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ACRP CCRC ACTUAL TEST 2024 WITH REAL QUESTIONS AND WELL VERIFIED ANSWERS || ALREADY GRADED + | GUARANTEED PASS | LATEST VERSION 2024/2025!!! $23.49   Add to cart

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ACRP CCRC ACTUAL TEST 2024 WITH REAL QUESTIONS AND WELL VERIFIED ANSWERS || ALREADY GRADED + | GUARANTEED PASS | LATEST VERSION 2024/2025!!!

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ACRP CCRC ACTUAL TEST 2024 WITH REAL QUESTIONS AND WELL VERIFIED ANSWERS || ALREADY GRADED + | GUARANTEED PASS | LATEST VERSION 2024/2025!!! Documents that may be inspected to show the sponsors oversight of trial may include: - ANSWER-- Documents that describe transfer of obli...

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  • September 5, 2024
  • 43
  • 2024/2025
  • Exam (elaborations)
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  • acrp ccrc actual test
  • ACRP CCRC ACTUAL
  • ACRP CCRC ACTUAL
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ACRP CCRC ACTUAL TEST 2024 WITH REAL
QUESTIONS AND WELL VERIFIED ANSWERS ||
ALREADY GRADED + | GUARANTEED PASS |
LATEST VERSION 2024/2025!!!




Documents that may be inspected to show the sponsors oversight of trial may
include: - ANSWER-- Documents that describe transfer of obligations
- Investigator/site qualifications/selection process and training
- Monitoring plans, reports and corrective actions through the monitoring process
According to ICH E9, IDMCs should provide what? - ANSWER-- Intervals assess
the safety of clinical trial
- Recommend to sponsor whether to continue, modify, or stop trial
What does NAI stand for? - ANSWER-No action indicated


What does VAI stands for? - ANSWER-Voluntary action indicated


What does OAI stand for? - ANSWER-Official action indicated


A report prepared by marketing-authorization holder describing the worldwide
safety experience with medicine at defined time after authorization is called? -
ANSWER-Periodic Safety Update Report (PSUR)

,Potential reasons for an unannounced clinical investigator inspection can include
what? - ANSWER-- Receipt of complaint
- On termination of clinical site
- In response to sponsor or IRB/IEC inspections


Important immediate inspection preparation strategies include: - ANSWER--
Inform personnel
- Secure facility resources
- Organize study related documents
- Ensure access to original data


Directed/for-cause inspections may focus on? - ANSWER-The particular reason
that prompted the inspection


What is the major focus area for routine inspections for a clinical investigator? -
ANSWER-- Data reviews
- ICF process and documentation


What is the major focus area for a sponsor/CRO GCP inspection related to trial? -
ANSWER-- Vendor selection and management
- Data management (e.g. review of data management plan)


Common inspection management strategies include? - ANSWER-- Scope of
inspection
- Understand inspection timeframes
-Copy of personnel records

,What type of risk-based inspection involves the selection of a number of clinical
trials for the inspection sample? - ANSWER-Routine National Systems Inspections


True or False? Globalization of clinical research is a major factor that's led to
development of a common and accepted framework and sharing of inspection
observations in different regions. - ANSWER-True


The FRD CDER published information about inspection site selection tools that
takes into account what three levels of risk attributes? - ANSWER-Application
level, study level, clinical site level


Factors that influence GCP inspection selection process include? - ANSWER--
The number of UK patients and nature of subjects
- Outcome of previous GCP inspections
- Organization with no inspection history


True or False? Concerns about accuracy of submitted data can include an unusual
recruitment pattern. - ANSWER-True


True or False? For the EMA, inspections are conducted by the EMA inspectorate
of the EU. - ANSWER-False


True or False? Comprehensive data management plans can help ensure the
recording of accurate and complete data. - ANSWER-True


True or False? Regulatory investigators must have rights/privileges granted for
electronic record systems. - ANSWER-True

, Current coordinator is asked a question about the enrollment source completed by
prior coordinator during regulatory inspection. What should her response be if she
knows the correct answer? - ANSWER-Decline answer as she has no first-hand
knowledge of the creation of source document




Which are for full-analysis sample set? - ANSWER-- Includes all randomized
subjects
- Complete follow-up of all randomized subjects for study outcomes if necessary
- Most likely to mirror normal day to day practice


Which are for a per-protocol sample set? - ANSWER-- Completion of pre-
specified minimal exposure to treatment is necessary
- Availability of measurements of primary variable is necessary
- No major protocol violations nor violation of entry criteria


Investigator continues to randomize patient until patient is grouped with
investigators desired product. Is this ethical? - ANSWER-No


Data manager suspects fraud and immediately calls investigator stating fraud was
committed. Was this the best course of action? - ANSWER-No


What must or may the physician do with regard to unproven intervention?
(Declaration of Helsinki) - ANSWER-May consider an unproved intervention
What are expected or possible consequences of over-estimation of recruitment
potential? - ANSWER-- The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget

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