The original place where study data and study observations are first recorded
What is a source document?
100
Any departure from the procedures set forth in the IRB-approved protocol and by federal regulations and institutional policies
What is a variance?
100
This team member typically documents AEs on the case report form
Who is the Research Coordinator or Research Nurse?
100
Works with the RC or DM to complete the Labels for storage document
What is the RRO post award group
100
Type of animal that scientists successfully cloned in 1997
What is a Sheep?
200
All reported data in a clinical research study must be supported by this
What is source documentation?
200
Conducting research in a way that violates federal regulations, IRB policies or local institutional policies governing such research
What is non-compliance?
200
This individual reviews and signs the AE case report form
Who is the Principal Investigator?
200
Where the RRO tools/systems such as PDS, Protocol Activation Checklist and Variance Report Forms are located online
What is the Clinical Research Resources System?
200
The name of the restaurant where the “Seinfeld” gang hangs out
What is “Monk’s”?
300
The locations where source documentation can be maintained
What are Electronic medical records, paper medical records, and research charts?
300
Failure to document consent from a study subject
What is an example of a non-compliance?
300
Where AE capturing, recording, and submission requirements are outlined
What is the protocol?
300
Develops study-specific medication orders for trials involving investigational agents
Who is the IDS/Investigational Pharmacy staff?
300
Beatles song that lasted the longest on the charts (at 19 weeks)
What is Hey Jude?
400
An example of source documentation that is not part of the medical record and is maintained in the research chart
What are subject diaries, study questionnaires, or test results from outside laboratories?
400
The RRO method for reporting any variance including a deviation, violation, and non-compliance
What is the online Variance Report form?
400
Always considered serious adverse event
What is death?
400
Used when e-mails include PHI
What is encryption?
400
The best-selling board game of all time
What is Monopoly?
500
Must include the signature and date of the person completing it when used as source documentation
What are study specific worksheets or CRFs?
500
When is a protocol deviation or violation that does not meet the criteria of an unanticipated problem reported to the IRB
What is the IRB annual renewal?
500
Reported AE grade when an AE occurs more than once during a course of therapy
What is the most severe grade of an AE?
500
3 out of 6 most frequent deficiencies that required action in 2014 FDA inspections
What are:
*Failure to follow the investigational plan and/or regulations
*Protocol deviations / violations
*Inadequate recordkeeping
*Inadequate accountability of the investigational product
*Inadequate communication with the IRB
*Inadequate subject protection - failure to report AEs and informed consent issues
500
Vivien, Knox, Pax, Zahara
What are the names of 4 of 6 of Brad and Angelina’s kids’ names?
Extra credit: Maddox, Shiloh