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ACRP CP CERTIFICATION EXAM 2024- 2025 ACTUAL EXAM COMPLETE ACCURATE EXAM QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) /ALREADY GRADED A+
Typology: Exams
1 / 50
A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study design they will use to test the efficacy of the IP? - ....ANSWER...Non-Inferiority
What type of clinical trial most likely requires enrollment of the largest number of research subjects? - ....ANSWER...Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - ....ANSWER...5 (... lay people and medical professionals can be part of the IRB/IEC)
Who is responsible for providing the protocol - ....ANSWER...The Sponsor
The purpose of the SIV is to - ....ANSWER...1. review standard procedures
Vulnerable subjects - ....ANSWER...1. Junior members of the medical profession
IRB/IEC Evaluates - ....ANSWER...1. The rights: safety: and well-being of the subjects participating in the trial
Serious Adverse Event (SAE) - ....ANSWER...1. Results in death: is life threatening
*Seriousness does not equal severity in that Serious requires reporting while severe may not.. Severe may just be used to describe an AE
Adverse Drug Reaction (ADR) - ....ANSWER...1. All noxious and unintended response that is related to any dose
Not observed before. Or the Event occurred more often than previously observed - ....ANSWER...Unexpected Event
Adverse Event (AE) - ....ANSWER...1. Any untoward medical occurrence that does not necessarily have a causal relationship with treatment
Non-Clinical Study - ....ANSWER...1. Not conducted on human subjects
Data Safety and Monitoring Board (DSMB) - ....ANSWER...1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints
WMA - ....ANSWER...World Medical Association
Declaration of Helsinki - ....ANSWER...-Created by WMA in 1964: - Defines the ethical principles for medical research involving human subjects
LAR - ....ANSWER...Legally Acceptable Representative. (regarding consenting procedures)
International Conference on Harmonization (ICH) - ....ANSWER...Mission is to provide a unified standard for Europe: US: and Japan to facilitate the acceptance of clinical trials
Expected AEs - ....ANSWER...Those that are consistent with the product information and were present on previous and preclinical trials
Contents of the site TMF - ....ANSWER...1. IP accountability records
Per ICH: how long must an IRB/IEC keep correspondence for after the completion of a clinical trial - ....ANSWER...at least 3 years
The signature page is an optional section of the IB (T/F) - ....ANSWER...True
Incapacitated subjects can provide consent as soon as capacity is regained (T/F) - ....ANSWER...True
Who should send Annual Progress Reports to the IRB/IEC - ....ANSWER...The Investigator
The investigator is required to share names of subjects with the IRB/IEC (T/F) - ....ANSWER...False
CRAs(monitors) cannot review source documents of subjects who have withdrawn consent. Even if the source document predates their consent withdrawal(T/F) - ....ANSWER...True
When should research studies involving human subjects be registered in a publicly accessible database - ....ANSWER...before recruiting the first subject
Any changes to safety language in an IB should be submitted to the IRB/IEC (T/F) - ....ANSWER...True
All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) - ....ANSWER...True
After completion of a study: where should the final trial close-out monitoring report prepared by the CRA be filed? - ....ANSWER...in the Sponsor's files
During a multi-site clinical study: Whose responsibility is it to report subject recruitment rate?
What is the investigator's first priority when a subject wishes to withdraw prematurely from the trial? - ....ANSWER...to obtain the subject's reason for withdrawal
CRC's can't adjust IP dose: even if they are a qualified physician (T/F) - ....ANSWER...False. If a CRC is a qualified physician they can adjust IP dose
Following unblinding in the case of a suspected serious unexpected adverse drug reaction: the treatment assigned to the subject turns out to be the comparator product. Who should the sponsor inform? - ....ANSWER...The manufacturer of the product and/or the regulatory authorities
If there is a a serious unexpected adverse drug reaction in a blinded trial: when should the investigator unblind the subject? - ....ANSWER...The investigator unblinds before reporting the SUADR: in order to determine a safe treatment
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ....ANSWER...Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for - ....ANSWER...Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - ....ANSWER...maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the - ....ANSWER...ICF
What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ....ANSWER...Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate?
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and protocol therapy was initiated. The subject showed significant improvement in his clinical condition: and regained consciousness. The Investigator should inform the subject about the study and - ....ANSWER...Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has received IRB approval. The site can begin enrolling subjects
after... - ....ANSWER...A signed clinical trial agreement between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test: a research specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects? - ....ANSWER...A research assistant who is certified to administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB. What benefit information should be included in the ICF? - ....ANSWER...Wording indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - ....ANSWER...Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB? - ....ANSWER...PI
Which of the following required elements should be included in a clinical trial protocol? - ....ANSWER...Subject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study files of the - ....ANSWER...PI and Sponsor
During a monitoring visit: what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - ....ANSWER...Electronic medical record
When considering participation in a study: the investigator should determine if he... - ....ANSWER...Sees enough patients who would qualify for the study
New safety information has become available from the Sponsor about the IP being used in a clinical trial. The investigator must - ....ANSWER...Submit a revised ICF to the IRB noting the new safety information
Per ICH: an IRB must keep correspondence for at least how long after the completion of a clinical trial? - ....ANSWER...3 Years
When would an impartial witness be needed during the consent process for an illiterate subject? - ....ANSWER...To observe the consent process
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be - ....ANSWER...Phase II
After completion of a study: the final trial close out monitoring report prepared by the CRA should be filed in which of the following stakeholder files? - ....ANSWER...The sponsors files
A blood sample collection is required to screen for bloodborne pathogens before subject could be
enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? - ....ANSWER...ICF
When should a research study involving human subjects be registered in a publicly accessible database? - ....ANSWER...Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - ....ANSWER...The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the study? - ....ANSWER...Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers - ....ANSWER...Phase I
Who is ultimately responsible for all aspects of the research conducted at a site? - ....ANSWER...Principal investigator
An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of trials and credibility of data - ....ANSWER...GCP
What event resulted in the Nuremburg Cod of 1949 - ....ANSWER...Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study files of the - ....ANSWER...PI and Sponsor
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - ....ANSWER...The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? - ....ANSWER...The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment rate?
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be - ....ANSWER...Phase II
What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ....ANSWER...IB
When considering participation in a study: the investigator should determine if he/she - ....ANSWER...sees enough patients who would qualify for the study
When would an impartial witness be needed during the consent process for an illiterate subject? - ....ANSWER...To observe the consent process
During a monitoring visit: what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - ....ANSWER...electronic medical record
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test: a research-specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects? - ....ANSWER...A research assistant who is certified to administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB/IEC. What benefit information should be included in the ICF? - ....ANSWER...Wording indicating that there is no expected benefit should be included.
A research subject's responsibilities for study participation should be described in the - ....ANSWER...ICF
New safety information has become available from the Sponsor about the IP being used in a clinical trial. The Investigator must - ....ANSWER...submit a revised ICF to the IRB/IEC noting the new safety information.
A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the subject? - ....ANSWER...Consenting in the presence of figure of authority
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ....ANSWER...Try to obtain the subject's reason for withdrawal.
A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? - ....ANSWER...ICF
Per ICH: an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - ....ANSWER...3 years
A CRA notices during an onsite visit that the date on IRB/IEC approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - ....ANSWER...Confirm dates of initial receipt of the sponsor protocol and the IRB/IEC submission dates.
A CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for - ....ANSWER...validation, accuracy, reliability, and completeness.
When should a research study involving human subjects be registered in a publicly accessible database? - ....ANSWER...Before recruiting the first subject
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and
protocol therapy was initiated. The subject showed significant improvement in his clinical condition: and regained consciousness. The Investigator should inform the subject about the study and - ....ANSWER...obtain consent from the subject for the study.
After completion of a study: the final trial close-out monitoring report prepared by the CRA should be filed in which of the following stakeholder files? - ....ANSWER...The sponsor's files
A site is in the start-up phase of an industry- sponsored phase 3 trial: and has received IRB/IEC approval. The site can begin enrolling subjects after
In a multi-arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC? - ....ANSWER...PI
Part of a sponsor's responsibility pertaining to electronic trial data handling is to maintain an audit trail: data trail: and edit trail. Which entity is primarily charged with considering subject rights and well-being during clinical trials? - ....ANSWER...Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
Which of the following would be considered a vulnerable population requiring special consideration by an IRB/IEC? - ....ANSWER...1. Medical, pharmacy, dental, and nursing students:
T or F- The terms "serious" and "severe" are synonymous according to ICH - ....ANSWER...False
An Unexpected Adverse drug reaction is - ....ANSWER...A reaction that is not consistent with the applicable product information
ICH safety definitions can be found in - ....ANSWER...ICH E2A
An Adverse Event (AE) that is severe in intensity - ....ANSWER...May not meet the definition of serious
T or F- Information discovered during the course of a clinical investigation that might materially influence the benefit-risk assessment of the investigation/product may necessitate rapid communication to regulatory authorities. - ....ANSWER...True
Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a possible side effect. This is considered a/an - ....ANSWER...Serious Adverse Drug Reaction
T or F- A subject in your diabetes research study developed colon cancer: which the Investigator has determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a serious adverse event because it is life threatening.
In pre-market approval studies: all noxious and unintended responses to a medicinal product even possibly related to any dose should be considered - ....ANSWER...Adverse Drug Reaction
You were just informed that you have a research patient that is receiving intensive treatment in an emergency room for allergic bronchospasm. This should be considered as - ....ANSWER...A serious adverse event
After a Serious Adverse Event (SAE) has occurred: how should you list the subject identification on the immediate and follow-up reports? - ....ANSWER...By their subject identification number
In which scenario would unblinding typically occur? - ....ANSWER...When the investigator wants to make sure a particular subject is not randomized to placebo in the case of a Serious Adverse Event (SAE)
What is the timeframe for "expedited" reporting of serious: fatal or life-threatening: unexpected adverse drug reactions to regulatory authorities? -
....ANSWER...As soon as possible, but no later than SEVEN calendar days after first knowledge of the event
The term "severe" in ICH is used to describe - ....ANSWER...The Intensity of a specific event
All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as - ....ANSWER...Adverse Drug Reactions
Which of the following criteria is described in ICH- GCP as necessary for classifying an Adverse Event (AE) as an Adverse Drug Reaction (ADR)? - ....ANSWER...That a causal relationship is at least a reasonable possibility
A subject has a suspected serious adverse drug reaction with the outcome of death. Which are items that should be submitted to the Sponsor? - ....ANSWER...1. A de-identified autopsy report: if available
What is the purpose of an initiation visit? - ....ANSWER...1. To review the protocol
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as - ....ANSWER...Informed Consent Process
T or F- The IRB/IEC may request additional information be given to subjects when: in the judgment of the IRB/IEC: it would add meaningfully to the protection of the rights: safety and/or well- being of the subjects. - ....ANSWER...True
The IRB/IEC should consist of a reasonable number of 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 - ....ANSWER...1. At least five members