Finance
IRB & FDA Basics
Pre-Study
Consent, Risk, Privacy
HCCC Basics
100

A patient is paid a $100 flat rate per study Visit. 

What is a stipend. 

100

This board reviews and approves research involving human subjects.

What is the Institutional Review Board (IRB). 

100

What does PSV stand for. 

What is 'Pre-site Visit'

100

This document provides participants with key information about a study.

What is a consent form. 

100

This cancer center provides care to patients from all 99 counties in Iowa and the surrounding area.

What is the Holden Comprehensive Cancer Center. 

200

Wendy Beaver Leads this department and is responsible for contract signing on behalf of the University.

What is the Division of Sponsor Programs. 

200

An unapproved drug used in a clinical study is called this.

What is an investigational drug. 

200

What does TREC stand for?

What is 'Trial Resource Evaluation Committee'

200

This must be disclosed if it could affect a participant’s decision to enroll.

What are risks. 

200

This Iowa family’s $25 million donation led to the cancer center being named in their honor.

Who is the Holden family. 

300

The group who processes charge matching for trials.

Who is Research Billing Compliance. 

300

Approval required before beginning many FDA-regulated clinical trials.

What is an IND (Investigational New Drug application). 

300

Documents needed to complete a MOG form.

What is a completed sponsor questionnaire and full protocol.

300

Information that can identify an individual.

What is identifiable data. 

300

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. 

400

This is the initial payment the sponsor provides once the trial is Open to Accrual. 

What are the Start-up fees. 

400

Adverse events that are unexpected, related, and serious must be reported as this.

What is an unanticipated problem. 

400

How often does TREC meet?

What is every other Wednesday at 8:15 am.

400

This group requires additional regulatory protections.

Who are vulnerable populations. 

400

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. 

500

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. 

500

Failing to obtain IRB approval before starting research is considered this.

What is noncompliance. 

500

This committee negotiates the CDA. 

Who are the Division of Sponsor Programs and the Sponsor.

500

This federal law protects medical information used in research.

What is HIPAA. 

500

This major early 2000s research grant, awarded jointly to Holden and Mayo Clinic, supported groundbreaking work in lymphoma research.

What is the SPORE grant. 

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