SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE|2024
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Course
SOCRA CCRP
Institution
SOCRA CCRP
SOCRA CCRP EXAM
ACTUAL EXAM 200
QUESTIONS AND
CORRECT DETAILED
ANSWERS WITH
RATIONALES
|AGRADE|2024
ICFANSWERAn informed consent form (ICF) is
used to ensure everyone involved in clinical research is a
willing participant, with full knowledge of the potential
risks and benefits to the ext...
SOCRA CCRP EXAM
ACTUAL EXAM 200
QUESTIONS AND
CORRECT DETAILED
ANSWERS WITH
RATIONALES
|AGRADE|2024
ICF✔✔✔ANSWER➖An informed consent form (ICF) is
used to ensure everyone involved in clinical research is a
willing participant, with full knowledge of the potential
risks and benefits to the extent that this is possible.
ICH✔✔✔ANSWER➖This International Conference on
Harmonization (ICH) document makes recommendations
,on information that should be included in a core clinical
study report of an individual study of any therapeutic,
prophylactic, or diagnostic agent conducted in human
subjects.
IRB✔✔✔ANSWER➖Institutional Review Board (IRB)?
Under FDA regulations, an IRB is an appropriately
constituted group that has been formally designated to
review and monitor biomedical research involving human
subjects.
IRT✔✔✔ANSWER➖IRT stands for Interactive
Response Technology; it uses the web or phone to allow
users to interact with a system. A Clinical IRT is a web-
based tool for managing subjects and inventory during a
clinical trial/study.
ADR✔✔✔ANSWER➖adverse drug reaction, is
unintended/unwanted pharmacologic effects that occur
due to medication.
AE✔✔✔ANSWER➖adverse event, is any untoward or
unfavorable medical occurrence in a human. subject,
including any abnormal sign (for example, abnormal
,physical exam or. laboratory finding), symptom, or
disease, temporally associated with the subject's.
SAE✔✔✔ANSWER➖Serious Adverse Event: An
adverse event that results in any of the following:
Death
Life-threatening situation
Inpatient hospitalization
Prolongation of existing hospitalization
Persistent or significant disability/incapacity
Congenital anomaly/birth defect
How many days does a sponsor have to report an
emergency use of an IP to the FDA?✔✔
ANSWER➖5 working days
How long must an IRB retain records per 21 CFR
56?✔✔ANSWER➖3 years after completion of research
What are the criteria for IRB approval of
research?✔✔ANSWER➖1. Risks to subjects are
minimized
, 2. Risks are reasonable in relation to anticipated benefits
3. Selection of subjects is equitable
4. Informed consent will be sought from subjects or LARs
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 IRB have to report a change in
registration information due to a change in chairperson or
contact?✔✔ANSWER➖90 days
How many days does an IRB have to inform the FDA that
it is reviewing different types of FDA
products?✔✔ANSWER➖30 days
How often must an IRB renew it's
registration?✔✔ANSWER➖3 years
What are the basic elements of informed consent per FDA
guidelines?✔✔ANSWER➖1. Statement that the study
involves research, purpose and expected duration,
description of experimental procedures
2. Description of reasonably foreseeable risks
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