ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
Double Dummy - CORRECT ANSWERS both groups of patients in a placebo controlled
study take
Who is ultimately responsible for staff training? - CORRECT ANSWERS PI
Can PI share study enrollment w/ PCP overseeing care? - CORRECT ANSWERS yes, if
subject agrees/consents
Who gives IB to investigator? - CORRECT ANSWERS sponsor
Who gives IB to IRB? - CORRECT ANSWERS investigator
Does the PI need to notify sponsor of administrative changes to protocol, ICF, etc - CORRECT
ANSWERS No
Who has responsibility for investigational product accountability? - CORRECT ANSWERS
PI/Site
If unblinding occurs who reports & to whom? - CORRECT ANSWERS PI to sponsor only
LARs may sign for a subject if what conditions exist? - CORRECT ANSWERS -non-
therapeutic studies only
-low risk to subject
- cannot be conducted otherwise
-IRB approves it
,ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
-trial is not illegal by law
Who reports change of risks to subjects & to whom? - CORRECT ANSWERS PI to
sponsor & IRB & site
Who reports AEs & SAEs / to whom & in what order? - CORRECT ANSWERS PI to 1.
sponsor and then 2. IRB
Premature trial termination should be reported using what schematic? - CORRECT
ANSWERS Termination Vortex
Termination Vortex - CORRECT ANSWERS PI -----> Subjects
Below is a triangle of communication - two way streets with all parties
PI <------> Sponsor
PI <-----> IRB
IRB <------>Sponsor
Who creates SOPs - CORRECT ANSWERS sponsor
Who initiates and secures the agreement? - CORRECT ANSWERS sponsor
A CRO has been enlisted to oversee a study, who is primarily responsible for integrity of trial
data? - CORRECT ANSWERS sponsor
,ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
Expedited reporting of AEs is necessary when what 2 things exist? - CORRECT ANSWERS
Serious & unexpected
Who appoints a monitor? - CORRECT ANSWERS sponsor
Who acts as main point of contact b/w the PI & sponsor? - CORRECT ANSWERS
monitor
Monitor should conduct monitoring visits according to what, created by whom? - CORRECT
ANSWERS SOPs / monitoring specifics, by the sponsor
Audits differ from monitoring visits because - CORRECT ANSWERS monitoring visits
assess safety of subjects and day to day data collection & source documents. audits look for
compliance with approved protocols
Monitors & Auditors differ in what major way? - CORRECT ANSWERS monitors are
supplied by sponsor as part of sponsor team. Auditors are independent.
An untoward event in a patient or clinical investigational subject administered a pharmaceutical
product which does not necessarily have a causal relationship is what? - CORRECT
ANSWERS Adverse event
an adverse drug reaction requires what level of causality? - CORRECT ANSWERS
reasonable possibility
ADRs should be expeditiously reported when what two factors are present? - CORRECT
ANSWERS serious/unexpected
, ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
fatal / life threatening ADRs should be submitted in what time frame? - CORRECT
ANSWERS no later than 7 days, but ASAP
Other serious, but non-fatal / life-threatening ADRs should be reported in what time frame? -
CORRECT ANSWERS ASAP, no more than 15 days
A protocol requires that subjects in a hypertension trial have two consecutive sitting diastolic
blood pressure readings performed and the average of the two recorded on the CRF. The CRA
discovers that only one blood pressure reading is recorded in the source documents, which is
the same as the reading recorded in the CRF for the 10 enrolled subjects. Which of the
following would the CRC expect the CRA to do FIRST?
A. Contac the sponsor's medical monitor to report that the investigator is noncompliant with
the protocol.
B. Notify the data management department that the CRF entries are incorrect and may need to
be queried.
C. Ask the investigator if the blood pressure procedure outlined in the protocol is being
followed.
D. Contact the sponsor's medical monitor to discuss closing the site due to 10 protocol
violations. - CORRECT ANSWERS C
Reason: It is reasonable for the CRC to anticipate the CRA asking the investigator for an
explanation regarding study procedure in this case. However, as it appears that the site is both
noncompliant with the protocol (only one blood pressure check) and documenting the same
result in several patient charts, falsification of data would be a legitimate concern of the CRA,
who would document the finding in a routine monitoring report and closely watch it further as
the study progresses. Following such a discussion with the investigator, the medical monitor
may be notified so that the situation could be examined accordingly.
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
Double Dummy - CORRECT ANSWERS both groups of patients in a placebo controlled
study take
Who is ultimately responsible for staff training? - CORRECT ANSWERS PI
Can PI share study enrollment w/ PCP overseeing care? - CORRECT ANSWERS yes, if
subject agrees/consents
Who gives IB to investigator? - CORRECT ANSWERS sponsor
Who gives IB to IRB? - CORRECT ANSWERS investigator
Does the PI need to notify sponsor of administrative changes to protocol, ICF, etc - CORRECT
ANSWERS No
Who has responsibility for investigational product accountability? - CORRECT ANSWERS
PI/Site
If unblinding occurs who reports & to whom? - CORRECT ANSWERS PI to sponsor only
LARs may sign for a subject if what conditions exist? - CORRECT ANSWERS -non-
therapeutic studies only
-low risk to subject
- cannot be conducted otherwise
-IRB approves it
,ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
-trial is not illegal by law
Who reports change of risks to subjects & to whom? - CORRECT ANSWERS PI to
sponsor & IRB & site
Who reports AEs & SAEs / to whom & in what order? - CORRECT ANSWERS PI to 1.
sponsor and then 2. IRB
Premature trial termination should be reported using what schematic? - CORRECT
ANSWERS Termination Vortex
Termination Vortex - CORRECT ANSWERS PI -----> Subjects
Below is a triangle of communication - two way streets with all parties
PI <------> Sponsor
PI <-----> IRB
IRB <------>Sponsor
Who creates SOPs - CORRECT ANSWERS sponsor
Who initiates and secures the agreement? - CORRECT ANSWERS sponsor
A CRO has been enlisted to oversee a study, who is primarily responsible for integrity of trial
data? - CORRECT ANSWERS sponsor
,ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
Expedited reporting of AEs is necessary when what 2 things exist? - CORRECT ANSWERS
Serious & unexpected
Who appoints a monitor? - CORRECT ANSWERS sponsor
Who acts as main point of contact b/w the PI & sponsor? - CORRECT ANSWERS
monitor
Monitor should conduct monitoring visits according to what, created by whom? - CORRECT
ANSWERS SOPs / monitoring specifics, by the sponsor
Audits differ from monitoring visits because - CORRECT ANSWERS monitoring visits
assess safety of subjects and day to day data collection & source documents. audits look for
compliance with approved protocols
Monitors & Auditors differ in what major way? - CORRECT ANSWERS monitors are
supplied by sponsor as part of sponsor team. Auditors are independent.
An untoward event in a patient or clinical investigational subject administered a pharmaceutical
product which does not necessarily have a causal relationship is what? - CORRECT
ANSWERS Adverse event
an adverse drug reaction requires what level of causality? - CORRECT ANSWERS
reasonable possibility
ADRs should be expeditiously reported when what two factors are present? - CORRECT
ANSWERS serious/unexpected
, ACRP CCRC QUESTIONS AND ANSWERS LATEST DOWNLOADED
2025/2026 A COMPLETE EXAM SOLUTION WITH 100%
CORRECT DETAILED ANSWERS BEST GRADED TO SCORE A+
FOR SUCCESS
fatal / life threatening ADRs should be submitted in what time frame? - CORRECT
ANSWERS no later than 7 days, but ASAP
Other serious, but non-fatal / life-threatening ADRs should be reported in what time frame? -
CORRECT ANSWERS ASAP, no more than 15 days
A protocol requires that subjects in a hypertension trial have two consecutive sitting diastolic
blood pressure readings performed and the average of the two recorded on the CRF. The CRA
discovers that only one blood pressure reading is recorded in the source documents, which is
the same as the reading recorded in the CRF for the 10 enrolled subjects. Which of the
following would the CRC expect the CRA to do FIRST?
A. Contac the sponsor's medical monitor to report that the investigator is noncompliant with
the protocol.
B. Notify the data management department that the CRF entries are incorrect and may need to
be queried.
C. Ask the investigator if the blood pressure procedure outlined in the protocol is being
followed.
D. Contact the sponsor's medical monitor to discuss closing the site due to 10 protocol
violations. - CORRECT ANSWERS C
Reason: It is reasonable for the CRC to anticipate the CRA asking the investigator for an
explanation regarding study procedure in this case. However, as it appears that the site is both
noncompliant with the protocol (only one blood pressure check) and documenting the same
result in several patient charts, falsification of data would be a legitimate concern of the CRA,
who would document the finding in a routine monitoring report and closely watch it further as
the study progresses. Following such a discussion with the investigator, the medical monitor
may be notified so that the situation could be examined accordingly.
