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ACRP CCRA FINAL EXAM LATEST 2025/2026 ACTUAL EXAM WITH
COMPLETE QUESTIONS AND CORRECT DETAILED ANSWERS (100%
VERIFIED ANSWERS) |ALREADY GRADED A+| ||PROFESSOR
VERIFIED|| ||BRANDNEW!!!||
How soon before the FDA, OMB expiration date, must the form
1572 be revised and submitted? - ANSWER-This date doesn't
apply to the resubmission of form and should be ignored.
If there are co-investigators working on a clinical trial, where
should they be listed on 1572? - ANSWER-Submit separate 1572
for each investigator.
Who's the least likely to be included in section 6 on 1572? -
ANSWER-On-site pharmacist who's only dispensing IP.
What's considered part of documentation of delgation? -
ANSWER-- Identification of dates of involvement in clinical trials
- Proof of training received that qualifies individual to perform a
delegated task
- Description of the delegated tasks
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What are the purposes of the 1572 form? - ANSWER--Identify
facilities involved in conducting the clinical trial project
- Commitment by investigator for appropriate conduct of the
clinical trial
- Name and address of where the investigation will be held
True and False? If a clinical trial required home visits, the subjects
address should be listed on 1572. - ANSWER-False
True or False? If a resident is on rotation, and assessed an AE,
it's okay if they're NOT listed on 1572. - ANSWER-True
True or False? The 1572 is considered a legally binding contract
between the PI and FDA. - ANSWER-False
Clinical trials assessing a medicinal products safety may fall
which phases? - ANSWER-Phase I, II, III, IV
In which trial phases would the following trial design most likely be
found? An international double-blind randomized trial comparing
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the efficacy of two doses of trial drug with a commonly used
competition in 50 sites recruitment of 10-30 subjects each. -
ANSWER-Phase III, IV
The drug 'Enhance' has been approved for marketing in wound
healing in adults. When it's on the market, the plan is to explore
using it in children in the future. Which actions should be taken? -
ANSWER-- A development program for use in children should be
written
- Experience with use in children so far should be collected and
used in the development plan
- Conduct pharmacodynamic/pharmacokinetic studies in children
if theres no relevant information available from similar compounds
What should be contained in study design? - ANSWER--
Appropriate comparators
- Adequate numbers of subjects
- Clear endpoints
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You're a CRA looking for a site to conduct a phase II trial. What
should you be looking for to ensure the site is able to conduct the
trial successfully? - ANSWER-- Sufficient resources to ensure
patient safety
- Sufficient resources (staff, materials, financial) to conduct the
required interventions as per protocol
- Ability to collect data on therapeutic efficacy, dosage, and other
trial-specific goals
A site struggles with the conduct of a phase III trial due to lack of
site staff to be able to conduct all visits and collect required data
as identified in the protocol. Upon completion, the investigator
tells the CRA and site staff during a follow-up meeting that she no
longer wants to conduct trials because of the resource challenges
they faced. What would you recommend the investigator do? -
ANSWER-Evaluate available resources (staff, time, patient
population, financial) and conduct trials in phase for which the site
has resources.
What's the difference between phase III and IV trial? - ANSWER--
Phase IV usually requires more subjects and data collection than
Phase III
ACRP CCRA FINAL EXAM LATEST 2025/2026 ACTUAL EXAM WITH
COMPLETE QUESTIONS AND CORRECT DETAILED ANSWERS (100%
VERIFIED ANSWERS) |ALREADY GRADED A+| ||PROFESSOR
VERIFIED|| ||BRANDNEW!!!||
How soon before the FDA, OMB expiration date, must the form
1572 be revised and submitted? - ANSWER-This date doesn't
apply to the resubmission of form and should be ignored.
If there are co-investigators working on a clinical trial, where
should they be listed on 1572? - ANSWER-Submit separate 1572
for each investigator.
Who's the least likely to be included in section 6 on 1572? -
ANSWER-On-site pharmacist who's only dispensing IP.
What's considered part of documentation of delgation? -
ANSWER-- Identification of dates of involvement in clinical trials
- Proof of training received that qualifies individual to perform a
delegated task
- Description of the delegated tasks
,2|Page
What are the purposes of the 1572 form? - ANSWER--Identify
facilities involved in conducting the clinical trial project
- Commitment by investigator for appropriate conduct of the
clinical trial
- Name and address of where the investigation will be held
True and False? If a clinical trial required home visits, the subjects
address should be listed on 1572. - ANSWER-False
True or False? If a resident is on rotation, and assessed an AE,
it's okay if they're NOT listed on 1572. - ANSWER-True
True or False? The 1572 is considered a legally binding contract
between the PI and FDA. - ANSWER-False
Clinical trials assessing a medicinal products safety may fall
which phases? - ANSWER-Phase I, II, III, IV
In which trial phases would the following trial design most likely be
found? An international double-blind randomized trial comparing
,3|Page
the efficacy of two doses of trial drug with a commonly used
competition in 50 sites recruitment of 10-30 subjects each. -
ANSWER-Phase III, IV
The drug 'Enhance' has been approved for marketing in wound
healing in adults. When it's on the market, the plan is to explore
using it in children in the future. Which actions should be taken? -
ANSWER-- A development program for use in children should be
written
- Experience with use in children so far should be collected and
used in the development plan
- Conduct pharmacodynamic/pharmacokinetic studies in children
if theres no relevant information available from similar compounds
What should be contained in study design? - ANSWER--
Appropriate comparators
- Adequate numbers of subjects
- Clear endpoints
, 4|Page
You're a CRA looking for a site to conduct a phase II trial. What
should you be looking for to ensure the site is able to conduct the
trial successfully? - ANSWER-- Sufficient resources to ensure
patient safety
- Sufficient resources (staff, materials, financial) to conduct the
required interventions as per protocol
- Ability to collect data on therapeutic efficacy, dosage, and other
trial-specific goals
A site struggles with the conduct of a phase III trial due to lack of
site staff to be able to conduct all visits and collect required data
as identified in the protocol. Upon completion, the investigator
tells the CRA and site staff during a follow-up meeting that she no
longer wants to conduct trials because of the resource challenges
they faced. What would you recommend the investigator do? -
ANSWER-Evaluate available resources (staff, time, patient
population, financial) and conduct trials in phase for which the site
has resources.
What's the difference between phase III and IV trial? - ANSWER--
Phase IV usually requires more subjects and data collection than
Phase III
