Adverse Events
An adverse event is classified as "serious" if it meets one of these FDA-defined criteria — name at least two.
What is death, life threatening, hospitalization, disability/incapacity OR congenital anomaly?
This valve pumps blood from the left atrium to the right ventricle.
What is the mitral valve?
This FDA exemption allows investigators to use an unapproved medical device in a clinical study to collect safety and effectiveness data required for a future marketing submission.
What is an Investigational Device Exemption? (IDE)
This principle of good documentation states that data must be Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.
What is ALCOA-C?
This is the color of the NEW building at Riverside Methodist Hospital.
What is Teal?
This person assesses relatedness.
Who is the Principal Investigator? (PI)
This consists of the brain and spinal cord.
What is the Central Nervous System? (CNS)
Medical devices are classified into three risk-based categories by the FDA. This highest-risk category requires Premarket Approval (PMA).
What is a Class III Medical Device?
Under ICH E6 GCP guidelines, essential trial documents and source records must be retained for a minimum of this many years after the last marketing approval.
What is 2 years?
SBAR, Power Words, Empathy Statements, STAR, 56-Second Connection, for example.
What are the HRO Universal Skills?
This document describes the expected safety profile of an investigational drug or device and is used to assess whether an adverse event is "expected" or "unexpected."
What is an Investigator's Brochure? (IB)
DAILY DOUBLE!!
This class of medications ends with the suffix -artan.
What is an ARB?
Under 21 CFR Part 812, this signed document defines each party's responsibilities in conducting an IDE device trial and must be executed between the sponsor and an investigator before a site can enroll its first participant.
What is the Investigator Agreement?
This software is used in clinical trials to electronically collect, manage, and store patient data.
What is an EDC?
This person recently sent us a video about his/her "Favorite Day at Work."
Who is Steve?
DAILY DOUBLE!!
An adverse event not previously identified in nature, severity, or frequency in the investigator's brochure or informed consent form is classified as this type of event.
What is an Unexpected Adverse Event? Or Unanticipated Adverse Device Effect?
This is a treatment for cancer. (Sorry folks I don't know much about cancer).
What is chemo?
This type of IDE is a limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication.
What is an early feasibility trial?
This document, maintained by the research site, contains all essential documents required to reconstruct and evaluate a clinical trial — including delegation logs, consent forms, and correspondence.
What is the Regulatory Binder or Investigator Site File? (ISF)
What is Silver?
This is the 5 letter acronym for the grading system used to categorize the severity of adverse events in clinical trials.
What is CTCAE?
This disease occurs when plaque builds up in the arteries that supply blood to your heart.
What is Coronary Artery Disease?
This type of IDE trial is a study in which a device for a specific indication is evaluated for the first time in human subjects.
What is an FIH or FIM study? (First in Human, First in Man)
The goal of this clinical trial phase is to determine the long-term safety and efficacy needed to assess the risk-benefit relationship of the drug or device.
What is a Phase III Clinical Trial?
We love when this food truck comes to visit.
What is Schmidt's?
DAILY DOUBLE!!