ACRP CCRC Exam Questions and Answers Grade A+
Monitoring visits occur in what order? - Answer-1. Pre-study visit
2. Site initiation visit
3. Routine monitoring visit(s)
4. Study close-out visit
What is the first type of monitoring visit called? - Answer-Pre-study visit (PSV)
Pre-study visits are also called: - Answer-Site selection visit
What are the 4 main goals of pre-study visits? - Answer-1. Confirm qualifications & experience
of PI
2. Assess adequacy of site (facilities & equipment)
3. Assess potential patient population
4. Assess training, experience, and availability of site staff
What is the second type of monitoring visit called? - Answer-Site initiation visit (SIV)
What are the 2 main goals of site initiation visits? - Answer-1. CRA to thoroughly train site on all
study aspects
B. Confirm if site is ready for activation & able to begin enrolling subjects
What is the third type of monitoring visit called? - Answer-Interim/routine monitoring visit
Per GCP, monitoring visits fulfill 2 main objectives: - Answer-1. Ensure rights & wellbeing of
subjects are protected
2. Ensure study data is accurate, complete, and verifiable from source documentation
Routine monitoring ensures studies are conducted in compliance with (3): - Answer-1. Protocol
2. GCP
3. Regulatory requirements
What is the fourth type of monitoring visit called? - Answer-Close-out visit
The goal of a close-out visit is: - Answer-To ensure site is ready for closure
The 2 main objectives of close-out visits are: - Answer-1. Perform final reconciliation of study
documents & study supplies
, 2. Monitor ensures PI is aware of all regulatory obligations after closure
The following activities 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 - Answer-Pre-study
visit
Site initiation visits occur after which 2 processes have been completed: - Answer-1. After the
site has been selected & approved by the sponsor
2. After the site has completed all necessary regulatory & ethical approvals
The following activities 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 - Answer-Site initiation visit
The following activities are associated with which type of monitoring visit?
1. Review of study conduct, including enrollment of subjects, administration of study
interventions, collection & management of study data, and management of adverse events
2. Review of study documentation, such as ICF, CRF, subject medical records & lab data
3. Review of site compliance with protocol, GCP & regulatory requirements; provide feedback &
guidance on identified issues
4. Follow up on previous monitoring findings
Monitoring visits occur in what order? - Answer-1. Pre-study visit
2. Site initiation visit
3. Routine monitoring visit(s)
4. Study close-out visit
What is the first type of monitoring visit called? - Answer-Pre-study visit (PSV)
Pre-study visits are also called: - Answer-Site selection visit
What are the 4 main goals of pre-study visits? - Answer-1. Confirm qualifications & experience
of PI
2. Assess adequacy of site (facilities & equipment)
3. Assess potential patient population
4. Assess training, experience, and availability of site staff
What is the second type of monitoring visit called? - Answer-Site initiation visit (SIV)
What are the 2 main goals of site initiation visits? - Answer-1. CRA to thoroughly train site on all
study aspects
B. Confirm if site is ready for activation & able to begin enrolling subjects
What is the third type of monitoring visit called? - Answer-Interim/routine monitoring visit
Per GCP, monitoring visits fulfill 2 main objectives: - Answer-1. Ensure rights & wellbeing of
subjects are protected
2. Ensure study data is accurate, complete, and verifiable from source documentation
Routine monitoring ensures studies are conducted in compliance with (3): - Answer-1. Protocol
2. GCP
3. Regulatory requirements
What is the fourth type of monitoring visit called? - Answer-Close-out visit
The goal of a close-out visit is: - Answer-To ensure site is ready for closure
The 2 main objectives of close-out visits are: - Answer-1. Perform final reconciliation of study
documents & study supplies
, 2. Monitor ensures PI is aware of all regulatory obligations after closure
The following activities 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 - Answer-Pre-study
visit
Site initiation visits occur after which 2 processes have been completed: - Answer-1. After the
site has been selected & approved by the sponsor
2. After the site has completed all necessary regulatory & ethical approvals
The following activities 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 - Answer-Site initiation visit
The following activities are associated with which type of monitoring visit?
1. Review of study conduct, including enrollment of subjects, administration of study
interventions, collection & management of study data, and management of adverse events
2. Review of study documentation, such as ICF, CRF, subject medical records & lab data
3. Review of site compliance with protocol, GCP & regulatory requirements; provide feedback &
guidance on identified issues
4. Follow up on previous monitoring findings
