SOCRA CCRP FINAL 2024 EXAM COMPREHENSIVE
QUESTIONS 300 QUESTIONS WITH DETAILED VERIFIED
ANSWERS (100% CORRECT)
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) B
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?
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 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.
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