Alphabet Soup
The act of reviewing the medical record for protocol compliance
What is SDR?
P values are my thing
Who is Biostats
Cornerstone for one?
What is a Training Plan?
Defined as a critical process on every imaginable interventional study
What is informed consent collection
Robust Protocol Synapsis is complete
When should I start RBQM?
RBQM?
What is Risk Based Quality Management?
Builds a lot of fields
Who is Data Management
Summarizes activities when outsourcing a GxP activity
What is a Service Provider Oversight Plan?
Critical data for every imaginable interventional study
What is the primary endpoint
First site is activated
When RACT should be finalized by?
Reduces the error rate by 0.26% and therefore is considered of low value and will likely be discontinued in the long term
What is SDV
AE? that's me
What is Safety?
This type of control utilizes leading indicators designed to detect risks
What are Key Risk Indicators?
Tumor growth, survival time, blood pressure; one of these is not a critical data field
What is blood pressure
Protocol amendment
When to update the RACT
RACT?
What is Risk Assessment Categorization Tool?
Primary, secondary? I define those
Who is Medical Director?
This control strategy utilizes predetermined limits to identify study issues
What are Quality Tolerance Limits?
Programmed check to ensure that an assessment was performed within the protocol-defined window
What is an edit check
Control strategies are presented to leadership
When is SOURCe 2
CtQ?
What is Critical to Quality? (Factors)
Ultimately responsible for RBQM
Who is everyone on the SMT
Monitoring pooled data for trends
What is central monitoring
Absence of errors that matter
What is quality
Daily Double!!!!
See Prompt