Reg Leader
These 2 Reg leaders' all time favorite holiday movie is Home Alone
Niurbis and Alyssa
Site Initiation Visits (SIVs) should be scheduled at least how many weeks out after Initial IRB approval?
2
DSMC
Data Safety Monitoring Committee
This document is the Statement of Investigator
FDA,1572
The minimum number of Institutional Review Board (IRB) members
5
This Reg Leader's favorite food is Tacos/arepas
Jose
Once Study Start-Up has provided the handoff form, how much time does maintenance have to complete and return form?
1 week
SUSAR
Suspected unexpected serious adverse reaction
This document refers to conflict of interest
FDF, Financial Disclosure Form
Which Ancillary reviews are added to a modification for protocol amendment submissions?
PRMC- Protocol Review and Monitoring Committee
ORA- MCA Review Group
This Reg Leader has a fear of the dark
Alyssa
After SIV, which 2 documents are combined with currently approved protocol and sent via complion for staff acknowledgement?
-SIV attendance log (provided by clinical manager)
-Protocol Training Slides (provided by Sponsor)
CAP
College of American Pathologists
This document lists each member of the study team and their duties as assigned by the trial PI.
Delegation of Authority Log
Studies that involve no more than minimal risk which do not meet any exempt criteria status may be eligible for what type of IRB review?
Expedited review
This Reg Leader's superpower would be the ability to become invisible
Niurbis
The completed Attendance Log to Regulatory is required within how many days after the SIV date?
2 days
CLIA
Clinical Laboratory Improvement Amendments
This document describes the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials.
Protocol
If the proposed research does not qualify for Exempt or Expedited Review, or involves greater than minimal risk then it will go through which IRB review?
Full Committee Review
These 2 Reg Leaders' travel dream destination is Iceland
Alyssa and Jose
What portal system is completed handoff submitted to post SIV?
Asana
ALCOA
Attributable
Legible
Contemporaneous
Original
Accurate
A document outlining possible study procedures, risks, benefits, and alternatives, along with the participant’s rights. Serves as a way of documenting the participant’s understanding of study Trial.
Informed Consent Form
This committee was created under the National Institutes of Health (NIH) is responsible for providing institutional oversight of recombinant DNA research.
Institutional Biosafety Committee (IBC)