ACRP Association of Clinical EXAM COVERAGE
Research Professionals CRC
Exam ACTUAL EXAM
CLINICAL RESEARCH COORDINATOR
ROLES, RESPONSIBILITIES, AND
PROFESSIONALISM
CLINICAL TRIAL DESIGN, PHASES, AND
STUDY TYPES
ETHICAL AND REGULATORY
REQUIREMENTS (IRB, FDA, ICH-GCP, AND
LOCAL GUIDELINES)
INFORMED CONSENT PROCESS AND
PROTECTION OF PARTICIPANT RIGHTS
STUDY PROTOCOL IMPLEMENTATION
AND COMPLIANCE MONITORING
SUBJECT RECRUITMENT, SCREENING, AND
ENROLLMENT PROCEDURES
,DATA COLLECTION, MANAGEMENT, AND
QUALITY CONTROL
SAFETY REPORTING, ADVERSE EVENT
DOCUMENTATION, AND FOLLOW-UP
INTERACTIONS WITH INVESTIGATORS,
SPONSORS, AND RESEARCH TEAMS
CONTINUOUS EDUCATION,
PROFESSIONAL DEVELOPMENT, AND
ETHICAL DECISION MAKING
,An adverse event is one which: d) A and B
a) Is an unfavorable and
unintended sign, symptom, or
disease
b) Is one that is temporally
associated with drug regardless
of whether it is related or not
c) A Only
d) A and B
, A subject in an arthritis clinical A) An adverse event
trial develops a severe cold and
flu like symptoms. This event is
most likely classified as:
a) an adverse event
b) an adverse drug reaction
c) an unexpected adverse drug
reaction
d) a serious adverse event
Research Professionals CRC
Exam ACTUAL EXAM
CLINICAL RESEARCH COORDINATOR
ROLES, RESPONSIBILITIES, AND
PROFESSIONALISM
CLINICAL TRIAL DESIGN, PHASES, AND
STUDY TYPES
ETHICAL AND REGULATORY
REQUIREMENTS (IRB, FDA, ICH-GCP, AND
LOCAL GUIDELINES)
INFORMED CONSENT PROCESS AND
PROTECTION OF PARTICIPANT RIGHTS
STUDY PROTOCOL IMPLEMENTATION
AND COMPLIANCE MONITORING
SUBJECT RECRUITMENT, SCREENING, AND
ENROLLMENT PROCEDURES
,DATA COLLECTION, MANAGEMENT, AND
QUALITY CONTROL
SAFETY REPORTING, ADVERSE EVENT
DOCUMENTATION, AND FOLLOW-UP
INTERACTIONS WITH INVESTIGATORS,
SPONSORS, AND RESEARCH TEAMS
CONTINUOUS EDUCATION,
PROFESSIONAL DEVELOPMENT, AND
ETHICAL DECISION MAKING
,An adverse event is one which: d) A and B
a) Is an unfavorable and
unintended sign, symptom, or
disease
b) Is one that is temporally
associated with drug regardless
of whether it is related or not
c) A Only
d) A and B
, A subject in an arthritis clinical A) An adverse event
trial develops a severe cold and
flu like symptoms. This event is
most likely classified as:
a) an adverse event
b) an adverse drug reaction
c) an unexpected adverse drug
reaction
d) a serious adverse event
