IRB Review
The IRB should review the amount and method of payment to ensure that _____ doesn’t occur.
What is undue influence?
Which U.S. federal agency is primarily responsible for regulating investigational drugs, biologics, and medical devices used in clinical research.
What is the FDA?
What does the acronym ALCOA-C stand for?
What is Attributable, Legible, Contemporaneous, Original, Accurate, Complete?
This major revision to the international Good Clinical Practice guideline became final in the US in Sept. 2025. It emphasizes quality by design, risk-based quality management, and modern technologies and trial designs.
What is ICH E6 (R3)?
Clinical research professionals can use this electronic health record system to identify potential study participants, access relevant patient information, and communicate with members of the study team.
What is Epic?
Despite its name, this type of IRB review doesn't necessarily mean a faster turnaround. it applies to certain minimal-risk studies that fit specific regulatory categories and can be conducted by a designated reviewer rather than the full board.
What is Expedited Review?
The FDA requires safety reporting within ___ days for unexpected fatal or life-threatening suspected adverse reactions.
What is 7 calendar days?
Which of the following typically requires IRB review before it can be implemented in an ongoing clinical research study?
A. A change to the study protocol that could affect participant safety
B. A typo correction in an internal filing note
C. A change to the research team’s office location
D. Ordering additional office supplies
What is A?
(A change to the study protocol that could affect participant safety)
A clinical trial involving 14,000 newborns in Guinea-Bissau testing ________ vaccine generated international controversy when critics argued that some infants would be denied a birth dose of a proven vaccine in order to study whether vaccination should occur at birth or 6 weeks.
What is the Hapatitis B vaccine?
During the informed consent process, this technique helps confirm that a potential research participant truly understands the study by asking them to explain the key information back in their own words.
What is the teach-back method?
The IRB review criteria, commonly called the "111 criteria" map what ethical tenets?
What are the Belmont Principles?
or also acceptable to name them:
What is respect for persons, beneficience, and justice?
This is the FDA regulation that governs electronic records and signatures.
21 CFR Part 11
Studies testing an FDA-approved drug for a new indication or population can quality for this.
What is an IND Exemption?
In 2025, the FDA became concerned that participants in some gene-therepy trials weren't adequaltely told that this part of their body might be shipped to another country for genetic manipulation.
What are their cells?
A clinical research professional uses this skill to navigate difficult conversations, build trust with participants, manage workplace interactions, and respond thoughtfully rather than react emotionally.
This operates as both a Master Reliance Agreement and system for tracking review and approval for studies required to use a single IRB.
What is SMART IRB?
This is the part of the federal regulation that deals specifically with research with children.
Subpart D (of 45 CFR 46)
Double Trouble
The case of the ineligibile particpant.
In February 2025, delays in this agency's grant-review process threatened research projects studying diseases including Lyme disease, heart disease, and lung disease.
What is the NIH?
This independent review examines whether a study’s processes meet GCP, protocol, and regulatory requirements.
What is an audit?
By federal rule, the IRB should include at least one _________ and non-_________.
What is Scientist?
This office provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
What is OHRP?
Best answer.... Which of the following events during participation in a drug research study is NOT an SAE:
a) bowel perforation from routine colonoscopy
b) stroke
c) severe headache that required medication
d) death not attributed to the intervention
e) hospitalization for a-fib in a participant with history of a-fib
f) none of the above
What is C.
(c. severe headache that required medication)
You Can See Everything, a new documentary following this conficted device company founder in the weeks before she reported to prison, explores the blurred line between truth, deception, and self-presentation.
Who is Elizabeth Holmes?
This part of the job requires keeping a close eye on payments, study-related expenses, participant visits, and the protocol’s budget to help prevent costly discrepancies.