Abbreviations
IRB stands for
What is the Institutional Review Board?
Who do fast fact sheets help the most? PIs, sponsors, nursing staff, or CRCs?
Nursing staff
Who is responsible for creating the Fast Fact Sheet?
CRC
Fast Fact sheets are usually __ pages long
1-2 pages
PK stands for
What is Pharmacokinetics?
Fast Fact Sheets are for patients on clinical trial receiving research treatment/study IP through which 2 routes?
Oral and IV
What materials do CRCs need to create a Fast Fact Sheet?
Current fast fact sheet template, Current IRB approved protocol, ERICA access
When must the FFS be drafted by?
Prior to the date of the SIV
VS stands for
What is Vital Signs?
Are Fast Fact Sheets patient specific or protocol specific?
Protocol specific
Where will the CRC submit the FFS draft?
UBox
When must the FFS be reviewed?
At the SIV
SIV stands for
What is Site Initiation Visit?
Where are Fast Fact Sheets most commonly needed/used by nursing staff?
Infusion and inpatient spaces
When should timing of vital signs, ECGs, PKs be included in the FFS?
When a flowsheet is not provided by the CRC
When must the FFS be finalized?
By the time the trial is open to accrual
ERICA stands for
Trick question - both safety and quality
What are some elements of a FFS?
Basic description of the trial, purpose of the trial, common side effects and potential AEs, reactions, prohibited meds/activities
If a new protocol amentment is approved by thte IRB, how long does the CRC have to update the FFS?
1 week from approval