ACRP CCRC Exam ACRP EXAM COVERAGE
Certified Clinical 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
What should be the first Subject welfare
consideration when conducting
a clinical trial?
When is the investigator allowed When there is an immediate hazard to a
to deviate from the protocol? patient.
,If the investigator wanted to - The Sponsor
deviate from the protocol for an - IRB/IEC
immediate hazard to a patient, - Regulatory Authorities
according to ICH E6 guidelines
who world they need to report
the deviation and rationale to, if
appropriate?
Which conditions should be - Subject meets all inclusion criteria
fulfilled when enrolling a - Subject has given written informed
subject into your trial? consent
, You've been delegated to - Contact the Sponsor, explain what
handle the storage and happened and ask for instructions
inventory of IP. The study drug - Set up a site staff meeting to conduct a
must be stored below 25C/77F. root cause analysis
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?
Certified Clinical 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
What should be the first Subject welfare
consideration when conducting
a clinical trial?
When is the investigator allowed When there is an immediate hazard to a
to deviate from the protocol? patient.
,If the investigator wanted to - The Sponsor
deviate from the protocol for an - IRB/IEC
immediate hazard to a patient, - Regulatory Authorities
according to ICH E6 guidelines
who world they need to report
the deviation and rationale to, if
appropriate?
Which conditions should be - Subject meets all inclusion criteria
fulfilled when enrolling a - Subject has given written informed
subject into your trial? consent
, You've been delegated to - Contact the Sponsor, explain what
handle the storage and happened and ask for instructions
inventory of IP. The study drug - Set up a site staff meeting to conduct a
must be stored below 25C/77F. root cause analysis
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?
