Exam (elaborations)
SOCRA CCRP EXAM 2024/2025
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SOCRA CCRP EXAM 2024/2025
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SOCRA CCRP EXAM 2024/2025A 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? - Answer ✔✔444mg^3/m
Which countries are included in the ICH GCP? - 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 - Answer ✔✔
According to ICH E6, an inspection is defined as: - 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. - 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 - Answer ✔✔C) Sponsor
Records inspection - 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 - 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? - Answer
✔✔Sponsor
Records identifying subjects. - 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 - Answer ✔✔5 working days.
What FDA document must all investigators signed prior to participating
in a drug clinical trial? - 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 - 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 - Answer ✔✔5
working days.
Sponsor must report to FDA and all investigators in an IND safety report
of potential serious risks no later than - Answer ✔✔As soon as possible
but no later than 15 calendar days
Device: Withdrawal of IRB approval - Answer ✔✔5 working days
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