Latest Exam Prep

QUESTION 59
When designing a clinical trial, why is it important to define the study population?

QUESTION 60
When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

QUESTION 61
Who must be blinded in a double-blind study in order to prevent bias?

QUESTION 62
An impartial witness should be present during the entire informed consent discussion when:

QUESTION 63
A PI is reviewing the CRF for a recent subject visit and notices the participant’s heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

QUESTION 64
A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

QUESTION 65
Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

QUESTION 66
After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

QUESTION 67
Which document confirms the PI’s agreement to permit auditing at the study site?

QUESTION 68
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

QUESTION 69
All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

QUESTION 70
Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

QUESTION 71
A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

QUESTION 72
The IB contains which of the following sections?

QUESTION 73
A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

QUESTION 74
Who is responsible for submitting a protocol amendment to the IRB/IEC?

QUESTION 75
A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

QUESTION 76
Per protocol, participants are scheduled to receive IP, which is calculated based on the participant’s current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant’s safety?

QUESTION 77
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

QUESTION 78
The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

QUESTION 79
A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

QUESTION 80
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

QUESTION 81
A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

QUESTION 82
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?