Human Research Protections Office (HRPO)

Industry Sponsored Research

Research that is industry sponsored means that a commercial entity contributes to the design or conduct of the study (as evidenced by a sponsor's protocol, sponsor's identification number and/or Investigator's brochure); coordinates the study as a multi-center trial; reimburses UMB or a UMB Investigator for costs associated with conducting the trial; or will have access to, or publish or present the data gained from conducting the trial. All investigators should contact the Center for Clinical Trails (CCT) to negotiate the CCT agreement before initiating the study.

For protocols that are Industry Sponsored the following tools should be used to assist in developing and conducting your research:

• Continuing Review Table to Report SAE's (MSWord)
• BRAAN Protocol Format (PDF)
• Data and Safety Monitoring Plan (MSWord)
• General Requirement of Informed Consent (PDF)
• HIPAA Authorization Form (MSWord)
• ICH Guidance for Industry - E6 GCP (PDF)
• Inclusion/Exclusion Checklist (MSWord)
• Industry Sponsored Billing Form - Less Than $10,000 (MSWord)
• Industry Sponsored Billing Form - Greater Than $10,000 (MSWord)
• IRB Regulatory Compliance Letter (PDF)
• New Protocol Checklist (MSWord)
• Sample Letter of Invitation-Phone Interview (MSWord)
• Sample Letter of Invitation-Survey (MSWord)
• QI Self Assessment Tools (MSWord)
• Evaluation to Sign Consent Form  (PDF)
• Tools & Tips for Writing a Clear and Appropriate Informed Consent Document  (PDF)
• Tips to Help Avoid a Protocol Bounce Back (MSWord)
• Data Use Agreement (PDF)
• Obtaining Human Research Data Under HIPAA (PDF)
• Delegation of Responsibility Log (MSWord)
• Tips for Submitting Renewals (PDF)
• Economic Interest Disclosure (MSWord)

Printer friendly    Email this page