Research
Individuals who provide ancillary services, routine or intermittent care who are not acting outside their normal scope of duties
Who is NOT listed on the DOA log?
Federal agency that oversees the Export Administration Regulations (EAR)
What is the Commerce Department?
OIG
What is Office of Inspector General?
Sending emails securely containing PHI externally
What is encryption?
Prior to engaging in the activity
What is it when you submit an Outside Professional Activity (OPA) request?
This must occur not less than once per year or at intervals appropriate to the degree of risk
When must IRB review occur?
Comprehensively sanctioned country geographically located close to Florida, with a pre-COVID thriving tourist industry
What is Cuba?
Supervisor/Manager, Internet, Hotline, In person
What is a way you can report a compliance issue (name at least one method)?
HIPAA
What is the Health Insurance Portability and Accountability Act?
A time commitment
What is reviewed in an Outside Professional Activity (OPA)?
A departure from the IRB-approved protocol that identifies a change after the fact: contraindicates instructions in the IRB-approved protocol
What is a deviation?
Laws and regulations put in place by the federal government to restrict the release of equipment , chemical or biological materials, information, technology, software, source code, or services to a foreign country
What are export controls?
Disposal of PHI
What is locked shred bin used for?
Any paid or unpaid professional activity with or for any person or entity other than Moffitt which is not part of a Team Member’s duties and responsibilities
What is an Outside Professional Activity (OPA)?
The form that the investigator signs verifying that they have the experience and background needed to conduct the clinical trial according to FDA regulations and guidelines
What is Form 1572?
The transfer of controlled technology, information, equipment, software, or services to a foreign person in the U.S. or abroad
What is an export?
What are three areas of Moffitt’s Corporate Compliance Department?
PHI
What is Protected Health Information?
$5,000 over 12 months
What is the minimum threshold for reporting an SFI?
The policy that allows for billing routine care associated with clinical trials when certain criteria are met
What is the Medicare Clinical Trial Policy NCD 310.1?
The regulation distinction that allows universities and research institutes to conduct research without having to apply for an export control license
What is fundamental research?
Name, Address, Birth date, SS#
What are some examples of PHI?
Unauthorized access or disclosure of PHI for any reason other than treatment, payment, or healthcare operations
What is a breach?
What is issued by the Compliance Office when an investigator has received between $5,000 and $10,000 from an entity funding their research
What is an Actionable Financial Interest Memorandum (AFI)?