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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
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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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Course
ACRP CCRC ACTUAL
Institution
ACRP CCRC ACTUAL
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...
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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