GOOD CLINICAL PRACTICE ICH EXAM SCRIPT
2026 QUESTIONS WITH SOLUTIONS GRADED
A+
◉ When correcting data, documentation must include:
A. the original entry with strike-out, the new entry, and the name or
initials of the individual making the change
B. the original entry with strike-out, the new entry, the date of
change, the name or initials of the individual making the change, and
the reason for the change
C. the original entry with strike out, the new entry, and the date of
change. Answer: B. the original entry with strike-out, the new entry,
the date of change, the name or initials of the individual making the
change, and the reason for the change
◉ (select all that apply) A serious adverse event is defined as an
adverse event that:
A. is related to the investigational product
B. results in a persistent disability
C. is not life-threatening
,D. requires inpatient hospitalization or prolongation of existing
hospitalization. Answer: B and D
B. results in a persistent disability
D. requires inpatient hospitalization or prolongation of existing
hospitalization
◉ When should delegated site staff receive training on the clinical
trial protocol?
A. before performing the relevant clinical trial activity
B. before signing the financial agreement with the sponsor/CRO
C. within 30 days of receiving IRB/IEC protocol approval. Answer: A.
before performing the relevant clinical trial activity
◉ (select all that apply) As an Investigator, which of the following
tasks can you appropriately delegate to a non-physician Study
Coordinator?
A. filing trial documents in the Investigator Site File
B. assessing adverse events
C. administering protocol-required quality-of-life questionnaires.
Answer: A and C
,A. filing trial documents in the Investigator Site File
C. administering protocol-required quality-of-life questionnaires
◉ (select all that apply) Which of the following are considered
adverse events?
A. the participant has clinically significant changes in liver function
tests
B. a participant reports more frequent headaches than they had
prior to starting the trial
C. a participant reports slight bruising following a blood draw
(venipuncture) after randomization. Answer: All of the above (A, B,
and C)
◉ (select all that apply) The Investigator must promptly report to
the IRB/IEC:
A. failure to meet a monthly enrollment target
B. any change that significantly affects the conduct of the trial
C. all suspected unexpected serious adverse reaction (SUSARs) in
accordance with applicable regulatory requirements. Answer: B and
C
B. any change that significantly affects the conduct of the trial
, C. all suspected unexpected serious adverse reaction (SUSARs) in
accordance with applicable regulatory requirements
◉ As an Investigator, you no longer have space to store clinical trial
records due to economic hardship. What should you do?
A. maintain source records but destroy the investigator copy of the
case report forms
B. arrange storage at hospital's secure, off-site storage facility
C. store records at home. Answer: B. arrange storage at hospital's
secure, off-site storage facility
◉ (select all that apply) Which of the following should be confirmed
by the Monitor if a participant requests to transfer to another
investigative site?
A. certified copies of the participants source records are provided to
the new investigator
B. all queries are closed at the original site
C. all investigational products are retrieved from the participant
prior to transfer. Answer: A and B
A. certified copies of the participants source records are provided to
the new investigator
2026 QUESTIONS WITH SOLUTIONS GRADED
A+
◉ When correcting data, documentation must include:
A. the original entry with strike-out, the new entry, and the name or
initials of the individual making the change
B. the original entry with strike-out, the new entry, the date of
change, the name or initials of the individual making the change, and
the reason for the change
C. the original entry with strike out, the new entry, and the date of
change. Answer: B. the original entry with strike-out, the new entry,
the date of change, the name or initials of the individual making the
change, and the reason for the change
◉ (select all that apply) A serious adverse event is defined as an
adverse event that:
A. is related to the investigational product
B. results in a persistent disability
C. is not life-threatening
,D. requires inpatient hospitalization or prolongation of existing
hospitalization. Answer: B and D
B. results in a persistent disability
D. requires inpatient hospitalization or prolongation of existing
hospitalization
◉ When should delegated site staff receive training on the clinical
trial protocol?
A. before performing the relevant clinical trial activity
B. before signing the financial agreement with the sponsor/CRO
C. within 30 days of receiving IRB/IEC protocol approval. Answer: A.
before performing the relevant clinical trial activity
◉ (select all that apply) As an Investigator, which of the following
tasks can you appropriately delegate to a non-physician Study
Coordinator?
A. filing trial documents in the Investigator Site File
B. assessing adverse events
C. administering protocol-required quality-of-life questionnaires.
Answer: A and C
,A. filing trial documents in the Investigator Site File
C. administering protocol-required quality-of-life questionnaires
◉ (select all that apply) Which of the following are considered
adverse events?
A. the participant has clinically significant changes in liver function
tests
B. a participant reports more frequent headaches than they had
prior to starting the trial
C. a participant reports slight bruising following a blood draw
(venipuncture) after randomization. Answer: All of the above (A, B,
and C)
◉ (select all that apply) The Investigator must promptly report to
the IRB/IEC:
A. failure to meet a monthly enrollment target
B. any change that significantly affects the conduct of the trial
C. all suspected unexpected serious adverse reaction (SUSARs) in
accordance with applicable regulatory requirements. Answer: B and
C
B. any change that significantly affects the conduct of the trial
, C. all suspected unexpected serious adverse reaction (SUSARs) in
accordance with applicable regulatory requirements
◉ As an Investigator, you no longer have space to store clinical trial
records due to economic hardship. What should you do?
A. maintain source records but destroy the investigator copy of the
case report forms
B. arrange storage at hospital's secure, off-site storage facility
C. store records at home. Answer: B. arrange storage at hospital's
secure, off-site storage facility
◉ (select all that apply) Which of the following should be confirmed
by the Monitor if a participant requests to transfer to another
investigative site?
A. certified copies of the participants source records are provided to
the new investigator
B. all queries are closed at the original site
C. all investigational products are retrieved from the participant
prior to transfer. Answer: A and B
A. certified copies of the participants source records are provided to
the new investigator
