ACRP CCRC EXAM PREP QUESTIONS AND
ANSWERS 100% CORRECT!!
,What are expected or possible consequences of over-estimation of recruitment
potential? -ANSWER - The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
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.
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
When asked by a regulatory body why they received SAE related information on
12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason
being they received the trial related SAE information from the investigator in 12/2013. Is
the sponsor correct in only holding the investigator accountable for their late reporting? -
ANSWER No, the sponsor should support the conduct QC activities with the sites to
help them ensure timely SAE reporting.
ANSWERS 100% CORRECT!!
,What are expected or possible consequences of over-estimation of recruitment
potential? -ANSWER - The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
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.
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
When asked by a regulatory body why they received SAE related information on
12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason
being they received the trial related SAE information from the investigator in 12/2013. Is
the sponsor correct in only holding the investigator accountable for their late reporting? -
ANSWER No, the sponsor should support the conduct QC activities with the sites to
help them ensure timely SAE reporting.
