Exam (elaborations)
ACRP CP Exam 2024!!
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Name: Score:542 Multiple choice questions
Term 1 of 542
Which of the following most accurately describes good mentoring practice?
Encouraging trainees to receive mentoring from a collection of individuals
Discouraging trainees from seeking guidance
Limiting trainees to one mentor for life
Ignoring the need for mentorship
Term 2 of 542
45 CFR 46
Also known as the Common Rule, this legislation established the role of institutional review
boards (IRBs) for research on human rights.
the subjects are split into at least 2 groups: those receiving the experimental agent and
those receiving a standard treatment for the condition, no treatment, or a placebo. If
subjects are assigned randomly into these groups, the study is a randomized controlled
trial.
The medical center to replace the use of paper records with electronic records for its
research
Informed Consent
Definition 3 of 542
researchers or sponsors from one country conducting or funding work in another
International research collaboration
Multidisciplinary collaboration
Corresponding author
Study feasibility
,Definition 4 of 542
1) The rights and well-bring of human subjects are protected
2) The reported trial data is accurate, complete and verifiable from source documents
3) The conduct of the trial is in compliance with the currently approved protocol/amendment(s),
with GCP, and with applicable regulatory requirements
o Sponsor-investigators must develop monitoring plans based on the human subject protection
and data integrity risks of the clinical trial.
PHS-funded investigators must disclose SFIs related to their institutional responsibilities
and reimbursed or sponsored travel to their institutions. That is, the institution must review
the disclosed information and determine whether the interests:
One of the responsibilities for sponsors of clinical investigations involving new drugs and
medical devices under 21 CFR 312.56 AND 812.46 and ICH E6 is to monitor the progress of a
clinical investigation. According to ICH E6, the purpose of trial monitoring are to verify that:
The institution must update the funding agency on the status of the FCOI and any changes
to the management plan annually. In accordance with the regulations, an institution's
management plan must describe the:
The informed consent process includes:
Definition 5 of 542
Pertain to the use of the available tools and processes for managing information throughout a
research project's lifecycle and after the project concludes. This is sometimes called data lifecycle
management. Its main goals are to ensure data confidentiality, integrity, and availability for as long
as the data exists. Achieving such goals requires a combination of measures, which balance
prevention, detection, and response to problems.
Economic Conditions
Technological Development
Global Issues
Technological Issues
,Term 6 of 542
21 CFR 52
a. To provide a potential subject with appropriate information in an appropriate manner and
allow that person to make an informed decision about participation in research.
FDA COI regulations requiring the sponsor of a clinical trial to provide certain financial
interest information about the clinical trial investigators when submitting a marketing
application for drug, biological product, or device.
covers the protection of human research subjects in federally funded research projects.
45 CFR 46 was revised in 2017 and differs slightly from the FDA regulations for the
protection of human subjects. It is important to know the differences and when each
regulation applies in order to remain in compliance
1) Significant risk (SR) device investigations: all significant risk device studies must be
performed under an IDE, unless exempt under 21 CFR 812.2
3) Nonsignificant Risk (NSR) Device investigations: do not need to be performed under an
IDE. IRB approval, informed consent, and appropriate monitoring of the study are required
for most NSR studies
Term 7 of 542
If a researcher does not disclose an SFI in a timely manner, or if for any reason the institution did
not previously review it, the institution must, within ____ days from that point, determine whether
the SFI relates to PHS-funded research and if it is an FCOI. If it is a FCOI, the institution must
implement, at least on an interm basis, a management plan
GCP
protocol
translated
60
, Term 8 of 542
Types of on-site monitoring visits:
· when identified before market approval means any noxious and unintended response to a
medicinal product related to any dose; causal relationship between the medicinal product
and an ADR is at least a reasonable possibility.
ADRs identified after market approval are defined as any noxious and unintended response
to a drug that occurs at doses normally used in individuals to prevent, diagnose, or treat
disease or to modify physiological function
covers the protection of human research subjects in federally funded research projects.
45 CFR 46 was revised in 2017 and differs slightly from the FDA regulations for the
protection of human subjects. It is important to know the differences and when each
regulation applies in order to remain in compliance
Types of on-site monitoring visits:
o The pre-study site visit: Used to determine qualified candidates for running the study
The three main objectives of pre-study visits are to:
1) Assess an investigator's interest in conducting the study
2) Evaluate the facility and the staff, determining if they have the capacity to successfully
conduct the trial
3) Determine whether they will be able to meet recruitment goals
o Site initiation visit: the primary objective is train the investigator and study team to
conduct the trial according to protocol requirements
o Periodic site visits
o Study closeout visit: the objective is to ensure that the site has fulfilled all of its
responsibilities for the study
1) Selecting clinical researchers qualified by training and experience
2) Informing and qualifying researchers by obtaining their commitment to supervise the
study, follow the research plan, and obtain consent
3) Monitoring the study's conduct by auditing documentation and conducting site visits
4) Completing regulatory filing related to the IND or IDE, adverse events, amendments or
revisions, progress reports, withdrawal of IRB approval, and final reports
5) Controlling the distribution, tracking, ad dispensation of the regulated products
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