Adverse Reactions
This term describes any untoward medical occurrence in a participant, whether or not related to the investigational product.
What is an Adverse Event (AE)?
Any change from the protocol is called this.
What is a protocol deviation?
This person ensures that the trial is conducted and documented properly by performing routine site visits.
Who is the clinical research associate (CRA)?
Like The Matrix, blinded participants may be taking the real thing or a ____?
What is a placebo?
Which document outlines all known expected adverse reactions?
What is the Investigator's Brochure (IB)?
True or False: All deviations must be reported to the sponsor.
What is True?
DAILY DOUBLE!!!!!!!
Wager before showing the clue.
During monitoring, this process ensures data in the CRF matches original records.
In Finding Nemo, Marlin obsesses over safety. He'd love this document that lays out all potential risks and procedures.
What is the ICF?
A participant experiences an AE that is listed in the investigator brochure and expected in frequency and severity. What classification does this fall under?
What is an expected adverse event?
This document is used by investigators to record and explain protocol deviations and their impact on the study.
What is a deviation log?
According to GCP, monitors must verify that this group has approved the protocol before the first participant is enrolled.
What is the Institutional Review Board (IRB) or Ethics Committee (IEC)?
In The Hunger Games, participants are randomly selected - just like this process in clinical trials.
What is randomization?
This staff member went to high school with three people who either worked on or starred in Gilmore Girls.
Who is Mark?
DAILY DOUBLE!!!!!
Wager before revealing the clue.
This regulatory term refers to a serious AE that is unexpected and related to the study drug.
A participant is dosed outside the protocol-defined visit window, but no harm occurred. True or false: This is not a reportable deviation.
What is False. It should be documented as a protocol deviation.
This type of visit typically occurs after the study has ended to ensure all study materials are accounted for and properly stored or returned.
What is a close-out visit?
In Men in Black, agents erase memories - just like what you shouldn't do to original data in a source document. What's the correct method instead?
What is a single line through the error, initial, date, and note the correction?
True or false: Only the PI can determine the relatedness of an AE.
What is True?
Using white-out on a source doc? Regulatory nightmare called...?
What is data falsification?
If a CRA finds that a site staff member is performing study duties without delegation, it's a violation of this log.
What is the delegation of authority log?
In Inception, there's a dream within a dream. In research, this type of study compares results within the same group across time.
What is a crossover study?