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ACRP CP FINAL EXAM AND PRACTICE EXAM QUESTIONS 2024-2025 ACTUAL EXAM COMPLETE ACCURATE EXAM QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) /ALREADY GRADED A+
Typology: Exams
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What information must be provided to subjects regarding their participation, according to 46/116(b)?
Participation is voluntary and they may discontinue at any time without penalty or loss of benefits
What must be included in the informed consent process when research involves more than minimal risk?
An explanation of whether compensation and medical treatments are available if injury occurs
For research involving identifiable private information or biospecimens, what must be included in the informed consent?
A statement about whether identifiers might be removed and whether the information could be used for future research without additional consent
According to 46/116(b), informed consent must include a statement regarding:
The expected duration of the subject's participation
If alternative procedures or courses of treatment are available, what must be included in the informed consent?
A disclosure of appropriate alternatives that might be advantageous to the subject
Which statement about participation must be included in the informed consent?
Subjects may discontinue participation at any time without penalty or loss of benefits
According to 46/116(b), what must be included in informed consent regarding the potential benefits of the research?
A description of any benefits to the subjects or to others that may reasonably be expected from the research
According to 46/116(b), informed consent must include contact information for:
Whom to contact for answers to questions about the research, the subject's rights, and in the event of a research-related injury
Which of the following elements must be included in informed consent if relevant to the research, according to 46/116(b)?
Any additional costs to the subject that may result from participation in the research**
What must be included in informed consent when research involves risks to an embryo or fetus?
A statement that the procedure may involve unforeseeable risks to the subject or to the embryo or fetus if the subject is or may become pregnant
In the event of new findings during the course of the research, what should be communicated to the subjects?
Significant new findings that may affect the subject's willingness to continue participation should be provided to the subject
According to 46/116(b), under what circumstances can a subject's participation be terminated without their consent?
If the investigator determines it is necessary based on anticipated circumstances
For research subject to HHS regulation at 45 CFR 46, what must be included in the consent form regarding biospecimens?
A statement regarding whether biospecimens may be used for commercial profit and whether the subject will or will not share in this profit
What must the informed consent include if the research might include whole genome sequencing of biospecimens?
A guarantee that only partial genome sequencing will be conducted
What should be communicated in informed consent about disclosing clinically relevant research results?
A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
What information must be provided regarding the consequences of a subject's decision to withdraw from the research?
A description of the procedures for orderly termination of participation and any consequences of withdrawal
Sponsor - ....ANSWER...The ____________ is responsible for the ongoing safety evaluation of the investigational product.
The sponsor's designated representative. - ....ANSWER...The review and follow-up of the monitoring report with the sponsor should be documented by:
The scientific and/or clinical knowledge needed to monitor the trial adequately - ....ANSWER...According to ICH GCP Monitors should be appointed by the sponsor. These monitors should be appropriately trained, and should have what else?
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 informatiom 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
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. - ....ANSWER...Treatment Emergent
An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments. - ....ANSWER...treatment effect
A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. - ....ANSWER...Surrogate Variable
A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). - ....ANSWER...Superiority Trial
Document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. - ....ANSWER...Statistical Analysis Plan
Represents the degree to which overt adverse effects can be tolerated by the subject. - ....ANSWER...Tolerability
The medical risks to a subject, usually assessed in a clinical trial by laboratory tests, vital signs, clinical adverse events, and other safety tests. - ....ANSWER...Product Safety
A set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol deviations. - ....ANSWER...Per Protocol Set
The level of grouping of included terms typically used in reporting frequency of occurance. - ....ANSWER...Preferred Term
The lowest level of dictionary term to which the investigator description is coded. - ....ANSWER...Included Term
A trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo control). - ....ANSWER...Non-inferiority Trial
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. - ....ANSWER...Multicenter Trial
A formal evaluation of the quantitative evidence from two or more trials bearing on the same question - ....ANSWER...Meta-Analysis
any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial - ....ANSWER...Interim Analysis
The property of yielding equivalent results when used by the same rater on different occasions - ....ANSWER...Intra-rater reliability
The property of yielding equivalent results when used by different raters on different occasions. - ....ANSWER...inter-rater reliability
the direction of the contrast differs for at least one level of the factor - ....ANSWER...Qualitative interaction
The magnitude of the contrast differs at the different levels of the factor - ....ANSWER...Quantitative Interaction
The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment. - ....ANSWER...Intention-To-Treat Principle
Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g.
treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. - ....ANSWER...Bayesian Approaches
The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalising the planned analysis. - ....ANSWER...Blind Review
The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure. - ....ANSWER...Content Validity
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active). - ....ANSWER...Double-Dummy
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol. - ....ANSWER...Dropout
A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. - ....ANSWER...Equivalence Trial
Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation. - ....ANSWER...Frequentist Methods
The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomised subjects by minimal and justified elimination of subjects. - ....ANSWER...Full Analysis Set
The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. - ....ANSWER...Generalisability, Generalisation
A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. - ....ANSWER...Global Assessment Variable
An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. - ....ANSWER...Independent Data Monitoring Committee (IDMC)
The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. Bias introduced through deviations in conduct is referred to as 'operational' bias. The other sources of bias
listed above are referred to as 'statistical'. - ....ANSWER...Bias (Statistical & Operational)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. - ....ANSWER...Adverse Event (or Adverse Experience)
all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. - ....ANSWER...Adverse Drug Reaction (ADR)
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). - ....ANSWER...Unexpected Adverse Drug Reaction
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. - ....ANSWER...Applicable Regulatory Requirement(s)
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. - ....ANSWER...Approval (in relation to Institutional Review Boards)
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). - ....ANSWER...Audit
Any public or private entity or agency or medical or dental facility where clinical trials are conducted. - ....ANSWER...Institution (medical)
the sponsor and the investigator/institution - ....ANSWER...The financial aspects of the trial should be documented in an agreement between:
A reasonable time - ....ANSWER...How long should the IRB/IEC take to review a proposed clinical trial and document its views in writing?
Critical Process and Data Identification, Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, Risk Reporting - ....ANSWER...What are the elements of the risk-based approach of quality management system?
An individual or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. This could be data management and/or monitoring. - ....ANSWER...Contract Research Organization (CRO)
Monitoring Plan - ....ANSWER...According to ICH GCP what is addendum in monitoring?
To document that tests remain adequate throughout the trial period - ....ANSWER...According to ICH GCP what is the purpose of updates of medical/laboratory tests?
subject(s), investigator(s), monitor, and, in some cases, data analyst(s) - ....ANSWER...According to ICH GCP double blind usually refers to the _________________ being unaware of the treatment assignment(s).
discontinuation criteria - ....ANSWER...ICH GCP states the protocol should generally include stopping rules for individual subjects, parts of trials and entire trial. What other term does it specify in addition to Stopping Rule?
Traceable - ....ANSWER...According to ICH GCP Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be _____________, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).
investigator - ....ANSWER...As per ICH GCP section 4.5 compliance to protocol, the _____________ should document and explain any deviation from the approved protocol.
All three - ....ANSWER...According to the Monitor's Responsibilities section of ICH GCP which of the following should be clearly reported on the CRF: 1. A visit that subject fails to make 2. Tests that are not conducted 3. Examinations that are not performed
For a period of at least 3-years after completion of the trial - ....ANSWER...According to ICH GCP for how long the IRB/IEC should retain all relevant records?
The sponsor file only - ....ANSWER...Where should final trial close-out monitoring report be filed?
The sponsor file only - ....ANSWER...Where should the audit certificate be filed?
The sponsor file only - ....ANSWER...During the clinical conduct of the trial where should new batches of certificate of analysis of investigational product(s) be filed?
Protocol, investigators brochure, and in the product information - ....ANSWER...According to ICH GCP The investigator should be thoroughly familiar with the
appropriate use of the investigational product(s), as described in the:
the duration of treatment for each trial subject - ....ANSWER...Which of the following is not in the list given by ICH GCP for the factors guiding the audit plan and procedures for a trial audit; importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, or the duration of treatment for each trial subject?
Phase I - ....ANSWER...The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers
Who is ultimately responsible for all aspects of the research conducted at a site? - ....ANSWER...Principal investigator
Define GCP - ....ANSWER...An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data
What event resulted in the Nuremburg Cod of 1949 - ....ANSWER...Nazi Medical Experiments
Which ICH Guideline is known as the GCP guideline?
What are the basic ethical principles of the Belmont Report? - ....ANSWER...Beneficence, Respect for persons, Justice
Define CBER, and full title - ....ANSWER...Center for Biologics Evaluation and Research
FDA center that regulates blood, vaccine, gene therapy and tissue
What is the International Conference on Harmonization (ICH) Guidelines? - ....ANSWER...A unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and United States.