SOCRA CCRP FINAL EXAM WITH DETAILED QUESTIONS
AND VERIFIED CORRECT ANSWERS/ ALREADY GRADED
A++
Contract Research Organization -ANSWER A person or an organization
(commercial, academic, or other) contracted by the sponsor to
perform one or more of a sponsor's trial-related duties and functions.
When a short form is used for informed consent the witness must sign the
short form or the summary? -ANSWER False-they must sign both
What is FDA form 3454 -ANSWER Certification Financial Interests and
Arrangements of Clinical Investigators
What are the three main basic ethical principles of the Belmont Report? -
ANSWER Respect for persons.
Beneficence.
Justice.
Phase III -ANSWER Study Participants: 300 to 3,000 volunteers who have
the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Phase I -ANSWER 20 to 100 healthy volunteers or people with the
disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Phase II -ANSWER Study Participants: Up to several hundred people with
the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
,The main concept of 21 CFR 50 is -ANSWER protection of human subjects
21 CFR 50 part D -ANSWER protection of childern
A____________ can be any unfavorable and unintended sign) including an
abnormal laboratory finding), symptom, or disease temporally associated
with the use of a medicinal (investigational) product, whether or not related
to the medicinal (investigational) product. -ANSWER adverse event
The FDA form 483 is used for _______ -ANSWER Inspectional
oberservation
The international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve the participation of
human subjects is known as -ANSWER GCP
A(n) _________ is an investigational or marketed product, or placebo, used
as a reference in a clinical trial. -ANSWER comparator
What is 21 CFR 50.23 Subpart B? -ANSWER the exception to the general
requirements
This form is used for the voluntary reporting of adverse events and product
problems -ANSWER 3500
is permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial -ANSWER direct
access
21 cfr part b -ANSWER ICF
Belmont Report (1979) -ANSWER respect for persons, beneficence, justice
significant risk device -ANSWER s a study of a device that presents a
potential for serious risk to the health, safety, or welfare of a subject and (1)
is intended as an implant; or (2) is used in supporting or sustaining human
life; or (3) is of substantial importance in diagnosing, curing, mitigating
,A ________is a printed, optical or electronic document designed to record
all of the protocol required information to be reported to the sponsor on
each trial subject -ANSWER crf
sae form -ANSWER 3500a
The sponsor shall notify the FDA by telephone or fax any unexpected fatal
or life-threatening experience associated with the use of the drug as soon
as possible but no later than _____ after the sponsor's initial receipt of the
information -ANSWER 7 days
Unexpected serious suspected adverse reactions and observations from
animal studies suggesting significant risk to human subjects must be
reported to FDA as soon as possible but no later than within __ calendar
days following the sponsor's initial receipt of the information. -ANSWER 15
days
the sponsor must notify FDA of any UNEXPECTED FATAL LIFE
THREATENING SUSPECTED adverse reactions ASAP but no later than
__calendar days following the sponsor's initial receipt of the information -
ANSWER 7 days
Follow-up IND Safety Report. Such report should be submitted without
delay, as soon as the information is available but no later than __calendar
days after the sponsor receives the information. -ANSWER 15 days
What date should an investigator write when he failed to sign the consent
form on the date of consent? -ANSWER date of investigators signature
for MEDICAL DEVICE trials the P.I. should submit to the sponosr & IRB a
report of any unanticapted adverse asap but no later than___ -ANSWER
10 days
assent -ANSWER means a child's affirmative agreement to participate in a
clinical investigation. consent from 1 or both parents or LAR is required.
IRB exemptions can be made If immediate use of the test article is, in the
investigator's opinion, required to preserve the life of the subject, and time
is not sufficient to obtain the independent determination use of the test
article, must be submitted to the IRB and FDA in -ANSWER 5 days
, control group design -ANSWER eliminates bias
double bllinded -ANSWER neither the subjects nor the experimenters know
which subjects are in the test and control groups
randomized double blilnded -ANSWER placebo-controlled trial of a medical
treatment, some of the participants are given the treatment, others are
given fake treatment (placebo), and neither the researchers nor the
participants know which is which until the study ends
single blinded -ANSWER only the participant does not know whether they
are part of the treatment or control group,
cross over design -ANSWER is a longitudinal study in which subjects
receive a sequence of different treatments (or exposures).
how long should essential clinical trial records be retained at site? -
ANSWER 2 yrs after FDA approval or 2 years after study ended
The records required by this policy shall be retained for at least _____and
records relating to research
which is conducted shall be retained for at least ___ years after completion
of the research. -ANSWER 3 years
changes in protocol -ANSWER A sponsor shall submit a protocol
amendment describing any change in a Phase 1 protocol that significantly
affects the safety of subjects or any change in a Phase 2 or 3 protocol that
significantly affects the safety of subjects, the scope of the investigation, or
the scientific quality of the study.
class I -ANSWER General controls bandages, gloves, tongue depressors
Class II -ANSWER general control+special controls (x-ray machines,
monitors)
Class III -ANSWER general controls+ premarket approval (pacemaker,
diagnostic test, silicone gel breast implant)
AND VERIFIED CORRECT ANSWERS/ ALREADY GRADED
A++
Contract Research Organization -ANSWER A person or an organization
(commercial, academic, or other) contracted by the sponsor to
perform one or more of a sponsor's trial-related duties and functions.
When a short form is used for informed consent the witness must sign the
short form or the summary? -ANSWER False-they must sign both
What is FDA form 3454 -ANSWER Certification Financial Interests and
Arrangements of Clinical Investigators
What are the three main basic ethical principles of the Belmont Report? -
ANSWER Respect for persons.
Beneficence.
Justice.
Phase III -ANSWER Study Participants: 300 to 3,000 volunteers who have
the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Phase I -ANSWER 20 to 100 healthy volunteers or people with the
disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Phase II -ANSWER Study Participants: Up to several hundred people with
the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
,The main concept of 21 CFR 50 is -ANSWER protection of human subjects
21 CFR 50 part D -ANSWER protection of childern
A____________ can be any unfavorable and unintended sign) including an
abnormal laboratory finding), symptom, or disease temporally associated
with the use of a medicinal (investigational) product, whether or not related
to the medicinal (investigational) product. -ANSWER adverse event
The FDA form 483 is used for _______ -ANSWER Inspectional
oberservation
The international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve the participation of
human subjects is known as -ANSWER GCP
A(n) _________ is an investigational or marketed product, or placebo, used
as a reference in a clinical trial. -ANSWER comparator
What is 21 CFR 50.23 Subpart B? -ANSWER the exception to the general
requirements
This form is used for the voluntary reporting of adverse events and product
problems -ANSWER 3500
is permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial -ANSWER direct
access
21 cfr part b -ANSWER ICF
Belmont Report (1979) -ANSWER respect for persons, beneficence, justice
significant risk device -ANSWER s a study of a device that presents a
potential for serious risk to the health, safety, or welfare of a subject and (1)
is intended as an implant; or (2) is used in supporting or sustaining human
life; or (3) is of substantial importance in diagnosing, curing, mitigating
,A ________is a printed, optical or electronic document designed to record
all of the protocol required information to be reported to the sponsor on
each trial subject -ANSWER crf
sae form -ANSWER 3500a
The sponsor shall notify the FDA by telephone or fax any unexpected fatal
or life-threatening experience associated with the use of the drug as soon
as possible but no later than _____ after the sponsor's initial receipt of the
information -ANSWER 7 days
Unexpected serious suspected adverse reactions and observations from
animal studies suggesting significant risk to human subjects must be
reported to FDA as soon as possible but no later than within __ calendar
days following the sponsor's initial receipt of the information. -ANSWER 15
days
the sponsor must notify FDA of any UNEXPECTED FATAL LIFE
THREATENING SUSPECTED adverse reactions ASAP but no later than
__calendar days following the sponsor's initial receipt of the information -
ANSWER 7 days
Follow-up IND Safety Report. Such report should be submitted without
delay, as soon as the information is available but no later than __calendar
days after the sponsor receives the information. -ANSWER 15 days
What date should an investigator write when he failed to sign the consent
form on the date of consent? -ANSWER date of investigators signature
for MEDICAL DEVICE trials the P.I. should submit to the sponosr & IRB a
report of any unanticapted adverse asap but no later than___ -ANSWER
10 days
assent -ANSWER means a child's affirmative agreement to participate in a
clinical investigation. consent from 1 or both parents or LAR is required.
IRB exemptions can be made If immediate use of the test article is, in the
investigator's opinion, required to preserve the life of the subject, and time
is not sufficient to obtain the independent determination use of the test
article, must be submitted to the IRB and FDA in -ANSWER 5 days
, control group design -ANSWER eliminates bias
double bllinded -ANSWER neither the subjects nor the experimenters know
which subjects are in the test and control groups
randomized double blilnded -ANSWER placebo-controlled trial of a medical
treatment, some of the participants are given the treatment, others are
given fake treatment (placebo), and neither the researchers nor the
participants know which is which until the study ends
single blinded -ANSWER only the participant does not know whether they
are part of the treatment or control group,
cross over design -ANSWER is a longitudinal study in which subjects
receive a sequence of different treatments (or exposures).
how long should essential clinical trial records be retained at site? -
ANSWER 2 yrs after FDA approval or 2 years after study ended
The records required by this policy shall be retained for at least _____and
records relating to research
which is conducted shall be retained for at least ___ years after completion
of the research. -ANSWER 3 years
changes in protocol -ANSWER A sponsor shall submit a protocol
amendment describing any change in a Phase 1 protocol that significantly
affects the safety of subjects or any change in a Phase 2 or 3 protocol that
significantly affects the safety of subjects, the scope of the investigation, or
the scientific quality of the study.
class I -ANSWER General controls bandages, gloves, tongue depressors
Class II -ANSWER general control+special controls (x-ray machines,
monitors)
Class III -ANSWER general controls+ premarket approval (pacemaker,
diagnostic test, silicone gel breast implant)
