Eye See What You Did There!
This part of the eye controls the amount of light entering it.
What is the iris?
According to ICH-GCP, who is ultimately responsible for the conduct of a clinical trial at a site?
Who is the Principal Investigator (PI)?
All source documents must follow what set of standards?
What is ALCOA-C? (Attributable, Legible, Contemporaneous, Original, Accurate, Complete)
According to ICH-GCP, what three key elements must be present for informed consent to be considered valid?
What are information, comprehension, and voluntariness?
If a subject forgets to take their eyedrops, this is called what?
What is noncompliance?
This jelly-like substance fills the space between the lens and the retina.
What is the vitreous humor?
This document outlines the delegation of trial-related duties at a site and must be kept up to date throughout the study.
What is the Delegation of Authority Log (or Site Delegation Log)?
This system is used to enter study data electronically.
What is the EDC?
This document outlines all required assessments and procedures for each study visit.
What is the Schedule of Events, or Visit Schedule?
This term means all critical tasks must be done exactly as the protocol says.
What is protocol adherence?
This disease is the leading cause of irreversible blindness worldwide.
What is glaucoma?
In which phase of a clinical trial is the primary objective to determine the optimal dose and evaluate preliminary efficacy in a small patient population?
What is Phase II?
In ophthalmic trials, this test is often used to assess visual acuity.
What is the ETDRS chart test? (Early Treatment Diabetic Retinopathy Study charts)
During a screening visit, a subject is found to be ineligible after labs are reviewed 2 days later. Study drug was already administered. What GCP principle was violated?
What is verifying eligibility before enrollment (GCP compliance regarding subject protection and protocol adherence)?
A subject calls to say they are experiencing serious vision changes. What type of event might this be?
What is a serious adverse event?
The macula is part of this layer of the eye.
This term describes when neither the participant nor the investigator knows the treatment assignment.
What is double-blind?
This type of protocol deviation must be reported to the IRB.
What is a significant or major deviation?
A subject verbally agrees to participate in a study but is unable to physically sign due to a disability. According to GCP, how can consent be legally obtained?
What is through use of a legally authorized representative (LAR)?
A protocol amendment is issued mid-study that changes the dosing schedule. One subject continues on the old schedule due to a missed communication. What is this situation classified as, and what is the site's responsibility?
What is a protocol deviation. The site must document the event, notify the sponsor and IRB as required, and retrain relevant staff to prevent recurrence.
The optic disc lacks photoreceptors and is often called this.
What is the blind spot?
This international guideline, often abbreviated as ICH E6(R3), outlines ethical and scientific standards for designing, conducting, recording, and reporting clinical trials.
What is the International Council for Harmonisation Guideline for Good Clinical Practice?
This type of error occurs when clinical data entered into the EDC system doesn't match the source documentation, and must be corrected through a formal process.
What is a data discrepancy or query?
FINAL JEOPARDY CATEGORY: VISION FOR THE FUTURE. MAKE YOUR WAGERS!
Clue:
Your ophthalmic clinical trial site is considering integrating emerging digital tools (like mobile apps or remote imaging devices) to improve data collection and patient monitoring. However, these tools raise new concerns about patient privacy and data security. What key factors should your site evaluate before adopting these technologies, and how should these considerations influence your informed consent process and overall trial conduct?
FINAL JEOPARDY ANSWER: DO NOT SELECT until final jeopardy reveal