Quality and Design Control
R&D and Biostats
"HTP"
Histology, Pathology and Tissue
Histology, Pathology and Tissue
Clinical and Regulatory
PMO
BD and Marketing
200
This is the reason GLPs were implemented.
A) Scientists were fabricating results
B) Companies did not know what studies had been conducted
C) Equipment was not maintained
D) All of the above
D) All of the above
200
These refer to anything that may effect a specimen before actual testing (eg. staining) begins.
A) What are pre-analytical variables?
B) What are determinate variables?
C) What are processing variables?
D) What are QC criteria?
A) What are pre-analytical variables?
200
This term is used for cancer tissue that has not broken through the basement membrane and has not invaded the surrounding tissue.
What is an in situ cancer?
200
This branch of FDA reviews Agilent's CDx PMA submissions.
Hint: The answer is not CDER.
What is CDRH? (Center for Devices and Radiological Health)
200
Person assigned to organize, plan and oversee the execution of project objectives.
Who is the project manager?
200
Nina Green mentioned this will be engraved on her tombstone.
What is "Vision without execution is hallucination"?
400
This package insert contains the hazard labelling that must accompany a product.
A) What is the Global Harmonization Standard (GHS) Insert?
B) What is the Safety Data Sheet (SDS) insert?
C) What is the Instructions for Use (IFU)?
A) What is the Global Harmonization Standard (GHS) Insert?
400
The width of this interval decreases as the sample size increases.
A) What is a sample size metric?
B) What is a confidence interval?
C) What is a normalized distribution?
B) What is a confidence interval?
400
The primary cause of antigenicity loss during sample preparation in Histology prior to IHC staining.
What are Heat & Time? (A combination of sample exposure to high temperatures and times exposed to those high temperatures decreases antigenicity)
400
In an external study, this is the name of the process where a site will stain several batches of slides but not evaluate them between staining iterations.
A) What is batch processing?
B) What is "Stain and Hold"?
C) What is clinical bridging?
D) What is prospective testing?
B) What is "Stain and Hold"?
400
A visual representation of the project’s schedule of events in the order of their occurrence.
What is a timeline?
400
The acronym MFA stands for this.
What is "Master framework agreement"?
600
Risk is estimated by assigning scores for these two parameters for the occurrence of harms.
A) What is Severity and Probability?
B) What is Harm and Severity?
C) What is Harm and Probability?
A) What is Severity and Probability?
600
This type of testing is done to evaluate the assays staining performance when operating outside of the assay’s standard conditions.
A) What is a precision study?
B) What is a stability study?
C) What is robustness testing?
D) What is external reproducibility?
C) What is Robustness testing?
600
This kind of cell gets its name from hand jewelry.
A) What is a ruby ring cell?
B) What is a tiara cell?
C) What is a signet ring cell?
D) What is a bracelet cell?
C) What is a signet ring cell?
600
This document written by Clinical Affairs is used to demonstrate the clinical performance of a product intended to be available in the European Economic Area under IVDR and may contain clinical performance studies, scientific peer-reviewed literature, and published experience gained by routine diagnostic testing.
A) What is a CPR?
B) What is an SSP?
C) What is an Investigator's Brochure?
D) What is a PSUR?
A) What is a CPR? (Clinical Performance Report)
600
Uncertainties that can positively or negatively impact a project’s objectives.
What is risk?
600
CDx Business Development uses this software to manage business opportunities.
What is Clarizen?
800
According to TP31677, ‘Design Reviews and Phase Reviews,’ design reviews should be conducted at these two phases, at minimum.
A) What are Design Output Phase and Design Transfer and Design Validation Phases?
B) What are Design Input Phase and Design Transfer and Design Validation Phases?
C) What are Design Input Phase and Design Output Phases?
A) What are Design Output Phase and Design Transfer and Design Validation Phases?
800
In this type of study, comparisons are made to consensus.
A) What is a clinical trial?
B) What is a precision study?
C) What is a robustness study?
D) What is a stability study?
B) What is a precision study?
800
This step during IHC staining has the highest risk of tissue falling off the slide.
A) What is heat-induced epitope retrieval (HIER)?
B) What is tissue fixation?
C) What is Proteolytic-induced epitope retrieval (PIER)?
D) What is Endogenous Enzyme Blocking?
A) What is heat-induced epitope retrieval (HIER)?
800
This study-specific electronic system is used to capture staining and evaluation data in an Agilent-sponsored external study.
A) What is Agile?
B) What is NordiQC?
C) What is Agile EDC?
D) What is Veeva CDMS/EDC?
D) What is Veeva CDMS/EDC?
800
A completed event or significant change in stage in a project’s work plan.
What is a milestone?
800
This online resource is offered on Agilent's website and provides PD-L1 practice cases for Pathologists.
A) What is Targos?
B) What is Agilent Center of Excellence?
C) What is the Online Atlas of Stains?
D) What is Staining Training?
C) What is the Online Atlas of Stains?
1000
This is a systematic method used in the Human Factors Engineering process to produce a detailed description of the sequential manual and intellectual activities of personnel using a device.
A) What is Formative Evaluation?
B) What is an Hierarchical Task Analysis (HTA)?
C) What is Use Scenario?
B) What is an Hierarchical Task Analysis (HTA)?
1000
Stability is determined as where the regression confidence interval intersects with this threshold.
A) What is a consensus standard?
B) What is a stability minimum limit?
C) What is the allowable drift limit?
D) What is a regression confidence threshold?
C) What is the allowable drift limit?
1000
The process where one type of mature, differentiated cell changes into another type of mature, differentiated cell that is not normally found in that tissue. This transformation usually occurs as an adaptive response to chronic irritation or inflammation.
A) What is polyplasia?
B) What is metaplasia?
C) What is metastatic cancer?
D) What is mitosis?
B) What is metaplasia?
1000
The IVDR transition deadline for conformity assessment of Class C CDx IVDs was postponed to this month and year.
A) What is May 2026?
B) What is December 2027?
C) What is December 2028?
D) What is May 2029?
C) What is December 2028?
1000
When a project’s executed activities extend beyond the original work plan (and may prompt a change request)?
What is scope creep?
1000
This medical affairs activity gathers Key Opinion Leaders in a pre-launch setting to provide feedback on the device scoring algorithm and commercialization plan.
A) What is the Pathologist Advisory Counsil?
B) What is the NordiQC?
C) What is Pathology-CDx launch committee?
D) What is the AACR planning workshop?
A) What is the Pathologist Advisory Counsil?