ACRP-CP CERTIFICATION ELITE REVIEW STUDY
PAPER 100% GUARANTEED PASS
◉Severe vs seriousness . Answer: o Severe headache but not serious
(something life threatening)
o Severe is intensity mild, moderate, severe
o Serious is event outcome the impact on the patient
- Events that could threaten life and function
◉5 things needed to classify an AE . Answer: Death,
hospitalization/extends hospital stay, disability, life threatening, birth
defect/ congenital anomaly
◉When is an event unexpected . Answer: When it is not listed in the IB
◉For serious AE what is the time frame to report . Answer: o 7
calendars days for initial reports and 8 calendar days for the follow up
report
◉When should non-threatning AE be reported . Answer: 15 Days
,◉What are the minimum criteria for reporting [4] . Answer: identifiable
patient, suspect of medicinal product, identifiable report source, serious
and unexpected event
◉What AE should be reported . Answer: o Related, serious, and
unexpected
o These are the ones that we have to report
§ May have to report trends, or patterns, AE occurs more freq., is drug
not working, new animal study reveals something alarming
(carcinogenic effect)
◉When should the blind be broken
- extra for expedited reporting . Answer: o Don't break it unless you
must, to treat participant etc
o Guidance says sponsors breaks the blind only for the specific pt, only
the people who have to do the report or treat the patient, not broken for
all participants just the one that needs it
§ For expedited reporting only the sponsor breaks it
◉- What happens if the SAE is associate with the IP . Answer: For the
active comparator it is the sponsor responsibility. Be reported to
manufacture or appropriate reg agency
◉- How are post study SAEs reported . Answer: Follow normal process
as guidelines during active study
, ◉At what stage in the clinical trial process should pediatric patients be
involved . Answer: CLEAR AND PRESENT NEED
for diseases that affect children
For serious or life threatening diseases affect both adults and kids
medicines for less urgent conditions
◉What is pharmacokinetic . Answer: looking at what the body does to
the drug, how the drug moves through the body, ADME absorption,
distribution, metabolism, excretion
◉Age classifications for pediatrics . Answer: preterm newborn infants
term newborn infants 0-27 days
infants and toddlers 28 days - 3 months
Children 2 - 11 years
Adolescents 12 to 16 or 18 years
◉General Considerations for Clinical Studies . Answer: Research - Ask
important questions and answer with appropriate studies
Primary Objectives - must reflect the research question and be clear and
explicitly stated
Study Design - must be designed, planned, conducted, analyzed, and
reported according to sound scientific principles
PAPER 100% GUARANTEED PASS
◉Severe vs seriousness . Answer: o Severe headache but not serious
(something life threatening)
o Severe is intensity mild, moderate, severe
o Serious is event outcome the impact on the patient
- Events that could threaten life and function
◉5 things needed to classify an AE . Answer: Death,
hospitalization/extends hospital stay, disability, life threatening, birth
defect/ congenital anomaly
◉When is an event unexpected . Answer: When it is not listed in the IB
◉For serious AE what is the time frame to report . Answer: o 7
calendars days for initial reports and 8 calendar days for the follow up
report
◉When should non-threatning AE be reported . Answer: 15 Days
,◉What are the minimum criteria for reporting [4] . Answer: identifiable
patient, suspect of medicinal product, identifiable report source, serious
and unexpected event
◉What AE should be reported . Answer: o Related, serious, and
unexpected
o These are the ones that we have to report
§ May have to report trends, or patterns, AE occurs more freq., is drug
not working, new animal study reveals something alarming
(carcinogenic effect)
◉When should the blind be broken
- extra for expedited reporting . Answer: o Don't break it unless you
must, to treat participant etc
o Guidance says sponsors breaks the blind only for the specific pt, only
the people who have to do the report or treat the patient, not broken for
all participants just the one that needs it
§ For expedited reporting only the sponsor breaks it
◉- What happens if the SAE is associate with the IP . Answer: For the
active comparator it is the sponsor responsibility. Be reported to
manufacture or appropriate reg agency
◉- How are post study SAEs reported . Answer: Follow normal process
as guidelines during active study
, ◉At what stage in the clinical trial process should pediatric patients be
involved . Answer: CLEAR AND PRESENT NEED
for diseases that affect children
For serious or life threatening diseases affect both adults and kids
medicines for less urgent conditions
◉What is pharmacokinetic . Answer: looking at what the body does to
the drug, how the drug moves through the body, ADME absorption,
distribution, metabolism, excretion
◉Age classifications for pediatrics . Answer: preterm newborn infants
term newborn infants 0-27 days
infants and toddlers 28 days - 3 months
Children 2 - 11 years
Adolescents 12 to 16 or 18 years
◉General Considerations for Clinical Studies . Answer: Research - Ask
important questions and answer with appropriate studies
Primary Objectives - must reflect the research question and be clear and
explicitly stated
Study Design - must be designed, planned, conducted, analyzed, and
reported according to sound scientific principles
