ACRP Certified Clinical EXAM COVERAGE
Research Coordinator (CCRC)
exam CLINICAL RESEARCH COORDINATION
ROLES AND RESPONSIBILITIES
CLINICAL TRIAL DESIGN, PHASES, AND
STUDY TYPES
ETHICAL AND REGULATORY
REQUIREMENTS (IRB, FDA, ICH-GCP)
INFORMED CONSENT PROCESS AND
PARTICIPANT RIGHTS
STUDY PROTOCOL IMPLEMENTATION
AND ADHERENCE
SUBJECT RECRUITMENT, SCREENING, AND
ENROLLMENT PROCEDURES
DATA COLLECTION, MANAGEMENT, AND
QUALITY ASSURANCE
SAFETY REPORTING, ADVERSE EVENT
, DOCUMENTATION, AND MONITORING
INTERACTIONS WITH SPONSORS,
INVESTIGATORS, AND RESEARCH STAFF
PROFESSIONALISM, ETHICS, AND
CONTINUOUS EDUCATION IN CLINICAL
RESEARCH
A subject is issued 120 tablets 50%
and is instructed to take 2
tablets 4 times a day. He returns
88 tablets on the morning of
day 9 fasting for laboratory
tests. What percent compliant is
he?
,Twenty-six subjects were 92
enrolled in a pneumonia trial.
The site received 100 bottles of
IP. Each subject received two
bottles. Four subjects did not
return their trial bottles. How
many bottles are available for
the CRC to return to the
sponsor at the end of the trial?
, A subject is participating in a double-blind
clinical trial where only the
pharmacist and the sponsor
know the identity of the IP. The
pharmacist has no direct
contact with the trial subject
and the clinical team. Which of
the following BEST describes
this trial type?
double-blind trial study where participants and the study
team interacting with them (investigator, arc)
are unaware of treatment allocation
Research Coordinator (CCRC)
exam CLINICAL RESEARCH COORDINATION
ROLES AND RESPONSIBILITIES
CLINICAL TRIAL DESIGN, PHASES, AND
STUDY TYPES
ETHICAL AND REGULATORY
REQUIREMENTS (IRB, FDA, ICH-GCP)
INFORMED CONSENT PROCESS AND
PARTICIPANT RIGHTS
STUDY PROTOCOL IMPLEMENTATION
AND ADHERENCE
SUBJECT RECRUITMENT, SCREENING, AND
ENROLLMENT PROCEDURES
DATA COLLECTION, MANAGEMENT, AND
QUALITY ASSURANCE
SAFETY REPORTING, ADVERSE EVENT
, DOCUMENTATION, AND MONITORING
INTERACTIONS WITH SPONSORS,
INVESTIGATORS, AND RESEARCH STAFF
PROFESSIONALISM, ETHICS, AND
CONTINUOUS EDUCATION IN CLINICAL
RESEARCH
A subject is issued 120 tablets 50%
and is instructed to take 2
tablets 4 times a day. He returns
88 tablets on the morning of
day 9 fasting for laboratory
tests. What percent compliant is
he?
,Twenty-six subjects were 92
enrolled in a pneumonia trial.
The site received 100 bottles of
IP. Each subject received two
bottles. Four subjects did not
return their trial bottles. How
many bottles are available for
the CRC to return to the
sponsor at the end of the trial?
, A subject is participating in a double-blind
clinical trial where only the
pharmacist and the sponsor
know the identity of the IP. The
pharmacist has no direct
contact with the trial subject
and the clinical team. Which of
the following BEST describes
this trial type?
double-blind trial study where participants and the study
team interacting with them (investigator, arc)
are unaware of treatment allocation
