ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS AGRADE, Exams of Nursing

Download ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS AGRADE and more Exams Nursing in PDF only on Docsity! ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS AGRADE 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? - 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 - 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 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? - 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 - 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 - 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 subjects. Who is responsible for providing a written report to the IRB/IEC? - ANSWER>>PI 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 2. Cause of death: and a comment on its possible relationship to the suspected drug reaction What is the purpose of an initiation visit? - ANSWER>>1. To review the protocol 2. To review research site's SOPs 3. To review the blank CRFs 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 2. At least one member whose primary interest is non-scientific 3. At least one member who is independent from the Institution/trial site Which of the following is NOT one of the required elements of an informed consent form? - ANSWER>>A listing of all site personnel who will be involved in the research How can an Adverse Drug Reaction (ADR) be defined? - ANSWER>>As a noxious and unintended response to the investigational drug Who is most responsible for the appropriate monitoring of clinical trials? - ANSWER>>Sponsor You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want to see which of the following - ANSWER>>1. Unobscured original entries 2. Traceable source documents 3. An Audit trail A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a CRC allowed to do this task? - ANSWER>>Only when the CRC is a qualified physician and has been delegated this responsibility by the PI You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a Site. The first course of action you implement is that a __________ be conducted. - ANSWER>>Root Cause Analysis A subject: who has been 100% compliant thus far has forgotten to bring her medication back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate action for the investigator/clinical research coordinator to take? - ANSWER>>Document that the subject has forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or during her next visit If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution: the sponsor should - ANSWER>>1. Promptly notify the regulatory authority(ies) 2. Terminate the investigator's/institution's participation in the trial Essential documents should be retained at least ______ after the last approval of a marketing application: or formal discontinuation of clinical development of the investigational product. - ANSWER>>2 years What is the purpose of the IRB/IEC? - ANSWER>>Safeguard the rights: safety: and well-being of all trial subjects Which of the following should the investigator do FIRST if a Serious Adverse Event (SAE) occurs? - ANSWER>>Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form (ICF)? - ANSWER>>1. The person who conducted the informed consent interview 2. The subject or the subject's legal representative A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in English. The -Therapeutic Confirmatory Your Investigator wants to participate in a Phase 3 Pharmacokinetics study. Pharmacokinetic studies are commonly conducted in later phases to answer what questions? - ANSWER>>1. Food effects on bioavailability 2. Information in sub-populations such as patients with impaired elimination 3. Drug to drug interactions A trial where the treatment assignment is not known by the study participant because of the use of placebo or other methods of masking the intervention: but the study team knows - ANSWER>>Single blind A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ICH E8 considers them a special population. In designing the protocol you should expect to - ANSWER>>Include children in the general plan from the beginning Per ICH E8: methods used to evaluate patient usage of the test drug should be - ANSWER>>Specified in the protocol and actual usage documented Which trial design is used for the specific purpose of examining the interaction of A and B? - ANSWER>>Factorial design T or F- The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC)? - ANSWER>>True What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" - ANSWER>>To assess the progress of a clinical trial: the safety data: and the critical efficacy endpoints T or F- The focus of ICH E9 is on statistical principles: however: it does not address the use of specific statistical procedures or methods. - ANSWER>>True For a randomized trial: the following is true - ANSWER>>1. The procedure to be followed: the necessary documentation: and the subsequent treatment and assessment of the subject should all be described in the protocol 2. Helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments Data and Safety Monitoring Boards (DSMBs) have the power to recommend which of the following? - ANSWER>>1. That the sponsor should continue the trial 2.That the sponsor should modify the trial 3. That the sponsor should stop the trial You need to maintain the blind in a clinical study. Which of the following options might you use when administering supplies in the clinical trial? - ANSWER>>Double-dummy Which variable in a study should be used to determine the sample size? - ANSWER>>Primary variable You are writing an Investigator-initiated clinical research protocol and you need to limit the occurrence of conscious and unconscious bias. Which of the following methods may be used? - ANSWER>>1. Single-Blind 2. Masking 3. Double-Blind You are reading the findings of a clinical trial on hair loss and use of shampoo. You note in the final analysis that data was extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. This is known as - ANSWER>>Generalization The Investigator at your site asked you to review a protocol. The investigational product listed in the protocol already has proven clinical benefits for the disease under study. This is considered what type of trial? - ANSWER>>Confirmatory Trial You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns __________: that is: the residual influence of treatments in subsequent treatment periods. - ANSWER>>Carryover effect Missing data points (values) represent a potential source of bias in a clinical trial. (True or False) - ANSWER>>True What study variable takes in the consideration the decision making process of the treating physician: who must weigh benefit and risk in making product use decisions. - ANSWER>>Global Assessment Variable True or False- You are working on a Phase 1 clinical trial. The sponsor tells you that the study will be carried out in three different research centers. Multi-center trials can be carried out at any stage of clinical development. - ANSWER>>True You are helping your Investigator write a protocol for a new combination of drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator Initiated Study you know you will need to establish a/an - ANSWER>>Independent Data Monitoring Committee During clinical development: the timing of pediatric studies will depend on - ANSWER>>1. Medicinal produc 2. Type of disease being treated 3. Safety considerations 4. Efficacy and safety of alternative treatments What does ICH E11 say about long-term surveillance of children in clinical trials? - ANSWER>>It may be needed to determine the possible effects on development When each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons - ANSWER>>Crossover When subjects are randomized to 1 of 2 or more arms: each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses: and one or more control treatments: such as placebo and/or an active comparator - ANSWER>>Parallel 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 2. review the protocol 3. review the blank eCRFs: Minimum SAE reporting requirements 4. Subject details (ID not name) 5. IP 6. Interventions for the event that is being reported 7. Details of the event 8. Details on the reporter of the event 9. Admin and sponsor or company details Vulnerable subjects - ANSWER>>1. Junior members of the medical profession 2. Employees of a pharmaceutical company 3. Military personnel 4. Pregnant Women 5. Prisoners IRB/IEC Evaluates - ANSWER>>1. The rights: safety: and well- being of the subjects participating in the trial 2. The subject selection procedure 3. The scientific tenability of the trial Serious Adverse Event (SAE) - ANSWER>>1. Results in death: is life threatening 2. Requires inpatient admission 3. Prolonged admission 4. Congenital anomaly 5. Persistent incapacity 6. Death itself is not neccessarily an SAE* 7. Must be reported by sponsor to authorities within 15 calendars days from sponsors first knowledge of the event *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 2. If the reaction is possibly: probably: or definitely related to the drug: it is considered an ADR 3. All ADRs must be documented 4. ADRs are not always AEs 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 2. Can be mild moderate or severe 3. Worsening of a pre-existing medical condition is an AE Non-Clinical Study - ANSWER>>1. Not conducted on human subjects 2. Provide preliminary safety and pharmacokinetic data needed to support studies in human Data Safety and Monitoring Board (DSMB) - ANSWER>>1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints 2. Can recommend that sponsors modify: end: or continue a trial. But cannot recommend they start a new trial WMA - ANSWER>>World Medical Association 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 If a subject experiences a heart attack or other unexpected SAE that wasn't documented in the IB: Who must the event be immediately reported to? - ANSWER>>The sponsor and the IRB/IEC The study protocol does not need to include statistical analysis methods (T/F) - ANSWER>>False Subjects can be enrolled using lab results predating when the ICF was signed (T/F) - ANSWER>>True What must be done: at the site level: if the protocol is altered during the trial? - ANSWER>>the subjects must be reconsented and the irb/iec should be informed and approve the changes if the trial is to continue If a person is in a life threatening situation that necessitates the test article: and they/their LAR cannot provide consent... what must the PI do to properly enroll the subj per required measures described in the protocol? - ANSWER>>Receive documented approval/favorable opinion by the IRB/IEC prior to enrollment. Then ensure the subjs LAR is informed asap to continue the consent Pre-Trial Meetings Discuss - ANSWER>>1. subject availability 2. competing studies 3. lab requirements 4. sponsor expectations DSMB (Data and Safety Monitoring Board) - ANSWER>>1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints 2. Can recommend that sponsors modify: end: or continue a trial. But cannot recommend they start a new trial Incapacitated subjects can provide consent as soon as capacity is regained (T/F) - ANSWER>>True The signature page is a required section of the IB - ANSWER>>False All trial phases assess safety (T/F) - ANSWER>>True Focuses on safety and dose in healthy subjects Determine metabolic and pharmacologic action of the drug in humans Investigates human pharmacology The most typical study Initial administration or IND into humans - ANSWER>>Phase I Focuses on efficacy and side effects in subjects of that specific indication A study which seeks to determine the ideal dose and regimen of a new IP to treat the indicated condition - ANSWER>>Phase II Compares new tx to existing tx for that indication A study which seeks to evaluate the IP to similar treatment options or placebo if there are no current tx's for the indication Determines therapeutic benefit and is done in a larger: specific population. Can be reffered to as a therapeutic confirmatory trial: pivotol trial: or comparative efficacy trial - ANSWER>>Phase III * *Phase III trials usually have fewer subjects than Phase IV trials Therapeutic use: begins after drug approval Tx is approved and available: but still evaluating for long term effects Phase IV trials usually require more subjects and data collection than phase III trials - ANSWER>>Phase IV Post Market - 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 - 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 - 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) - ANSWER>>True Any changes to an IB are not required to be submitted to the IRB/IEC (T/F) - 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? - ANSWER>>in the study files of the PI and Sponsor