for Your Study Site text