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ACRP CP FINAL EXAM 2025 /2026| BRAND
NEW ACTUAL EXAM WITH 100% VERIFIED
QUESTIONS AND CORRECT ANSWERS
Post Market - correct answer - - Analysis conducted after drug approval aka Phase IV: - Provides the most significant amount of safety and efficacy in pediatrics trials with ltd. Number of participants Pediatric Trials - correct answer - - can be prepared for by developing a program for use in children: - experience with use in children so far should be included in the development plan: - conduct pharmacodynamic/pharmacokinetic studies in children if there is no relevant information available from similar compounds Study design must include - correct answer - - clear endpoints: - Appropriate comparators: - Adequate # of subjects All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) - correct answer - True
Any changes to an IB are not required to be submitted to the IRB/IEC (T/F) - correct answer - False. changes to safety language must be submitted to the IRB Prior to archiving a study: where should documentation of site IP destruction be filed? - correct answer - in the study files of the PI and Sponsor Centralized monitoring supports clinical data review by examining data trends (T/F) - correct answer - True A site is in the start-up phase of an industry-sponsored phase 3 trial: and has received IRB/IEC approval. When can the site begin enrolling subjects? - correct answer - after a signed clinical trial agreement between the site and sponsor is in place A randomised controlled trial ( RCT ) that lets you carry out 2 or more treatment comparisons at the same time. while multiple factors are manipulated - correct answer - Factorial Study
CSR - correct answer - - Clinical Study Report: - To summarize study methods: results and conclusions typically using appropriate statistical analyses: - To account for all subjects and all data: using tables and graphs: including p values: - To draw conclusions What do sensitivity analyses test? - correct answer - data robustness - needed to estimate treatment risk and benefits for larger population Data Vulnerabilities - correct answer - - Data variations: - Confounders Gathers data without a hypothesis stated before starting trial - correct answer - Exploratory Trial Expected to provide strong clinical data evidence about safety and efficacy. - correct answer - Confirmatory Trial
Trials tests if stated hypothesis: created before trial: is supported or not - correct answer - Confirmatory Trial The study of how the organism effects the drug for the duration of exposure - correct answer - Pharmacokinetic Trial Examines the drug's effect on the organism for the duration of exposure - correct answer - Pharmacaodynamic Trial Provides a specific treatment to study its impact on cancer. - correct answer - Therapeutic Trial Characteristics of "Robust Data" - correct answer - - clean: - complete: - precise: - protocol has been followed The degree of certainty in the sampling method - correct answer - Confidence Interval - The wider the CI: the more data variability
Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to - correct answer - maintain an audit trail, data trail, and edit trail. A research subject's responsibilities for study participation should be described in the - correct answer - ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - correct answer - Investigators brochure During a multi site clinical study: whose responsibility is it to report subject recruitment rate? - correct answer - The CRA 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 - correct 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... - correct 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? - correct 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? - correct answer - Wording indicating that there is no expected benefit should be included
When considering participation in a study: the investigator should determine if he... - correct 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 - correct 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? - correct answer - 3 Years When would an impartial witness be needed during the consent process for an illiterate subject? - correct 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 - correct 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? - correct 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? - correct answer - ICF When should a research study involving human subjects be registered in a publicly accessible database? - correct answer - Before recruiting the first subject In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - correct 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? - correct answer - Consenting in the presence of figure of authority
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - correct answer - The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct answer - The subject inclusion and exclusion criteria During a multi-site clinical study: whose responsibility is it to report subject recruitment rate? - correct answer - The CRA A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be - correct answer - Phase II What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - correct answer - IB
When considering participation in a study: the investigator should determine if he/she - correct 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? - correct 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? - correct 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? - correct 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? - correct answer -
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? - correct answer - ICF Per ICH: an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - correct 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? - correct 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 - correct answer - validation, accuracy, reliability, and completeness.
When should a research study involving human subjects be registered in a publicly accessible database? - correct 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 - correct 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? - correct 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 - correct answer - a signed clinical trial agreement between the site and sponsor is in place. In a multi-arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of breast cancer in the
ICH safety definitions can be found in - correct answer - ICH E2A An Adverse Event (AE) that is severe in intensity - correct 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. - correct 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 - correct 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.
- correct answer - False In pre-market approval studies: all noxious and unintended responses to a medicinal product even possibly related to any dose should be considered - correct 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 - correct 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? - correct answer - By their subject identification number In which scenario would unblinding typically occur? - correct 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)
