Acronymns
Binder Contents
SIV Roles
Don’t forget to bring...
100
SIV
What is Site Initiation Visit?
100
Cannot initiate study activities prior to receiving this.
What is IRB Approval?
100
Comes prepared with sign-in log and reg reporting questions
What is the Regulatory Specialist?
100
Sometimes sponsor brings one, sometimes RS brings one.
What is the SIV Attendee Log?
200
CPRC
What is Cancer Protocol Review Committee?
200
$$$$
What are Financial Disclosure Forms?
200
Comes prepared with lab collection questions
What is the CRC?
200
The draft should have been prepared at CCPM
What is the DOA Log?
300
AURPC
What is All-University Radiation Protection Committee?
300
Statement of Investigator
What is a Form 1572?
300
Comes prepared with questions regarding schedule of procedures
What is the CRC-RN?
300
Is often anthropomorphized
What is the Florence eReg binder?
400
CCPM
What is Clinical Care Planning Meeting?
400
Timeline of reviews often affect IRB approval.
What are ancillary review approvals?
400
Hosts the local SIV
What is a program manager
400
Sponsor is eager to receive these, but some might be pending.
What are outstanding regulatory documents?
500
RAPO
Required Activities Prior to Opening
500
This document includes a "FWA number"
What is the IRB registration letter? (sometimes called IRB Roster or Membership letter)
500
Has to attend, even if grudgingly
What is the PI?
500
Rename your name in Zoom if needed