CORRECT ANSWERS - - CORRECT ANSWERS - ALREADY GRADED A+ What are ex...

ACRP CCRC ACTUAL Exam 300 QUESTIONS AND

CORRECT ANSWERS -

ALREADY GRADED A+

What are expected or possible consequences of over-estimation of recruitment potential? - CORRECT ANSWER-- The trial will overrun its projected timeline

• The recruitment period will be prolonged and more sites may be needed
• The study will not have sufficient data within the required timeframe and will be stopped because

of lack of budget

What should be the first consideration when conducting a clinical trial? - CORRECT ANSWER- Subject welfare

When is the investigator allowed to deviate from the protocol? - CORRECT ANSWER-When there is an immediate hazard to a patient.

If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? - CORRECT ANSWER-- The Sponsor

- IRB/IEC

• Regulatory Authorities

Which conditions should be fulfilled when enrolling a subject into your trial? - CORRECT ANSWER-- Subject meets all inclusion criteria

• Subject has given written informed consent

You've been delegated to handle the storage and inventory of IP. The study drug must be stored below 25C/77F. On a summer Monday morning you discover that the temperature recording machine in the storage room has failed so you doin't know what the temperature has been over the weekend. You check the current temperature; it's 24C/75F. What should you do? - CORRECT ANSWER-- Contact the Sponsor, explain what happened and ask for instructions

• Set up a site staff meeting to conduct a root cause analysis

A protocol amendment was issued for a trial. Your site received IRB approval for the amendment and wants to implement the increase in PO dose for your trial subjects as identified in the amendment trial subjects. As delegated consenting duties you must re-consent trial subjects before 1 / 4

being able to administer the adjusted dose. You decide to only re-consent trial subjects who are still taking the IP and not from the subjects woh already completed their drug intake period. Is this allowed according the E6 Guideline for GCP? - CORRECT ANSWER-No, these subjects are still enrolled in the trial and therefore need to be updated on any changes to the protocol.

A trial subject informs you she no longer wants to participant in the trial. What should your course of action be? - CORRECT ANSWER-You ask if the patient wishes to share the reason why she wants to leave the trial. If not, you exclude the subject from the trial immediately.

A patient cannot recall the name of the heart condition medication he took a few years ago. This is important information for deciding whether the patient may be enrolled in a clinical trial (IC/EC).What's your best course of action? - CORRECT ANSWER-You attempt to retrieve the patients medical history by contacting previous caregivers and you wait for additional information before enrollment.

Who has ultimate trial responsibility for each subject? - CORRECT ANSWER-The principle investigator.

A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? - CORRECT ANSWER-No

What statements are true concerning an adverse drug reaction? - CORRECT ANSWER-- All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR

• An ADR suggests a relationship to trail medication
• All ADRs must be documented

What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - CORRECT ANSWER-- Any AE that results in death

• Any AE that results in inpatient hospitalization
• Any AE that is a congenital anomaly

During a study visit a patient tells the investigator that she visited an emergency room and received intensive treatment for allergic bronchospasm. Since the patient was in the emergency room for only three hours, the investigator did not assess the event as serious. Is this a correct assessment? - CORRECT ANSWER-No, this would be a medically important event and should be considered serious 2 / 4

What data points minimally need to be reported by the site when reporting an SAE, so that the sponsor can process the event? - CORRECT ANSWER-Identification of event, product, and trial subject

During a visit with investigator, a subject reported feeling heart palpitations for a brief period of time during the previous evening. The heart palpitations resolved without reoccurrence. The investigator considered these symptoms to be unrelated to study drug. The next day, the subject told a fellow student that he felt tired and was planning on taking a nap. Later, the subject was found dead. A preliminary report from the medical examiner indicated the subject died of pulmonary embolism.What should your next course of action be? - CORRECT ANSWER-- Record these events in case report form

• Immediately notify sponsor about serious adverse events

When asked by a regulatory body why they received SAE related information on 12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason being they received the trial related SAE information from the investigator in 12/2013. Is the sponsor correct in only holding the investigator accountable for their late reporting? - CORRECT ANSWER-No, the sponsor should support the conduct QC activities with the sites to help them ensure timely SAE reporting.

A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator considers this event possibly related to the study drug even though this is not listed in the IB as a potential adverse reaction. What would the investigator report this event to the sponsor as? - CORRECT ANSWER-An unexpected, serious adverse event

A 22y/o male was entered into a clinical study for treatment of schizophrenia The study drug was administered orally, BID. One week later, the subject visited the investigator complaining of sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug. How should this severe throat be classified? - CORRECT ANSWER-- An adverse event

• An adverse drug reaction

In regards to AE and ADR reporting, what statements are true? - CORRECT ANSWER-- All ADRs are AEs but not all AEs are ADRs

• Worsening in pre-existing medical conditions is an AE

-Preplanned hospitalization is usually not an SAE

What determines the causality of an adverse event? - CORRECT ANSWER-The investigator 3 / 4

Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? - CORRECT ANSWER-Quality improvement

Which term best describes an independent assessment of completed work to ensure it will meet applicable quality standards? - CORRECT ANSWER-Quality assurance

Which term best describes the activities done to ensure quality output? - CORRECT ANSWER- Quality control

Which term requires structure and a definition of acceptable standards of performance? - CORRECT ANSWER-Quality planning

Which is represented in ALCOA-C? - CORRECT ANSWER-Attributable

What does CAPA stand for? - CORRECT ANSWER-Corrective and Preventive Action

When not completed correctly, which is a major contributing factor to an ineffective CAPA plan? - CORRECT ANSWER-Root cause analysis

What are the cyclical activities performed a part of quality improvement? - CORRECT ANSWER- Plan, Do, Check, Act

What is sued to determine root causes? - CORRECT ANSWER-- Fishbone diagram

• Process flow charts
• The 5 Whys

What are fishbone diagrams, process flow charts, and the 5 whys used for determining? - CORRECT ANSWER-Root causes

What is the key difference between quality improvement and quality assurance activities? - CORRECT ANSWER-Can be performed by persons involved in doing the work.

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