Clinical Operations
Which role is most senior - Clinical Trial Associate, Clinical Research Associate, or Clinical Trial Manager?
Clinical Trial Manager
Biostatisticians use a lot of programming languages! Name two.
SAS, R, Python, Julia, etc.
What does "at the bench" refer to?
In the lab
GMP, GLP, and GCP are all examples of this...
Regulatory guidelines
This phase of clinical trials is considered "commercialization".
Phase 4
TLFs is a commonly used acronym, standing for this...
Tables, Lists, Figures.
What phase does the successful approval of an IND (Investigational New Drug) application initiate?
Phase I
This type of regulatory submission contains preclinical and clinical data to demonstrate a drug's efficacy and safety.
NDA (New Drug Application)
This term refers to the location where a clinical trial is conducted.
Investigator site
Name a state where a fake biometrics profile may come from.
Any state! Always approach your work with professional skepticism!
What does CHO stand for?
Chinese Hamster Ovary
This system is used to manage data and processes around deviations, CAPAs, change controls and complaints.
Quality Management System
These documents consist of detailed information regarding a trial's purpose, procedure, risks, and benefits.
Informed Consent Forms (ICFs).
This is a software application that helps streamline the process of collecting, storing, and securing data from clinical studies.
Electronic Data Capture (EDC) system.
This group works on the design and optimization of chemical compounds.
Medicinal Chemistry
A QC Chemist might work in this area, as opposed to QC Micro