ACRP CCRA EXAM LATEST
PREP
Name an element of a feasibility assessment related to analyzing clinical
and ethical characteristics of protocol design and perceived impact of
study objectives on local patients treatment. - ANSWERS-Interest
True or False? Researchers have found that trials failing to reach 60%
minimum projected accrual goal within expected period will always
reach enrollment goals by time of enrollment closure. - ANSWERS-
False
What are elements of a formal feasibility assessment process? -
ANSWERS-- Interest
- Accruability
- Capacity
- Menu diversification
True or False? One of four participants leave a trial before it's
completed. - ANSWERS-True
True or False? Only ~50% of participant who signed consent could
explain how they're randomized during the trial. - ANSWERS-True
END OF
PAGE
1
, ACRP CCRA EXAM LATEST
PREP
True or False? Clinical research sites may recruit subjects for trials by
contacting their own patients, asking outside physicians to refer their
patients, or by advertising trial within community. - ANSWERS-True
True or False? It's important for a clinical research site to have a clinical
trial menu reflective of patient population. A formal feasibility
assessment of all potential trials often satisfies this need. Assessment
includes examining interest, capacity, potential rate of accrual and
diversification - ANSWERS-True
True or False? Sponsors expect sites to be prepared with estimate of
number of subjects they believe they can enroll within specific time
frames, including justification for the amount. This estimate is used by
sponsors to determine which sites to invite to participate in their trials. -
ANSWERS-True
True or False? A well-educated person is always health literate. -
ANSWERS-False
True or False? Typically, when a participant signs consent, it indicates
they clearly understand the information within the consent and details of
trial. - ANSWERS-False
END OF
PAGE
2
, ACRP CCRA EXAM LATEST
PREP
True or False? In the US, it's ethically unacceptable to routinely consider
non-english speaking patients ineligible for trial. - ANSWERS-True
True or False? It's important for research sites to have a plan in place
(including qualified translators) for consent patients with LEP. -
ANSWERS-True
TWhich are operational principles for effective and efficient recruitment
and retention? - ANSWERS-- Support: All enrolled participants receive
adequate support to ensure compliance and retention throughout trial.
- Normalization: Trials are normalized by all staff/providers on an
institutional-wide basis through effective communication with patients
- Trial selection: Trials selected for local implementation will
appropriately meet need of local participants.
Which groups have the lowest participation rates? - ANSWERS-- People
above 65 years old
- People from rural areas
- People from racial/ethnic minority groups
END OF
PAGE
3
, ACRP CCRA EXAM LATEST
PREP
Sponsors consider what criteria when selecting clinical research sites for
their trials - ANSWERS-- Coordinator workload (number of studies per
coordinator)
- IRB/IEC timelines and reporting policies
- Number/type of competing trials ongoing at site
- Investigator expertise in area being researched
Which elements of patient centered care as described? - ANSWERS--
Learning style
- Health literacy
- Emotions
Which are characteristics of health literacy? - ANSWERS-- Capacity to
process and understand basic healthcare information
- Rely on cultural/conceptual knowledge
What's the take home point? Patient approach and offer: A clinical site
makes a decision that each patient who's potentially eligible for trial be
offered a chance to participant. - ANSWERS-Reducing opportunities for
subjective assessment.
END OF
PAGE
4
PREP
Name an element of a feasibility assessment related to analyzing clinical
and ethical characteristics of protocol design and perceived impact of
study objectives on local patients treatment. - ANSWERS-Interest
True or False? Researchers have found that trials failing to reach 60%
minimum projected accrual goal within expected period will always
reach enrollment goals by time of enrollment closure. - ANSWERS-
False
What are elements of a formal feasibility assessment process? -
ANSWERS-- Interest
- Accruability
- Capacity
- Menu diversification
True or False? One of four participants leave a trial before it's
completed. - ANSWERS-True
True or False? Only ~50% of participant who signed consent could
explain how they're randomized during the trial. - ANSWERS-True
END OF
PAGE
1
, ACRP CCRA EXAM LATEST
PREP
True or False? Clinical research sites may recruit subjects for trials by
contacting their own patients, asking outside physicians to refer their
patients, or by advertising trial within community. - ANSWERS-True
True or False? It's important for a clinical research site to have a clinical
trial menu reflective of patient population. A formal feasibility
assessment of all potential trials often satisfies this need. Assessment
includes examining interest, capacity, potential rate of accrual and
diversification - ANSWERS-True
True or False? Sponsors expect sites to be prepared with estimate of
number of subjects they believe they can enroll within specific time
frames, including justification for the amount. This estimate is used by
sponsors to determine which sites to invite to participate in their trials. -
ANSWERS-True
True or False? A well-educated person is always health literate. -
ANSWERS-False
True or False? Typically, when a participant signs consent, it indicates
they clearly understand the information within the consent and details of
trial. - ANSWERS-False
END OF
PAGE
2
, ACRP CCRA EXAM LATEST
PREP
True or False? In the US, it's ethically unacceptable to routinely consider
non-english speaking patients ineligible for trial. - ANSWERS-True
True or False? It's important for research sites to have a plan in place
(including qualified translators) for consent patients with LEP. -
ANSWERS-True
TWhich are operational principles for effective and efficient recruitment
and retention? - ANSWERS-- Support: All enrolled participants receive
adequate support to ensure compliance and retention throughout trial.
- Normalization: Trials are normalized by all staff/providers on an
institutional-wide basis through effective communication with patients
- Trial selection: Trials selected for local implementation will
appropriately meet need of local participants.
Which groups have the lowest participation rates? - ANSWERS-- People
above 65 years old
- People from rural areas
- People from racial/ethnic minority groups
END OF
PAGE
3
, ACRP CCRA EXAM LATEST
PREP
Sponsors consider what criteria when selecting clinical research sites for
their trials - ANSWERS-- Coordinator workload (number of studies per
coordinator)
- IRB/IEC timelines and reporting policies
- Number/type of competing trials ongoing at site
- Investigator expertise in area being researched
Which elements of patient centered care as described? - ANSWERS--
Learning style
- Health literacy
- Emotions
Which are characteristics of health literacy? - ANSWERS-- Capacity to
process and understand basic healthcare information
- Rely on cultural/conceptual knowledge
What's the take home point? Patient approach and offer: A clinical site
makes a decision that each patient who's potentially eligible for trial be
offered a chance to participant. - ANSWERS-Reducing opportunities for
subjective assessment.
END OF
PAGE
4
