CRCR EXAM MULTIPLE CHOICE, CRCR Exam Prep, Certified Revenue Cycle Representative - CRCR (2021)
What are collection agency fees based on? - Answer-A percentage of dollars collected
Self-funded benefit plans may choose to coordinate benefits using the gender rule or what other rule? - Answer-B...
CCRC Certification Exam
adverse event/adverse experience (AE) - Answer-- an unexpected medical occurence in a patient or clinical
investigation subject administered a pharmaceutical product
- it does not have to have a causal relationship with this treatment
- includes any unfavorable, unintended sign, symptom, or disease realted with the use of a medicinal product,
whether or not considered related to the medicinal product
adverse drug reaction (ADR) - Answer-- In pre-approval clinical experience with a new medicinal product that does
not yet have therapeutic doses established: all noxious and unintended responses to a medicinal product (cannot
completely rule out the drug) related to any dose should be considered adverse drug reactions
- In marketed medicinal products, an ____ is a response to a drug which is noxious and unintended and which occurs
at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or modification of physiological
function
Unexpected adverse drug reaction - Answer-an adverse reaction in which the nature or severity is not consistent with
the applicable production information (IB for an unapproved investigational medicinal product)
serious adverse event/experience (SAE) - Answer-any untoward medical occurence that at any dose:
- results in death
- life-threatening (patient was at risk of death at time of event)
- requires inpatient hospitlization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- is a congential anomaly/birth defect
- important medical events that may not immediately be life-threatening but could result in death or hospitalization but
may require intervention in order to not lead to the events above
what serves as the source document adverse events associated with a drug not yet approved for marketing in a
country? - Answer-the investigator brochure (IB)
T/F: Reports that add significant information on specificity or severity of a known, already documented serious ADR
make up unexpected events - Answer-True
T/F: all adverse drug reactions that are serious and unexpected are subject to expedited reporting (This includes
reports from spontaneous sources and from any type of clinical or epidemiological investigation. It also includes
cases not reported directly to a sponsor or manufacturer (regulatory authority-generated ADR registries or in
publication). - Answer-true
Cases for expedited reporting is inappropriate (still need to be reported to sponsor) - Answer-- serious reactions that
are expected
- serious events (expected or not expected) deemed unrelated to medicinal products
- non-serious AEs (expected or not expected)
T/F: all cases judged by either the reporting health care professional or the sponsor as having a reasonable
suspected causal relationship to the medicinal produc qualify as ADRs - Answer-true
Situations that may require rapid communication to regulatory authorities. Pertains to situations that might influence
the benefit-risk assessment of a medicinal product or that could changed administration or overall conduct of a
clinical investigation - Answer-- For an expected, serious ADR, an increase in rate of occurrrence which is thought to
be clinically important
- A significant hazard to patient population (i.e. lack of efficacy with a product used in treating life-threatening disease
- major safety finding from a newly completed animal study
T/F: fatal or life-threatening unexpected ADRs occuring in clinical investigations qualify for RAPID reporting and
should be notified by phone, facsimile transmission or writing ASAP but no later than 7 days after first knowledge by
the sponsor with a complete report in 8 days - Answer-true
T/F: serious, unexpected reactions that are not fatal or life-threatening must be filed ASAP but no later than 15 days
after first knowledge of sponsor - Answer-true
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