Exam (elaborations)
SOCRA CCRP EXAM 2024 QUESTIONS AND CORRECT ANSWERS
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SOCRA CCRP EXAM 2024 QUESTIONS AND CORRECT ANSWERS
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Name: Score:97 Multiple choice questions
Term
During a study under an IND the investigator places the data on a laptop and the laptop is
stolen. The date it was not encrypted. The event is?
CRO, Contract research organization
protocol deviation and unanticipated event of risk to self or others
Qualified by experience.
Qualified by training.
3121 of 97
Term
What is not listed on the FDA 1571?
Name, address, phone number of the sponsor
A commitment not to start the clinical investigation until the IND is in effect.
Identification of the phase of the trial.
Approved informed consent document.2 of 97
Term
An investigator shall submit a final report to the sponsor and the reviewing IRB within.
A. A new drug or biological drug that is used in a clinical investigation.
-the product's delivery to the trial site
-the inventory at the site the use by each subject
-the return to the sponsor or alternative disposition of unused product
3 months after termination or completion of the investigation or the investigator's part of
the investigation.
As soon as possible but no later than 15 calendar days3 of 97 Term
An investigator shall submit a final report to the sponsor and the reviewing IRB within
a) To the IRB/IEC for review and approval/favorable opinion; (b) To the sponsor for
agreement and, if required;
(c) To the regulatory authority(ies).
3 months after termination or completion of the investigation or the investigator's part of
the investigation.
6 months after trial ends
5 working days after receipt of notice of the withdrawal of approval.4 of 97
Term
A drug's safety is determined by which of the following criteria?
A. The Food and Drug Administration's (FDA) review of source documentation at a clinical site
B. The absence of harmful side effects on the individuals exposed so far.
C. The dose at which no side effects are reported.
D. All of the above
D) All of the above
ASAP, no later than 7 calendar days, full report within 8 calendar days
D) Approved informed consent.
C. A. The dose at which no side effects are reported.5 of 97
Term
Payments to research subjects should be based on
Risk and discomfort
Time and inconvenience
The sponsor and the investigator
Direct access6 of 97 Term
True or False?
A source document is any document found that is associated with a clinical trial.
True
False7 of 97
Term
Responsibility for investigational product(s) accountability at the trial site(s) rests with the
the sponsor
protocol deviation.
cber
the investigator/institution.8 of 97
Term
Which countries are included in the ICH GCP?
European Union, Japan, United States, Canada and Switzerland
ASAP, no later than 15 calendar days
The IRB, sponsors and clinical investigators
Serious, unanticipated and possibly related to the drug9 of 97 Term
The sponsor should:
A sponsor, IRB, or investigator, or any other person acting on behalf of such a person
with respect to an investigation, shall permit authorized FDA employees, at reasonable
times and in a reasonable manner, to inspect and copy all records relating to an
investigation.
(a) The rights and well-being of human subjects are protected. (b) The reported trial data
are accurate, complete, and verifiable from source documents. (c) The conduct of the
trial is in compliance with the currently approved protocol/amendment(s), with GCP, and
with the applicable regulatory requirement(s).
An investigator shall permit authorized FDA employees to inspect and copy records that
identify subjects, upon notice that FDA has reason to suspect that adequate informed
consent was not obtained, or that reports required to be submitted by the investigator to
the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or
misleading.
(a) Ensure timely delivery of investigational product(s) to the investigator(s).
(b) Maintain records that document shipment, receipt, disposition, return, and
destruction of the investigational product(s)
(c) Maintain a system for retrieving investigational products and documenting this
retrieval (e.g., for deficient product recall, reclaim after trial completion, expired
product reclaim). (d) Maintain a system for the disposition of unused investigational
product(s) and for the documentation of this disposition10 of 97
Term
True or False?
Data reported on the CRF, that are derived from source documents, should be consistent with
the source documents or the discrepancies should be explained.
True
False11 of 97
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