ACRP CCRC exam| 70 QUESTIONS|
ANSWERS ALL CORRECT
The _________ has developed the Declaration of Helsinki (DoH): Correct Answer: World
Medical Association; as a statement of ethical principles to provide guidance to physicians and
other participats in medical research involving human subjects.
(DoH) It is the duty of ________________ in medical research to protect the life, health, privacy
and dignity of the human subject. Correct Answer: the physician
(DoH) In medical research, societal/scientific interest should always be prioritized after: Correct
Answer: prioritization of the subject's health and well being
(DoH) The primary purpose of medical research involving human subjects is to: 2 part answer...
Correct Answer: 1) improve prophylactic, diagnostic and therapeutic procedures
2) improve the understanding of the aetiology and pathogenesis of disease
(DoH) The _________________________________ must be independent of the investigator, the
sponsor or any other kind of undue influence. Correct Answer: Institutional Review
Board/Committee
(DoH) The physician should cease any investigation if: Correct Answer: the risks are found to
outweigh the potential benefits.
(DoH) What is obtained in the place of 'consent' when the subject is deemed legally incompetent
(such as a child)? Correct Answer: 1) obtain the subject's assent
2) obtain the subject's legally authorized representative's consent
(ICH-E2A) Definition of Adverse Event (or Adverse Experience)(AE): Correct Answer: any
untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have to have a causal relationship with
this treatment .
(ICH-E2A) Definition of Adverse Drug Reaction (ADR): Correct Answer: all noxious and
unintended responses to a medicinal product related to any dose should be considered adverse
drug reactions.
(ICH-E2A) Examples of Adverse Events: Correct Answer: abnormal laboratory finding,
symptom or disease; "any unfavorable and unintended sign"
(ICH-E2A) What term is NOT synonymous with adverse event and should no longer be used?
Correct Answer: side effect
,(ICH-E2A) Definition of Unexpected Adverse Drug reaction? Correct Answer: an adverse
reaction, the nature or severity of which is not consistent with the applicable product information
(e.g. Investigator Brochure).
(ICH-E2A) Definition of Serious Adverse Event: Correct Answer: any untoward medical
occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization
or prolongation of existing hospitalization, results in persistent or significant
disability/incapacity, or is a congenital anomaly/birth defect.
(ICH-E2A) In regards to SAEs, what does the term 'life-threatening' mean? Correct Answer: an
event in which the patient was at risk of death at the time of the event; (it does not refer to an
event which hypothetically might have caused death if it were more severe)
(ICH-E2A) Regarding SAEs, differentiate the difference between the terms 'serious' and 'severe':
Correct Answer: Serious: seriousness is determined by the outcome (think of the definition of
SAE)
Severity: used to describe the intensity of a specific event (as in mild, moderate, or severe
myocardial infarction)
Example: a headache can be severe, but is not 'serious' until it results in either death,
hospitalization/prolonged hospitalization, birth defect, significant disability.
(ICH-E2A) What documents should be used to determine whether an adverse event is expected
or unexpected? Correct Answer: 1) Investigator's Brochure
2) Reports which add significant information on specificity or severity of a known, already
documented serious ADR constitute unexpected events
Example: an acute renal failure as a labeled ADR with a subsequent new report of interstitial
nephritis.
According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal
or life-threatening unexpected ADR's (adverse drug reaction)? Correct Answer: ≤ 7 calendar
days.
"As soon as possible, but no later than 7 calendar days after first knowledge by the sponsor."
According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal
or life-threatening unexpected ADR FOLLOW UP REPORT? Correct Answer: Within 8
additional calendar days.
Follow-up must include an assessment of the importance and implication of the findings,
including relevant previous experience with the same or similar medicinal products.
According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for all
other serious, unexpected ADR's? Correct Answer: ≤ 15 calendar days.
, "As soon as possible, but no later than 15 calendar days after first knowledge by the sponsor."
A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion which
results in an inpatient hospitalization. Nausea with vomiting does not appear in the Investigator's
Brochure. The investigator should rate this event as: Correct Answer: A. expected and serious.
B. expected and not serious.
C. unexpected and serious.
D. unexpected and not serious.
(C)
Which of the following documents are required to be present in the investigator's trial files at the
end of the trial? Correct Answer: 1. subject enrollment logs
2. IP certificate of analysis
3. sample of labels affixed to IP containers
4. investigator notification of new IP safety information
A. 1 and 3 only
B. 1 and 4 only
C. 2 and 3 only
D. 2 and 4 only
(B)
A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic
IP. The sponsor expects to enroll 20 subjects. This would be considered a: Correct Answer: A.
Phase I trial.
B. Phase II trial.
C. Phase III trial.
D. Phase IV trial
(A)
A subject has a history of dermatitis. During visit 2 of the trial, the subject complained of a rash.
The investigator interrupted the use of the IP and the rash disappeared. At the next visit, the IP
was restarted. One day later, the rash reappeared. The investigator discontinued the subject from
the trial. The causality can be determined as probably related to the IP based on: Correct Answer:
A. the placebo effect.
B. a positive rechallenge.
C. insufficient information.
D. the history of dermatitis.
ANSWERS ALL CORRECT
The _________ has developed the Declaration of Helsinki (DoH): Correct Answer: World
Medical Association; as a statement of ethical principles to provide guidance to physicians and
other participats in medical research involving human subjects.
(DoH) It is the duty of ________________ in medical research to protect the life, health, privacy
and dignity of the human subject. Correct Answer: the physician
(DoH) In medical research, societal/scientific interest should always be prioritized after: Correct
Answer: prioritization of the subject's health and well being
(DoH) The primary purpose of medical research involving human subjects is to: 2 part answer...
Correct Answer: 1) improve prophylactic, diagnostic and therapeutic procedures
2) improve the understanding of the aetiology and pathogenesis of disease
(DoH) The _________________________________ must be independent of the investigator, the
sponsor or any other kind of undue influence. Correct Answer: Institutional Review
Board/Committee
(DoH) The physician should cease any investigation if: Correct Answer: the risks are found to
outweigh the potential benefits.
(DoH) What is obtained in the place of 'consent' when the subject is deemed legally incompetent
(such as a child)? Correct Answer: 1) obtain the subject's assent
2) obtain the subject's legally authorized representative's consent
(ICH-E2A) Definition of Adverse Event (or Adverse Experience)(AE): Correct Answer: any
untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have to have a causal relationship with
this treatment .
(ICH-E2A) Definition of Adverse Drug Reaction (ADR): Correct Answer: all noxious and
unintended responses to a medicinal product related to any dose should be considered adverse
drug reactions.
(ICH-E2A) Examples of Adverse Events: Correct Answer: abnormal laboratory finding,
symptom or disease; "any unfavorable and unintended sign"
(ICH-E2A) What term is NOT synonymous with adverse event and should no longer be used?
Correct Answer: side effect
,(ICH-E2A) Definition of Unexpected Adverse Drug reaction? Correct Answer: an adverse
reaction, the nature or severity of which is not consistent with the applicable product information
(e.g. Investigator Brochure).
(ICH-E2A) Definition of Serious Adverse Event: Correct Answer: any untoward medical
occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization
or prolongation of existing hospitalization, results in persistent or significant
disability/incapacity, or is a congenital anomaly/birth defect.
(ICH-E2A) In regards to SAEs, what does the term 'life-threatening' mean? Correct Answer: an
event in which the patient was at risk of death at the time of the event; (it does not refer to an
event which hypothetically might have caused death if it were more severe)
(ICH-E2A) Regarding SAEs, differentiate the difference between the terms 'serious' and 'severe':
Correct Answer: Serious: seriousness is determined by the outcome (think of the definition of
SAE)
Severity: used to describe the intensity of a specific event (as in mild, moderate, or severe
myocardial infarction)
Example: a headache can be severe, but is not 'serious' until it results in either death,
hospitalization/prolonged hospitalization, birth defect, significant disability.
(ICH-E2A) What documents should be used to determine whether an adverse event is expected
or unexpected? Correct Answer: 1) Investigator's Brochure
2) Reports which add significant information on specificity or severity of a known, already
documented serious ADR constitute unexpected events
Example: an acute renal failure as a labeled ADR with a subsequent new report of interstitial
nephritis.
According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal
or life-threatening unexpected ADR's (adverse drug reaction)? Correct Answer: ≤ 7 calendar
days.
"As soon as possible, but no later than 7 calendar days after first knowledge by the sponsor."
According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal
or life-threatening unexpected ADR FOLLOW UP REPORT? Correct Answer: Within 8
additional calendar days.
Follow-up must include an assessment of the importance and implication of the findings,
including relevant previous experience with the same or similar medicinal products.
According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for all
other serious, unexpected ADR's? Correct Answer: ≤ 15 calendar days.
, "As soon as possible, but no later than 15 calendar days after first knowledge by the sponsor."
A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion which
results in an inpatient hospitalization. Nausea with vomiting does not appear in the Investigator's
Brochure. The investigator should rate this event as: Correct Answer: A. expected and serious.
B. expected and not serious.
C. unexpected and serious.
D. unexpected and not serious.
(C)
Which of the following documents are required to be present in the investigator's trial files at the
end of the trial? Correct Answer: 1. subject enrollment logs
2. IP certificate of analysis
3. sample of labels affixed to IP containers
4. investigator notification of new IP safety information
A. 1 and 3 only
B. 1 and 4 only
C. 2 and 3 only
D. 2 and 4 only
(B)
A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic
IP. The sponsor expects to enroll 20 subjects. This would be considered a: Correct Answer: A.
Phase I trial.
B. Phase II trial.
C. Phase III trial.
D. Phase IV trial
(A)
A subject has a history of dermatitis. During visit 2 of the trial, the subject complained of a rash.
The investigator interrupted the use of the IP and the rash disappeared. At the next visit, the IP
was restarted. One day later, the rash reappeared. The investigator discontinued the subject from
the trial. The causality can be determined as probably related to the IP based on: Correct Answer:
A. the placebo effect.
B. a positive rechallenge.
C. insufficient information.
D. the history of dermatitis.
