CCRP Exam Questions with Correct Answers 100%
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Terms in this set (273)
How many days does a 5 working days
sponsor have to report an
emergency use of an IP to
the FDA?
How many members must 5
sit on an IRB?
How long must an IRB 3 years after completion of research
retain records per 21 CFR
56?
1. Risks to subjects are minimized
2. Risks are reasonable in relation to anticipated
benefits
3. Selection of subjects is equitable
What are the criteria for
4. Informed consent will be sought from subjects or
IRB approval of research?
LARs
(7)
5. Informed consent will be documented
6. There is adequate provision of monitoring
7. There is adequate provision to protect the privacy
of subjects
,How many days does an 90 days
IRB have to report a
change in registration
information due to a
change in chairperson or
contact?
How many days does an 30 days
IRB have to inform the
FDA that it is reviewing
different types of FDA
products?
How often must an IRB 3 years
renew it's registration?
1. Statement that the study involves research, purpose
and expected duration, description of experimental
procedures
2. Description of reasonably foreseeable risks
3. Benefits
What are the 8 basic
4. Disclosure of alternative procedures or courses of
elements of informed
treatment
consent per FDA
5. Confidentiality measures
guidelines?
6. Compensation and treatments available if injury
occurs
7. contact information
8. Participation is voluntary and subject may
discontinue at any time
What are the criteria for 1. No greater than minimal risk
involving children in 2. Assent from kid + consent from parent obtained
minimal risk research? (2)
What are the criteria for 1. Risks are justified by benefits
involving children in 2. Relation of anticipated benefit is at least as
greater than minimal risk favorable as that presented by alternative approaches
research with prospect of 3. Assent + consent
benefit? (3)
, 1. Risks are minor increase over minimal risk
What are the criteria for 2. Intervention presents experiences that are
involving children in reasonable commensurate with normal medical and
greater than minimal risk living situations
research with no direct 3. Intervention is likely to yield generalizable
benefit? (4) knowledge that is vital
4. Assent + consent
Sponsors must report 15 calendar days (21 CFR 312.32)
SAEs to the FDA within
how many days of
discovering the event?
Investigators must report Immediately (21 CFR 312.64)
SAEs to a sponsor within
how many days of
discovering the event?
1) Serious and unexpected suspected adverse
reactions
Sponsors must report 2) Findings from other studies that suggest a
what kind of serious significant risk in humans
events to the FDA within 15 3) Findings from animal or in-vitro testing that suggest
calendar days? (4) risks to humans
4) Increased rate of occurrence of serious suspected
adverse reactions
Sponsors must submit 10 working days (21 CFR 812.15)
Unanticipated Adverse
Device Effects to the FDA
within how many days?
Investigators must submit 10 working days (21 CFR 812.15)
Unanticipated Adverse
Device Effects to the FDA
within how many days?
When was the Nuremberg 1947
Code issued?
Verified
Save
Terms in this set (273)
How many days does a 5 working days
sponsor have to report an
emergency use of an IP to
the FDA?
How many members must 5
sit on an IRB?
How long must an IRB 3 years after completion of research
retain records per 21 CFR
56?
1. Risks to subjects are minimized
2. Risks are reasonable in relation to anticipated
benefits
3. Selection of subjects is equitable
What are the criteria for
4. Informed consent will be sought from subjects or
IRB approval of research?
LARs
(7)
5. Informed consent will be documented
6. There is adequate provision of monitoring
7. There is adequate provision to protect the privacy
of subjects
,How many days does an 90 days
IRB have to report a
change in registration
information due to a
change in chairperson or
contact?
How many days does an 30 days
IRB have to inform the
FDA that it is reviewing
different types of FDA
products?
How often must an IRB 3 years
renew it's registration?
1. Statement that the study involves research, purpose
and expected duration, description of experimental
procedures
2. Description of reasonably foreseeable risks
3. Benefits
What are the 8 basic
4. Disclosure of alternative procedures or courses of
elements of informed
treatment
consent per FDA
5. Confidentiality measures
guidelines?
6. Compensation and treatments available if injury
occurs
7. contact information
8. Participation is voluntary and subject may
discontinue at any time
What are the criteria for 1. No greater than minimal risk
involving children in 2. Assent from kid + consent from parent obtained
minimal risk research? (2)
What are the criteria for 1. Risks are justified by benefits
involving children in 2. Relation of anticipated benefit is at least as
greater than minimal risk favorable as that presented by alternative approaches
research with prospect of 3. Assent + consent
benefit? (3)
, 1. Risks are minor increase over minimal risk
What are the criteria for 2. Intervention presents experiences that are
involving children in reasonable commensurate with normal medical and
greater than minimal risk living situations
research with no direct 3. Intervention is likely to yield generalizable
benefit? (4) knowledge that is vital
4. Assent + consent
Sponsors must report 15 calendar days (21 CFR 312.32)
SAEs to the FDA within
how many days of
discovering the event?
Investigators must report Immediately (21 CFR 312.64)
SAEs to a sponsor within
how many days of
discovering the event?
1) Serious and unexpected suspected adverse
reactions
Sponsors must report 2) Findings from other studies that suggest a
what kind of serious significant risk in humans
events to the FDA within 15 3) Findings from animal or in-vitro testing that suggest
calendar days? (4) risks to humans
4) Increased rate of occurrence of serious suspected
adverse reactions
Sponsors must submit 10 working days (21 CFR 812.15)
Unanticipated Adverse
Device Effects to the FDA
within how many days?
Investigators must submit 10 working days (21 CFR 812.15)
Unanticipated Adverse
Device Effects to the FDA
within how many days?
When was the Nuremberg 1947
Code issued?
