ACRP CCRA COMPREHENSIVE ANSWERS AND
QUESTIONS SET A+
✔✔True or False? RBM will have no impact on site. - ✔✔False
✔✔True or False? An example of a risk indicator would be an out of range laboratory
value related to IC/EC on a subject that was just randomized. - ✔✔True
✔✔True or False? RBM embraces quality improvement processes? - ✔✔True
✔✔True or False? A key component of RBM is building quality into protocol design in
order to enable more focused and efficient monitoring. - ✔✔True
✔✔True or False? Risk-based SDV makes more efficient use of monitoring resources
by focusing on data that impacts patient safety and the integrity of the clinical trial data.
- ✔✔True
✔✔The clinical trials transformation initiative (CTTI) recommends focus on what? -
✔✔Quality by design.
✔✔True or False? RBM focuses on study-specific parameter to determine an
appropriate blend of monitoring activities. - ✔✔True
✔✔True or False? RBM is a FDA based concept that doesn't have any accountability to
international studies. - ✔✔False
✔✔What are three key areas of focus in RBM? - ✔✔- Patient safety
- Accurate representation of key data
- Protocol compliance
✔✔True or False? RBM deploys available monitoring resources without regard for a
trials specific identified risks. - ✔✔False
,✔✔What should be considered part of a proactive approach for a sponsor? - ✔✔-
Identification of risk and strategies for mitigation
- Feasibility process to identify qualified sites
- Training a management plan to ensure sites are equipped to work on study
✔✔What should be considered part of a proactive approach for a site? - ✔✔- Ensure
that the study population matches the site population
- Verification that adequate resources are available to conduct the trial
- Ensure protocol requirements are consistent with standard of care
✔✔What are three key elements included as part of SOP development? - ✔✔- Develop
a template
- Designate categories
- Determine a number system
✔✔Whats an example of quality assurance at a site? - ✔✔Independent audits
✔✔What's the purpose and preferred order of training? - ✔✔Understanding, ownership,
and application.-
✔✔What three assumptions are included in the six knowles principles for adult
learners? - ✔✔- Practical
- Relevancy oriented
- Goal oriented
✔✔True or False? A retroactive approach is the best approach to ensure subject safety.
- ✔✔False
✔✔What's the primary purpose of SOPs? - ✔✔- To ensure consistency through
standardization
- To prevent individuals from conducting procedures differently than their colleagues
✔✔As a foundation for quality control the individuals that implement and follow the
systems much have which of the following characteristics? - ✔✔- Solid understanding of
the processes in place
- Rationale behind why each system is required
- Rationale behind why each SOP is required
✔✔Protocol adherence is derived from what? - ✔✔Good training techniques
✔✔The concept of pouring the pieces out of the box, trying to put the objects together
as quickly as possible, then rebuilding it later is an example of what type of approach? -
✔✔Retroactive approach
, ✔✔What are three techniques used for process improvement? - ✔✔- Correction and
prevention implementation
- Identify plans for process management
- Conducting a RCA to identify cause of error(s)
✔✔What's an example of controlling processes? - ✔✔Identifying a plan for ongoing
management, identify key leaders, and required skills.
✔✔What are three applications of adult learning? - ✔✔- Problem based learning (PBL)
- Clinical problem solving
- Problems require different expertise
✔✔What is a tool to identify gap in performance? - ✔✔Conducting a RCA
✔✔True or False? In the US, device trials are to be conducted under CFR part 812. -
✔✔True
✔✔Which countries adhere to ICH GCP guideline to facilitate the mutual acceptance of
clinical data? - ✔✔Japan, Canada, Switzerland, US, EU
✔✔What is a true statement regarding FDA guidance for industry investigator
responsibilities? - ✔✔FDAs guidance documents do not establish legally enforceable
responsibilities. Instead, guidances describe the agency's current thinking on the topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are sited.
✔✔What are expectations in relation to the qualifications of an investigator? - ✔✔- Be
qualified by education, training, and experience to assume responsibility for the proper
conduct of the trial.
- Be thoroughly familiar with appropriate use of IP
- Permit for monitoring and auditing by the sponsor and inspection by the appropriate
regulatory authorities
✔✔True or False? If the investigator is a non-physician, the investor should make
adequate provision for an necessary medical care. - ✔✔True
✔✔What are three true statements with respect to protecting the rights, safety, and
welfare of study subjects? - ✔✔- Providing subjects with method of communication with
the investigator or qualified designee for questions or concerns
- Adhering to the protocol so that study subjects aren't exposed to unreasonable risk
- Providing reasonable access to needed medical care
✔✔True or False? Protecting the rights, safety, and well-being of clinical trial subjects is
the most important element of investigator responsibility. - ✔✔True
QUESTIONS SET A+
✔✔True or False? RBM will have no impact on site. - ✔✔False
✔✔True or False? An example of a risk indicator would be an out of range laboratory
value related to IC/EC on a subject that was just randomized. - ✔✔True
✔✔True or False? RBM embraces quality improvement processes? - ✔✔True
✔✔True or False? A key component of RBM is building quality into protocol design in
order to enable more focused and efficient monitoring. - ✔✔True
✔✔True or False? Risk-based SDV makes more efficient use of monitoring resources
by focusing on data that impacts patient safety and the integrity of the clinical trial data.
- ✔✔True
✔✔The clinical trials transformation initiative (CTTI) recommends focus on what? -
✔✔Quality by design.
✔✔True or False? RBM focuses on study-specific parameter to determine an
appropriate blend of monitoring activities. - ✔✔True
✔✔True or False? RBM is a FDA based concept that doesn't have any accountability to
international studies. - ✔✔False
✔✔What are three key areas of focus in RBM? - ✔✔- Patient safety
- Accurate representation of key data
- Protocol compliance
✔✔True or False? RBM deploys available monitoring resources without regard for a
trials specific identified risks. - ✔✔False
,✔✔What should be considered part of a proactive approach for a sponsor? - ✔✔-
Identification of risk and strategies for mitigation
- Feasibility process to identify qualified sites
- Training a management plan to ensure sites are equipped to work on study
✔✔What should be considered part of a proactive approach for a site? - ✔✔- Ensure
that the study population matches the site population
- Verification that adequate resources are available to conduct the trial
- Ensure protocol requirements are consistent with standard of care
✔✔What are three key elements included as part of SOP development? - ✔✔- Develop
a template
- Designate categories
- Determine a number system
✔✔Whats an example of quality assurance at a site? - ✔✔Independent audits
✔✔What's the purpose and preferred order of training? - ✔✔Understanding, ownership,
and application.-
✔✔What three assumptions are included in the six knowles principles for adult
learners? - ✔✔- Practical
- Relevancy oriented
- Goal oriented
✔✔True or False? A retroactive approach is the best approach to ensure subject safety.
- ✔✔False
✔✔What's the primary purpose of SOPs? - ✔✔- To ensure consistency through
standardization
- To prevent individuals from conducting procedures differently than their colleagues
✔✔As a foundation for quality control the individuals that implement and follow the
systems much have which of the following characteristics? - ✔✔- Solid understanding of
the processes in place
- Rationale behind why each system is required
- Rationale behind why each SOP is required
✔✔Protocol adherence is derived from what? - ✔✔Good training techniques
✔✔The concept of pouring the pieces out of the box, trying to put the objects together
as quickly as possible, then rebuilding it later is an example of what type of approach? -
✔✔Retroactive approach
, ✔✔What are three techniques used for process improvement? - ✔✔- Correction and
prevention implementation
- Identify plans for process management
- Conducting a RCA to identify cause of error(s)
✔✔What's an example of controlling processes? - ✔✔Identifying a plan for ongoing
management, identify key leaders, and required skills.
✔✔What are three applications of adult learning? - ✔✔- Problem based learning (PBL)
- Clinical problem solving
- Problems require different expertise
✔✔What is a tool to identify gap in performance? - ✔✔Conducting a RCA
✔✔True or False? In the US, device trials are to be conducted under CFR part 812. -
✔✔True
✔✔Which countries adhere to ICH GCP guideline to facilitate the mutual acceptance of
clinical data? - ✔✔Japan, Canada, Switzerland, US, EU
✔✔What is a true statement regarding FDA guidance for industry investigator
responsibilities? - ✔✔FDAs guidance documents do not establish legally enforceable
responsibilities. Instead, guidances describe the agency's current thinking on the topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are sited.
✔✔What are expectations in relation to the qualifications of an investigator? - ✔✔- Be
qualified by education, training, and experience to assume responsibility for the proper
conduct of the trial.
- Be thoroughly familiar with appropriate use of IP
- Permit for monitoring and auditing by the sponsor and inspection by the appropriate
regulatory authorities
✔✔True or False? If the investigator is a non-physician, the investor should make
adequate provision for an necessary medical care. - ✔✔True
✔✔What are three true statements with respect to protecting the rights, safety, and
welfare of study subjects? - ✔✔- Providing subjects with method of communication with
the investigator or qualified designee for questions or concerns
- Adhering to the protocol so that study subjects aren't exposed to unreasonable risk
- Providing reasonable access to needed medical care
✔✔True or False? Protecting the rights, safety, and well-being of clinical trial subjects is
the most important element of investigator responsibility. - ✔✔True
