ACRP CCRC CERTIFICATION FINAL
TEST 2026 QUESTIONS WITH
CORRECT ANSWERS GRADED A+
◍ ACRP CCRC Exam ACRP Certified Clinical Research Coordinator
(CCRC) exam.
Answer: EXAM COVERAGECLINICAL RESEARCH COORDINATION
ROLES AND RESPONSIBILITIESCLINICAL TRIAL DESIGN,
PHASES, AND STUDY TYPESETHICAL AND REGULATORY
REQUIREMENTS (IRB, FDA, ICH-GCP)INFORMED CONSENT
PROCESS AND PARTICIPANT RIGHTSSTUDY PROTOCOL
IMPLEMENTATION AND ADHERENCESUBJECT RECRUITMENT,
SCREENING, AND ENROLLMENT PROCEDURESDATA
COLLECTION, MANAGEMENT, AND QUALITY
ASSURANCESAFETY REPORTING, ADVERSE EVENT
DOCUMENTATION, AND MONITORINGINTERACTIONS WITH
SPONSORS, INVESTIGATORS, AND RESEARCH
STAFFPROFESSIONALISM, ETHICS, AND CONTINUOUS
EDUCATION IN CLINICAL RESEARCH
◍ Elements of Protocol: Title and Cover Page.
Answer: The title of the IB and any relevant cover page information, such as
the study name, sponsor, and version number.
◍ Elements of Protocol: Table of Contents.
Answer: A list of sections and subsections contained within the IB.
◍ 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.
◍ Elements of Protocol: Introduction.
Answer: A brief overview of the investigational product, including its
purpose and background information.
◍ 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 I
P. The study drug must be stored below 25C/77
F. 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/75
F. 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.
◍ Elements of Protocol: Study Objectives and Protocol.
Answer: A description of the ___________________ and an overview of the
clinical trial ___________________ .
◍ 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.
◍ Elements of Protocol: Investigational Product Description.
Answer: Detailed information about the investigational product, including
its chemical composition, formulation, packaging, and storage requirements.
◍ 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
◍ Elements of Protocol: Pharmacology and Pharmacokinetics.
Answer: Information about the ___________________ of the investigational
product, including its mechanism of action, absorption, distribution,
metabolism, and excretion.
◍ 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
◍ Elements of Protocol: Safety and Toxicology.
Answer: Summary of the ___________________ data from non-clinical
studies, including animal studies and any known adverse effects.
◍ 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
◍ Elements of Protocol: Clinical Studies.
Answer: Summary of the ___________________ conducted with the
investigational product, including study design, patient populations, dosing
regimens, and safety and efficacy results.
◍ 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
TEST 2026 QUESTIONS WITH
CORRECT ANSWERS GRADED A+
◍ ACRP CCRC Exam ACRP Certified Clinical Research Coordinator
(CCRC) exam.
Answer: EXAM COVERAGECLINICAL RESEARCH COORDINATION
ROLES AND RESPONSIBILITIESCLINICAL TRIAL DESIGN,
PHASES, AND STUDY TYPESETHICAL AND REGULATORY
REQUIREMENTS (IRB, FDA, ICH-GCP)INFORMED CONSENT
PROCESS AND PARTICIPANT RIGHTSSTUDY PROTOCOL
IMPLEMENTATION AND ADHERENCESUBJECT RECRUITMENT,
SCREENING, AND ENROLLMENT PROCEDURESDATA
COLLECTION, MANAGEMENT, AND QUALITY
ASSURANCESAFETY REPORTING, ADVERSE EVENT
DOCUMENTATION, AND MONITORINGINTERACTIONS WITH
SPONSORS, INVESTIGATORS, AND RESEARCH
STAFFPROFESSIONALISM, ETHICS, AND CONTINUOUS
EDUCATION IN CLINICAL RESEARCH
◍ Elements of Protocol: Title and Cover Page.
Answer: The title of the IB and any relevant cover page information, such as
the study name, sponsor, and version number.
◍ Elements of Protocol: Table of Contents.
Answer: A list of sections and subsections contained within the IB.
◍ 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.
◍ Elements of Protocol: Introduction.
Answer: A brief overview of the investigational product, including its
purpose and background information.
◍ 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 I
P. The study drug must be stored below 25C/77
F. 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/75
F. 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.
◍ Elements of Protocol: Study Objectives and Protocol.
Answer: A description of the ___________________ and an overview of the
clinical trial ___________________ .
◍ 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.
◍ Elements of Protocol: Investigational Product Description.
Answer: Detailed information about the investigational product, including
its chemical composition, formulation, packaging, and storage requirements.
◍ 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
◍ Elements of Protocol: Pharmacology and Pharmacokinetics.
Answer: Information about the ___________________ of the investigational
product, including its mechanism of action, absorption, distribution,
metabolism, and excretion.
◍ 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
◍ Elements of Protocol: Safety and Toxicology.
Answer: Summary of the ___________________ data from non-clinical
studies, including animal studies and any known adverse effects.
◍ 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
◍ Elements of Protocol: Clinical Studies.
Answer: Summary of the ___________________ conducted with the
investigational product, including study design, patient populations, dosing
regimens, and safety and efficacy results.
◍ 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
