CCRC EXAM NEWEST 2026 ACTUAL EXAM TEST
BANK| COMPLETE 350 REAL EXAM QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED ANSWERS)
GRADED A+| ACRP CCRC EXAM PREP REVIEW
(BRAND NEW!!)
Question 1
A clinical research coordinator (CRC) is reviewing informed
consent with a potential subject. The subject asks, "What happens
if I am injured by this study drug?" Under ICH GCP, what must
the consent form address?
A) The subject will pay for all injury-related care
B) The study sponsor will provide compensation or medical care
for injury
C) The subject cannot sue the research site
D) Injury is not possible in clinical trials
1
,Answer: B
Rationale: ICH GCP E6(R2) Section 4.8.10 requires informed
consent to include a statement that compensation or medical
treatment is available if injury occurs, and where further
information can be obtained. The sponsor is typically responsible.
Question 2
A CRC discovers that a subject missed a required fasting blood
draw at the Week 4 visit but completed all other procedures.
The protocol requires fasting blood draws. What is the correct
action?
A) Do nothing; the subject was non-compliant
B) Document the missed procedure as a protocol deviation and
notify the IRB and sponsor per policy
C) Schedule the subject for a makeup visit immediately
D) Exclude the subject from the study
2
,Answer: B
Rationale: Any deviation from the protocol (including missed
required procedures) must be documented as a protocol
deviation. The CRC must notify the sponsor and IRB according to
site policy and regulatory requirements (21 CFR 312.66).
Question 3
A subject in a double-blind randomized controlled trial
experiences a serious adverse event (SAE) that the investigator
determines is life-threatening and possibly related to the
investigational product. Within what timeframe must the CRC
ensure the sponsor is notified?
A) Within 24 hours of the investigator becoming aware
B) Within 5 calendar days
C) Within 10 business days
D) Within 30 days
3
, Answer: A
Rationale: ICH GCP and FDA regulations require that SAEs that
are life-threatening or fatal be reported to the sponsor within 24
hours of the investigator becoming aware. Non-life-threatening
SAEs within 24-48 hours typically.
Question 4
A CRC is filing source documents in the Investigator Site File (ISF).
Which document must be retained for the longest period
according to ICH GCP?
A) Subject screening logs
B) Signed informed consent forms
C) Investigational product accountability records
D) Correspondence with the IRB
Answer: B
Rationale: ICH GCP Section 4.9.5 requires that essential
4
BANK| COMPLETE 350 REAL EXAM QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED ANSWERS)
GRADED A+| ACRP CCRC EXAM PREP REVIEW
(BRAND NEW!!)
Question 1
A clinical research coordinator (CRC) is reviewing informed
consent with a potential subject. The subject asks, "What happens
if I am injured by this study drug?" Under ICH GCP, what must
the consent form address?
A) The subject will pay for all injury-related care
B) The study sponsor will provide compensation or medical care
for injury
C) The subject cannot sue the research site
D) Injury is not possible in clinical trials
1
,Answer: B
Rationale: ICH GCP E6(R2) Section 4.8.10 requires informed
consent to include a statement that compensation or medical
treatment is available if injury occurs, and where further
information can be obtained. The sponsor is typically responsible.
Question 2
A CRC discovers that a subject missed a required fasting blood
draw at the Week 4 visit but completed all other procedures.
The protocol requires fasting blood draws. What is the correct
action?
A) Do nothing; the subject was non-compliant
B) Document the missed procedure as a protocol deviation and
notify the IRB and sponsor per policy
C) Schedule the subject for a makeup visit immediately
D) Exclude the subject from the study
2
,Answer: B
Rationale: Any deviation from the protocol (including missed
required procedures) must be documented as a protocol
deviation. The CRC must notify the sponsor and IRB according to
site policy and regulatory requirements (21 CFR 312.66).
Question 3
A subject in a double-blind randomized controlled trial
experiences a serious adverse event (SAE) that the investigator
determines is life-threatening and possibly related to the
investigational product. Within what timeframe must the CRC
ensure the sponsor is notified?
A) Within 24 hours of the investigator becoming aware
B) Within 5 calendar days
C) Within 10 business days
D) Within 30 days
3
, Answer: A
Rationale: ICH GCP and FDA regulations require that SAEs that
are life-threatening or fatal be reported to the sponsor within 24
hours of the investigator becoming aware. Non-life-threatening
SAEs within 24-48 hours typically.
Question 4
A CRC is filing source documents in the Investigator Site File (ISF).
Which document must be retained for the longest period
according to ICH GCP?
A) Subject screening logs
B) Signed informed consent forms
C) Investigational product accountability records
D) Correspondence with the IRB
Answer: B
Rationale: ICH GCP Section 4.9.5 requires that essential
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