A patient is paid a $100 flat rate per study Visit.
What is a stipend.
This board reviews and approves research involving human subjects.
What is the Institutional Review Board (IRB).
What does PSV stand for.
What is 'Pre-site Visit'
This document provides participants with key information about a study.
What is a consent form.
This cancer center provides care to patients from all 99 counties in Iowa and the surrounding area.
What is the Holden Comprehensive Cancer Center.
Wendy Beaver Leads this department and is responsible for contract signing on behalf of the University.
What is the Division of Sponsor Programs.
An unapproved drug used in a clinical study is called this.
What is an investigational drug.
What does TREC stand for?
What is 'Trial Resource Evaluation Committee'
This must be disclosed if it could affect a participant’s decision to enroll.
What are risks.
This Iowa family’s $25 million donation led to the cancer center being named in their honor.
Who is the Holden family.
The group who processes charge matching for trials.
Who is Research Billing Compliance.
Approval required before beginning many FDA-regulated clinical trials.
What is an IND (Investigational New Drug application).
Documents needed to complete a MOG form.
What is a completed sponsor questionnaire and full protocol.
Information that can identify an individual.
What is identifiable data.
This year marks the official establishment of the University of Iowa’s cancer center, which would later become the Holden Comprehensive Cancer Center.
What is 1980.
This is the initial payment the sponsor provides once the trial is Open to Accrual.
What are the Start-up fees.
Adverse events that are unexpected, related, and serious must be reported as this.
What is an unanticipated problem.
How often does TREC meet?
What is every other Wednesday at 8:15 am.
This group requires additional regulatory protections.
Who are vulnerable populations.
This Iowa-based coalition of health professionals, caregivers, researchers, and community members has worked with Holden for years to reduce the statewide burden of cancer.
What is the Iowa Cancer Consortium.
This document is needed to process the final close out audit and requested upon notice of a study closing out.
What is the final reconciliation spreadsheet.
Failing to obtain IRB approval before starting research is considered this.
What is noncompliance.
This committee negotiates the CDA.
Who are the Division of Sponsor Programs and the Sponsor.
This federal law protects medical information used in research.
What is HIPAA.
This major early 2000s research grant, awarded jointly to Holden and Mayo Clinic, supported groundbreaking work in lymphoma research.
What is the SPORE grant.