CHRC NEW EXAM WITH ALL QUESTIONS AND CORRECT
ANSWERS 100% VERIFIED!!
(everything you need about CHRC is here) GRADE A+
Risk Assessment - ANSWER The identification, measurement, and prioritization of
relevant events that may have material consequences on the organization to achieve its
objectives.
Internal Controls - ANSWER A process effected by an entity's board of directors,
management, and other personnel designed to provide reasonable assurance regarding
the achievement of objectives.
Combination Products - ANSWER Defined in 21 CFR 3.2(e). The term combination
product includes: A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically,
chemically, or otherwise combined or mixed and produced as a single entity; Two or
more separate products packaged together in a single package or as a unit and
comprised of drug and device products, device and biological products, or biological
and drug products; A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended for use only with
an approved individually specified drug, device, or biological product where both are
required to achieve the intended use, indication, or effect and where upon approval of
the proposed product the labeling of the approved product would need to be changed,
e.g., to reflect a change in intended use, dosage form, strength, route of administration,
or significant change in dose; or Any investigational drug, device, or biological product
packaged separately that according to its proposed labeling is for use only with another
individually specified investigational drug, device, or biological product where both are
required to achieve the intended use, indication, or effect.
IDE stands for Investigational Device Exemptions, the regulations under 21 CFR 812. An
approved IDE simply means that the IRB (and FDA for significant risk devices) has
approved the sponsor's study application and all the requirements under 21 CFR 812
are met.
,Humanitarian Use Devices - ANSWER A medical device intended to benefit patients in
the treatment or diagnosis of a disease or condition that affects or is manifested in not
more than 8,000 individuals in the United States per year
FDA Site Inspections - ANSWER Pre-approval inspections; Routine inspections;
Compliance follow-up inspections; "For cause" inspections.
Assurance Certification - ANSWER Assurance of compliance indicating the the
institution will comply with the terms of the FWA.
Protocol - ANSWER Is a document outlining the design of a study, describing the
objectives, methodology and overall organization of the research to be carried out
forming a template and guide to the research process as a whole.
ICH - International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use; published Good Clinical Practice
Routine Costs - ANSWER Routine costs of a clinical trial are all items and services that
are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit
category, it is not statutorily excluded, and there is not a national non-coverage
decision) that are provided in either the experimental or the control arms of a clinical
trial except: The investigational item or service, itself unless otherwise covered outside
of the clinical trial; Items and services provided solely to satisfy data collection and
analysis needs and that are not used in the direct clinical management of the patient
(e.g., monthly CT scans for a condition usually requiring only a single scan); and Items
and services customarily provided by the research sponsors free-of-charge for any
enrollee in the trial.
Research Coding - ANSWER Z00.6 ICD-10 Diagnosis Code; Q0/Q1 Modifiers; Condition
Code 30 (hospital claims only - research setting); Clinicaltrials.gov registration number
or "NCT" number; Category B ID device HCPCS code if applicable; Condition Code 53
when the investigational device is furnished to the hospital at no cost (outpatient
hospital claims only)
HCPCS Modifier Q0 - ANSWER For the investigational clinical services provided in the
,clinical study
HCPCS Modifier Q1 - ANSWER To routine clinical services in the clinical study
USDA - ANSWER The Animal and Plant Health Inspection Service (APHIS) is a part of
the US Department of Agriculture (USDA) that enforces the AWA. Under the AWA,
organizations or individuals must register with the USDA as "research facilities" if they
plan to use a covered species in research and the research is federally-funded, or the
animals were purchased in commerce. Need to provide annual reports. Live/dead warm
blooded animals. Does not apply to field studies that don't have invasive procedures or
that don't harm or materially alter behavior. 12 hour inspection rule. Annual USDA
inspection. No retaliation for reporting. IACUC semi-annual inspection and program
review.
Office of Laboratory Animal Welfare (OLAW) - ANSWER Oversees the care and use of
research animals in any public or private organization, business, or agency (including
components of Federal, state, and local governments). Provides guidance and
interpretation of the PHS Policy, supports educational programs, and monitors
compliance with the Policy by Assured Institutions and PHS funding components for the
humane care and use of animals in PHS-supported research, testing and training to
enhance the quality of PHS-supported activities. Assurance and Annual Report. Live
vertebrate animals. Covers field studies if alter or influence. 24 hour inspection rule.
IACUC semi-annual inspections and program review.
USDA (highlights for exam) - ANSWER Animal Welfare Act; Live/dead warm blooded
animals; Does not apply to birds, rats, or mice. Does not apply to field studies that don't
have invasive procedures or that don't harm or materially alter behavior; 12 hour
inspection rule; Annual UDSA inspection; No retaliation for reporting; IACUC
semi-annual inspection & program review
OLAW (highlights for exam) - ANSWER Public Health Service Policy; Guide is
applicable; Assurance and Annual Report; Live vertebrate animals; Covers field studies
if alter or influence the activity of the study animals or other species found in the study
area; 24 hour inspection rule; IACUC semi-annual inspection & program review
4 Major Laws for Animal Research- ANSWER 1) US Government Principles for Utilization
and Care of Vertebrate Animals Used in Testing Research and Training; 2) Animal
, Welfare Act (AWA); 3) Public Health Service Policy on Humane Care and Use of
Laboratory Animals; 4) Guide for the Care and Use of Laboratory Animals ("The Guide)
Animal Welfare Act (AWA) - ANSWER Public Health Service Policy on Humane Care
and Use of Laboratory Animals Guide for the Care and Use of Laboratory Animals ("The
Guide")
Animal Research Laws have 3 Rs- ANSWER Refine- methods to minimize animal
suffering and help welfare; Reduce- Methods that minimize number of animals used in
experiments; Replace- methods that avoid or replace the use of animals in experiments
When HHS and FDA Protection of Human Subject Regulations Apply to same study -
ANSWER The IRB and Investigators must apply those specific regulations that offer the
greatest protections to participants.
Institutional Animal Care and Use Committee (IACUC) - ANSWER Is responsible for
oversight of the animal care and use program and its components. Its oversight
functions include an ongoing assessment of animal care and use. Membership shall
include at least 5 members: One veterinarian with training or experience in laboratory
animal science and medicine; One practicing scientist experienced in research with
animals; One member whose primary concerns are in a nonscientific area; One member
who is not affiliated with the institution other than as a member of the IACUC.
Semiannual Inspections. Drafts annual repot to be provided to OLAW via IO. Reports
serious or continuing non-compliance, serious deviation from the Guide, or suspension
of a protocol to OLAW via IO. Reports to USDA via IO any protocol suspension or
significant deficiency not corrected within prescribed period.
Animal Welfare Act (AWA) - ANSWER Signed into law on August 24, 1966. It is the only
Federal law in the United States that regulates the treatment of animals in research,
teaching, testing, exhibition, transport, and by dealers. The Act is enforced by USDA,
APHIS, Animal Care.
When does the AWA apply? - ANSWER Live or dead warm-blooded animals used or
intended for use in research, teaching, testing, experimentation, exhibition, or as pets.
Covers cats, dogs, nonhuman primates (monkey, etc.), guinea pigs, hamsters & rabbits,
and marine mammals. DOES NOT APPLY TO: rats of the genus Rattus or mice of the
genus Mus that are used for research. Birds bred in captivity for use in research are
ANSWERS 100% VERIFIED!!
(everything you need about CHRC is here) GRADE A+
Risk Assessment - ANSWER The identification, measurement, and prioritization of
relevant events that may have material consequences on the organization to achieve its
objectives.
Internal Controls - ANSWER A process effected by an entity's board of directors,
management, and other personnel designed to provide reasonable assurance regarding
the achievement of objectives.
Combination Products - ANSWER Defined in 21 CFR 3.2(e). The term combination
product includes: A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically,
chemically, or otherwise combined or mixed and produced as a single entity; Two or
more separate products packaged together in a single package or as a unit and
comprised of drug and device products, device and biological products, or biological
and drug products; A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended for use only with
an approved individually specified drug, device, or biological product where both are
required to achieve the intended use, indication, or effect and where upon approval of
the proposed product the labeling of the approved product would need to be changed,
e.g., to reflect a change in intended use, dosage form, strength, route of administration,
or significant change in dose; or Any investigational drug, device, or biological product
packaged separately that according to its proposed labeling is for use only with another
individually specified investigational drug, device, or biological product where both are
required to achieve the intended use, indication, or effect.
IDE stands for Investigational Device Exemptions, the regulations under 21 CFR 812. An
approved IDE simply means that the IRB (and FDA for significant risk devices) has
approved the sponsor's study application and all the requirements under 21 CFR 812
are met.
,Humanitarian Use Devices - ANSWER A medical device intended to benefit patients in
the treatment or diagnosis of a disease or condition that affects or is manifested in not
more than 8,000 individuals in the United States per year
FDA Site Inspections - ANSWER Pre-approval inspections; Routine inspections;
Compliance follow-up inspections; "For cause" inspections.
Assurance Certification - ANSWER Assurance of compliance indicating the the
institution will comply with the terms of the FWA.
Protocol - ANSWER Is a document outlining the design of a study, describing the
objectives, methodology and overall organization of the research to be carried out
forming a template and guide to the research process as a whole.
ICH - International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use; published Good Clinical Practice
Routine Costs - ANSWER Routine costs of a clinical trial are all items and services that
are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit
category, it is not statutorily excluded, and there is not a national non-coverage
decision) that are provided in either the experimental or the control arms of a clinical
trial except: The investigational item or service, itself unless otherwise covered outside
of the clinical trial; Items and services provided solely to satisfy data collection and
analysis needs and that are not used in the direct clinical management of the patient
(e.g., monthly CT scans for a condition usually requiring only a single scan); and Items
and services customarily provided by the research sponsors free-of-charge for any
enrollee in the trial.
Research Coding - ANSWER Z00.6 ICD-10 Diagnosis Code; Q0/Q1 Modifiers; Condition
Code 30 (hospital claims only - research setting); Clinicaltrials.gov registration number
or "NCT" number; Category B ID device HCPCS code if applicable; Condition Code 53
when the investigational device is furnished to the hospital at no cost (outpatient
hospital claims only)
HCPCS Modifier Q0 - ANSWER For the investigational clinical services provided in the
,clinical study
HCPCS Modifier Q1 - ANSWER To routine clinical services in the clinical study
USDA - ANSWER The Animal and Plant Health Inspection Service (APHIS) is a part of
the US Department of Agriculture (USDA) that enforces the AWA. Under the AWA,
organizations or individuals must register with the USDA as "research facilities" if they
plan to use a covered species in research and the research is federally-funded, or the
animals were purchased in commerce. Need to provide annual reports. Live/dead warm
blooded animals. Does not apply to field studies that don't have invasive procedures or
that don't harm or materially alter behavior. 12 hour inspection rule. Annual USDA
inspection. No retaliation for reporting. IACUC semi-annual inspection and program
review.
Office of Laboratory Animal Welfare (OLAW) - ANSWER Oversees the care and use of
research animals in any public or private organization, business, or agency (including
components of Federal, state, and local governments). Provides guidance and
interpretation of the PHS Policy, supports educational programs, and monitors
compliance with the Policy by Assured Institutions and PHS funding components for the
humane care and use of animals in PHS-supported research, testing and training to
enhance the quality of PHS-supported activities. Assurance and Annual Report. Live
vertebrate animals. Covers field studies if alter or influence. 24 hour inspection rule.
IACUC semi-annual inspections and program review.
USDA (highlights for exam) - ANSWER Animal Welfare Act; Live/dead warm blooded
animals; Does not apply to birds, rats, or mice. Does not apply to field studies that don't
have invasive procedures or that don't harm or materially alter behavior; 12 hour
inspection rule; Annual UDSA inspection; No retaliation for reporting; IACUC
semi-annual inspection & program review
OLAW (highlights for exam) - ANSWER Public Health Service Policy; Guide is
applicable; Assurance and Annual Report; Live vertebrate animals; Covers field studies
if alter or influence the activity of the study animals or other species found in the study
area; 24 hour inspection rule; IACUC semi-annual inspection & program review
4 Major Laws for Animal Research- ANSWER 1) US Government Principles for Utilization
and Care of Vertebrate Animals Used in Testing Research and Training; 2) Animal
, Welfare Act (AWA); 3) Public Health Service Policy on Humane Care and Use of
Laboratory Animals; 4) Guide for the Care and Use of Laboratory Animals ("The Guide)
Animal Welfare Act (AWA) - ANSWER Public Health Service Policy on Humane Care
and Use of Laboratory Animals Guide for the Care and Use of Laboratory Animals ("The
Guide")
Animal Research Laws have 3 Rs- ANSWER Refine- methods to minimize animal
suffering and help welfare; Reduce- Methods that minimize number of animals used in
experiments; Replace- methods that avoid or replace the use of animals in experiments
When HHS and FDA Protection of Human Subject Regulations Apply to same study -
ANSWER The IRB and Investigators must apply those specific regulations that offer the
greatest protections to participants.
Institutional Animal Care and Use Committee (IACUC) - ANSWER Is responsible for
oversight of the animal care and use program and its components. Its oversight
functions include an ongoing assessment of animal care and use. Membership shall
include at least 5 members: One veterinarian with training or experience in laboratory
animal science and medicine; One practicing scientist experienced in research with
animals; One member whose primary concerns are in a nonscientific area; One member
who is not affiliated with the institution other than as a member of the IACUC.
Semiannual Inspections. Drafts annual repot to be provided to OLAW via IO. Reports
serious or continuing non-compliance, serious deviation from the Guide, or suspension
of a protocol to OLAW via IO. Reports to USDA via IO any protocol suspension or
significant deficiency not corrected within prescribed period.
Animal Welfare Act (AWA) - ANSWER Signed into law on August 24, 1966. It is the only
Federal law in the United States that regulates the treatment of animals in research,
teaching, testing, exhibition, transport, and by dealers. The Act is enforced by USDA,
APHIS, Animal Care.
When does the AWA apply? - ANSWER Live or dead warm-blooded animals used or
intended for use in research, teaching, testing, experimentation, exhibition, or as pets.
Covers cats, dogs, nonhuman primates (monkey, etc.), guinea pigs, hamsters & rabbits,
and marine mammals. DOES NOT APPLY TO: rats of the genus Rattus or mice of the
genus Mus that are used for research. Birds bred in captivity for use in research are
