Acronym Abyss
SAE
What is Serious Adverse Event?
The Investigator’s Brochure must be signed by the CRA.
Trick (Only the PI acknowledges receipt.)
The 1572 is required for:
All U.S. sites under FDA jurisdiction
Why would a participant need an impartial witness?
If they can't read or write.
What is the purpose of a TMF?
Demonstrate GCP compliance
EDC
What is Electronic Data Capture?
A deviation that affects patient safety must always be reported to the sponsor.
Trial (Safety first!)
What are the two documents needed from a Site that get included in the IND submission?
1572 and PI CV
What word is used instead of baby in NBI ICFs?
Newborn
Missing documents in the TMF may lead to…
Inspection findings
DCSM
What is Document and Clinical System Management?
The TMF only needs to be complete at study close-out.
Trick (Must be contemporaneous.)
Name three documents in the EDP Pack?
IB/Sig page
Protocol/Sig Page
1572
FDF
19
What folder number are Monitoring Visit Reports filed at?
05.04.03
VOAL
What is Vendor Oversight and Accountability Log?
The ICF version must match the IRB-approved version.
Trial (Always double-check version control.)
What does FPFV mean?
First Participant First Visit
During monitoring, you discover subjects signed a superseded version of the ICF. What must happen?
Re-consent the subjects on the current approved version, and document a protocol deviation.
What site-level documents need to be stacked in our Veeva Vault?
CVs and Medical Licenses for site staff
HEOR
What is Health Economics and Outcomes Research?
Source data verification can be skipped if the site is busy.
Trick (Nice try.)
If a Sub-I answers Yes to a question on the FDF, what do you do?
Bias Minimization Documentation
A non-English-speaking subject signed the English ICF because the translated version wasn’t ready. What’s the issue?
Invalid consent — subjects must sign an IRB-approved ICF in a language they understand.
IP Shipment Package includes:
IRT Drug Shipment Request Email Notification
IP Packing List
Temperature Monitoring Report
IRT Drug Shipment Receipt Email Notification