ACRP CCRC UPDATED ACTUAL
QUESTIONS AND CORRECT ANSWERS FULL
SOLUTION
⩥ What should be the first consideration when conducting a clinical
trial?
Answer: Subject welfare
⩥ When is the investigator allowed to deviate from the protocol?
Answer: When there is an immediate hazard to a patient.
⩥ If the investigator wanted to deviate from the protocol for an
immediate hazard to a patient, according to ICH E6 guidelines who
world they need to report the deviation and rationale to, if appropriate?
Answer: - The Sponsor
- IRB/IEC
- Regulatory Authorities
⩥ Which conditions should be fulfilled when enrolling a subject into
your trial?
Answer: - Subject meets all inclusion criteria
- Subject has given written informed consent
,⩥ You've been delegated to handle the storage and inventory of IP. The
study drug must be stored below 25C/77F. On a summer Monday
morning you discover that the temperature recording machine in the
storage room has failed so you doin't know what the temperature has
been over the weekend. You check the current temperature; it's 24C/75F.
What should you do?
Answer: - Contact the Sponsor, explain what happened and ask for
instructions
- Set up a site staff meeting to conduct a root cause analysis
⩥ A protocol amendment was issued for a trial. Your site received IRB
approval for the amendment and wants to implement the increase in PO
dose for your trial subjects as identified in the amendment trial subjects.
As delegated consenting duties you must re-consent trial subjects before
being able to administer the adjusted dose. You decide to only re-consent
trial subjects who are still taking the IP and not from the subjects woh
already completed their drug intake period. Is this allowed according the
E6 Guideline for GCP?
Answer: No, these subjects are still enrolled in the trial and therefore
need to be updated on any changes to the protocol.
⩥ A trial subject informs you she no longer wants to participant in the
trial. What should your course of action be?
Answer: You ask if the patient wishes to share the reason why she wants
to leave the trial. If not, you exclude the subject from the trial
immediately.
,⩥ A patient cannot recall the name of the heart condition medication he
took a few years ago. This is important information for deciding whether
the patient may be enrolled in a clinical trial (IC/EC). What's your best
course of action?
Answer: You attempt to retrieve the patients medical history by
contacting previous caregivers and you wait for additional information
before enrollment.
⩥ Who has ultimate trial responsibility for each subject?
Answer: The principle investigator.
⩥ A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB?
Answer: No
⩥ What statements are true concerning an adverse drug reaction?
Answer: - All noxious and unintended responses to a medicinal product
related to any dose should be considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
⩥ What Adverse Events (AEs) are Serious Adverse Events (SAEs)?
Answer: - Any AE that results in death
- Any AE that results in inpatient hospitalization
, - Any AE that is a congenital anomaly
⩥ During a study visit a patient tells the investigator that she visited an
emergency room and received intensive treatment for allergic
bronchospasm. Since the patient was in the emergency room for only
three hours, the investigator did not assess the event as serious. Is this a
correct assessment?
Answer: No, this would be a medically important event and should be
considered serious
⩥ What data points minimally need to be reported by the site when
reporting an SAE, so that the sponsor can process the event?
Answer: Identification of event, product, and trial subject
⩥ During a visit with investigator, a subject reported feeling heart
palpitations for a brief period of time during the previous evening. The
heart palpitations resolved without reoccurrence. The investigator
considered these symptoms to be unrelated to study drug. The next day,
the subject told a fellow student that he felt tired and was planning on
taking a nap. Later, the subject was found dead. A preliminary report
from the medical examiner indicated the subject died of pulmonary
embolism. What should your next course of action be?
Answer: - Record these events in case report form
- Immediately notify sponsor about serious adverse events
QUESTIONS AND CORRECT ANSWERS FULL
SOLUTION
⩥ What should be the first consideration when conducting a clinical
trial?
Answer: Subject welfare
⩥ When is the investigator allowed to deviate from the protocol?
Answer: When there is an immediate hazard to a patient.
⩥ If the investigator wanted to deviate from the protocol for an
immediate hazard to a patient, according to ICH E6 guidelines who
world they need to report the deviation and rationale to, if appropriate?
Answer: - The Sponsor
- IRB/IEC
- Regulatory Authorities
⩥ Which conditions should be fulfilled when enrolling a subject into
your trial?
Answer: - Subject meets all inclusion criteria
- Subject has given written informed consent
,⩥ You've been delegated to handle the storage and inventory of IP. The
study drug must be stored below 25C/77F. On a summer Monday
morning you discover that the temperature recording machine in the
storage room has failed so you doin't know what the temperature has
been over the weekend. You check the current temperature; it's 24C/75F.
What should you do?
Answer: - Contact the Sponsor, explain what happened and ask for
instructions
- Set up a site staff meeting to conduct a root cause analysis
⩥ A protocol amendment was issued for a trial. Your site received IRB
approval for the amendment and wants to implement the increase in PO
dose for your trial subjects as identified in the amendment trial subjects.
As delegated consenting duties you must re-consent trial subjects before
being able to administer the adjusted dose. You decide to only re-consent
trial subjects who are still taking the IP and not from the subjects woh
already completed their drug intake period. Is this allowed according the
E6 Guideline for GCP?
Answer: No, these subjects are still enrolled in the trial and therefore
need to be updated on any changes to the protocol.
⩥ A trial subject informs you she no longer wants to participant in the
trial. What should your course of action be?
Answer: You ask if the patient wishes to share the reason why she wants
to leave the trial. If not, you exclude the subject from the trial
immediately.
,⩥ A patient cannot recall the name of the heart condition medication he
took a few years ago. This is important information for deciding whether
the patient may be enrolled in a clinical trial (IC/EC). What's your best
course of action?
Answer: You attempt to retrieve the patients medical history by
contacting previous caregivers and you wait for additional information
before enrollment.
⩥ Who has ultimate trial responsibility for each subject?
Answer: The principle investigator.
⩥ A trial subject suffers from severe repeat headaches. Should this
adverse event be reported to the IRB?
Answer: No
⩥ What statements are true concerning an adverse drug reaction?
Answer: - All noxious and unintended responses to a medicinal product
related to any dose should be considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
⩥ What Adverse Events (AEs) are Serious Adverse Events (SAEs)?
Answer: - Any AE that results in death
- Any AE that results in inpatient hospitalization
, - Any AE that is a congenital anomaly
⩥ During a study visit a patient tells the investigator that she visited an
emergency room and received intensive treatment for allergic
bronchospasm. Since the patient was in the emergency room for only
three hours, the investigator did not assess the event as serious. Is this a
correct assessment?
Answer: No, this would be a medically important event and should be
considered serious
⩥ What data points minimally need to be reported by the site when
reporting an SAE, so that the sponsor can process the event?
Answer: Identification of event, product, and trial subject
⩥ During a visit with investigator, a subject reported feeling heart
palpitations for a brief period of time during the previous evening. The
heart palpitations resolved without reoccurrence. The investigator
considered these symptoms to be unrelated to study drug. The next day,
the subject told a fellow student that he felt tired and was planning on
taking a nap. Later, the subject was found dead. A preliminary report
from the medical examiner indicated the subject died of pulmonary
embolism. What should your next course of action be?
Answer: - Record these events in case report form
- Immediately notify sponsor about serious adverse events
