ACRP CCRC Exam – Questions With Complete
Solutions
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Terms in this set (114)
1. Pre-study visit
Monitoring visits occur in 2. Site initiation visit
what order? 3. Routine monitoring visit(s)
4. Study close-out visit
What is the first type of Pre-study visit (PSV)
monitoring visit called?
Pre-study visits are also Site selection visit
called:
1. Confirm qualifications & experience of PI
2. Assess adequacy of site (facilities & equipment)
What are the 4 main
3. Assess potential patient population
goals of pre-study visits?
4. Assess training, experience, and availability of site
staff
What is the second type Site initiation visit (SIV)
of monitoring visit
called?
What are the 2 main 1. CRA to thoroughly train site on all study aspects
goals of site initiation B. Confirm if site is ready for activation & able to
visits? begin enrolling subjects
What is the third type of Interim/routine monitoring visit
monitoring visit called?
1. Ensure rights & wellbeing of subjects are
Per GCP, monitoring visits protected
fulfill 2 main objectives: 2. Ensure study data is accurate, complete, and
verifiable from source documentation
,Routine monitoring 1. Protocol
ensures studies are 2. GCP
conducted in compliance 3. Regulatory requirements
with (3):
What is the fourth type of Close-out visit
monitoring visit called?
The goal of a close-out To ensure site is ready for closure
visit is:
1. Perform final reconciliation of study documents &
The 2 main objectives of study supplies
close-out visits are: 2. Monitor ensures PI is aware of all regulatory
obligations after closure
The following activities Pre-study visit
are associated which
type of monitoring visit?
1. Review of regulatory
documentation
2. Evaluation of site
facilities, equipment, and
supplied
3. Assess training &
competence of PI, study
coordinators, and other
study staff
4. Discuss site plans for
patient recruitment &
enrollment (including
identification of
participants & screening)
5. Review site data
management processes &
systems, to assess
adequacy
1. After the site has been selected & approved by
Site initiation visits occur
the sponsor
after which 2 processes
2. After the site has completed all necessary
have been completed:
regulatory & ethical approvals
, The following activities Site initiation visit
are associated with which
type of monitoring visit?
1. Review of study
protocol
2. Ensure facilities &
equipment are suitable to
conduct study/meet
regulatory requirements
3. Staff training on
protocol, procedures,
data management, and
requirements for conduct
4. Review of study forms
& tools, such as CRF
5. Review of informed
consent process
(including ICF & patient
education materials)
6. Activation of data
management systems
(such as EDC) to ensure
readiness to collect,
store, and report study
data
7. Begin recruitment &
enrollment
Solutions
Save
Terms in this set (114)
1. Pre-study visit
Monitoring visits occur in 2. Site initiation visit
what order? 3. Routine monitoring visit(s)
4. Study close-out visit
What is the first type of Pre-study visit (PSV)
monitoring visit called?
Pre-study visits are also Site selection visit
called:
1. Confirm qualifications & experience of PI
2. Assess adequacy of site (facilities & equipment)
What are the 4 main
3. Assess potential patient population
goals of pre-study visits?
4. Assess training, experience, and availability of site
staff
What is the second type Site initiation visit (SIV)
of monitoring visit
called?
What are the 2 main 1. CRA to thoroughly train site on all study aspects
goals of site initiation B. Confirm if site is ready for activation & able to
visits? begin enrolling subjects
What is the third type of Interim/routine monitoring visit
monitoring visit called?
1. Ensure rights & wellbeing of subjects are
Per GCP, monitoring visits protected
fulfill 2 main objectives: 2. Ensure study data is accurate, complete, and
verifiable from source documentation
,Routine monitoring 1. Protocol
ensures studies are 2. GCP
conducted in compliance 3. Regulatory requirements
with (3):
What is the fourth type of Close-out visit
monitoring visit called?
The goal of a close-out To ensure site is ready for closure
visit is:
1. Perform final reconciliation of study documents &
The 2 main objectives of study supplies
close-out visits are: 2. Monitor ensures PI is aware of all regulatory
obligations after closure
The following activities Pre-study visit
are associated which
type of monitoring visit?
1. Review of regulatory
documentation
2. Evaluation of site
facilities, equipment, and
supplied
3. Assess training &
competence of PI, study
coordinators, and other
study staff
4. Discuss site plans for
patient recruitment &
enrollment (including
identification of
participants & screening)
5. Review site data
management processes &
systems, to assess
adequacy
1. After the site has been selected & approved by
Site initiation visits occur
the sponsor
after which 2 processes
2. After the site has completed all necessary
have been completed:
regulatory & ethical approvals
, The following activities Site initiation visit
are associated with which
type of monitoring visit?
1. Review of study
protocol
2. Ensure facilities &
equipment are suitable to
conduct study/meet
regulatory requirements
3. Staff training on
protocol, procedures,
data management, and
requirements for conduct
4. Review of study forms
& tools, such as CRF
5. Review of informed
consent process
(including ICF & patient
education materials)
6. Activation of data
management systems
(such as EDC) to ensure
readiness to collect,
store, and report study
data
7. Begin recruitment &
enrollment
