Clinical Trials 101-ish
This phase of a clinical trial typically involves healthy volunteers and tests for safety and dosage
What is Phase 1?
This company sponsors Tylenol, a common over-the-counter pain reliever found in most medicine cabinets.
What is Johnson & Johnson?
This process ensures that event assessments are unbiased and based on standardized definitions.
What is adjudication?
This audit-friendly record shows who did what and when in the system.
What is the audit trail?
The document that outlines how a clinical trial will be conducted.
What is the protocol?
This company sponsors the blockbuster diabetes and weight loss drug Ozempic
What is Novo Nordisk?
This document defines the adjudication process, roles, decision criteria, and workflows
What is the charter?
Judi uses this to notify reviewers when an event is ready for their assessment.
What is an email?
This is the term for the group of participants that receives the experimental treatment.
What is the treatment group?
This immune-modulating biologic, Humira, brought in billions in annual sales before biosimilars entered the market.
What is Abbvie?
This group of experts reviews clinical events to determine if they meet pre-defined criteria.
What is the committee?
When an event is ready for final review after multiple adjudications, this step confirms consensus or escalates disagreements.
What is the committee meeting?
A type of trial where neither the participants nor the researchers know who is receiving the treatment.
What is double-blind?
This sponsor brought us Keytruda, a widely used immunotherapy for cancer.
What is Merck?
This term describes a situation where CEC members do not know which treatment a subject received.
What is blinded review?
This ensures Judi knows which fields to display, which forms to launch, and how to route events through the workflow.
What is metadata?
The regulatory body in the U.S. that oversees clinical trials for drugs and devices
What is the FDA?
Known for sponsoring Lipitor, once the best-selling drug in the world.
What is Pfizer?
In an endpoint adjudication system, this term refers to the fully assembled packet of source documents and data that reviewers assess.
What is the dossier?
To maintain compliance, Judi must be validated to prove they function as intended under regulatory standards
What is system validation or 21 CFR Part 11 compliance?