2025,,,,ACRP CCRC Exam Prep Exam
Questions & Answers, Well Elaborated |
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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.
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
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, 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
Questions & Answers, Well Elaborated |
Already Verified Test |100% Verified
solutions | Latest!!
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.
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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
