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SOCRA CCRP EXAM With 100% Correct And Verified Answers
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SOCRA CCRP EXAM With 100% Correct And Verified Answers
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SOCRA CCRP EXAM With 100% CorrectAnd Verified Answers
A patient received an initial dose and had no initial
reaction. The protocol says the patient needs to
increase it by 20%. The initial dose was
370mg^3/m; what is the next treatment? - Correct
Answer-444mg^3/m
Which countries are included in the ICH GCP? -
Correct Answer-European Union, Japan, United
States, Canada and Switzerland
What is the monitor not responsible for?
A) Patient information
B) Sponsor SOP
C) Protocol/ICF
D) Reporting to IRB - Correct Answer-
According to ICH E6, an inspection is defined as: -
Correct Answer-An official review of documents,
facilities, records, and any other resources related
to a clinical trial.
An investigator shall submit a final report to the
sponsor and the reviewing IRB within. - Correct
Answer-3 months after termination or completion
of the investigation or the investigator's part of the
investigation.
The responsibility for ensuring that the
investigator understands a clinical trial lies with
which individual/or organization?
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,A) FDA
B) IRB
C) Sponsor
D) Coordinator - Correct Answer-C) Sponsor
Records inspection - Correct Answer-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.
Entry and Inspection - Correct Answer-A sponsor or
an investigator who has authority to grant access
shall permit authorized FDA employees, at
reasonable times and in a reasonable manner, to
enter and inspect any establishment where devices
are held (including any establishment where
devices are manufactured, processed, packed,
installed, used, or implanted or where records of
results from use of devices are kept).
Who is responsible for maintaining the close out
report? - Correct Answer-Sponsor
Records identifying subjects. - Correct Answer-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
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, submitted or are incomplete, inaccurate, false, or
misleading.
If an investigator uses a device without obtaining
informed consent, the investigator shall report
such use to the sponsor and the reviewing IRB
within - Correct Answer-5 working days.
What FDA document must all investigators signed
prior to participating in a drug clinical trial? -
Correct Answer-1572
The contents of a protocol should generally
contain:
(A) Trial objectives and purpose
(B) Assessment of efficacy
(C) Data handling and recordkeeping
(D) All of the above - Correct Answer-(D) ALl of the
above
An investigator shall notify the sponsor and the
reviewing IRB of any deviation from the
investigational plan to protect the life or physical
well-being of a subject in an emergency no later
than - Correct Answer-5 working days.
Sponsor must report to FDA and all investigators in
an IND safety report of potential serious risks no
later than - Correct Answer-As soon as possible but
no later than 15 calendar days
Device: Withdrawal of IRB approval - Correct
Answer-5 working days
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