ACRP Certified Professional Exam Questions and Answers
In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:
Who is responsible for the ongoing safety evaluation of the IP?
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?
A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?
The PI may assign responsibility for IP accountability to the pharmacist provided they are:
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?
All site financial matters pertaining to a trial are listed in what document?
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?
Which of the following activities is the MOST efficient way of overseeing a CRO’s management during a clinical trial?
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?
In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?
During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:
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?
An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?
A root cause analysis should be:
Source data/documentation should be:
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
The inclusion and exclusion criteria are in place so all subjects are:
Which of the following elements of the Informed Consent are NOT required?
Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?
Which document confirms the PI’s agreement to permit auditing at the study site?
The investigator/institution should permit:
A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?
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?
While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?
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?
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
After the completion or termination of a clinical trial, who should store the enrollment log?
A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?
Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?
A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?
Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?
A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?