SOCRA CCRP ACTUAL exam questions and CORRECT answers|100%
GUARANTEED PASS graded A+| Updated, Exams of Law
Which countries are included in the ICH GCP? - ANSWEREuropean 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: - ANSWERAn 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. - ANSWER3 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 - ANSWERC) Sponsor
Records inspection - ANSWERA 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 - ANSWERA 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? - ANSWERSponsor
Records identifying subjects. - ANSWERAn 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
- ANSWER5 working days.
What FDA document must all investigators signed prior to participating in a
drug clinical trial? - ANSWER1572
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 - ANSWER5 working days.
Sponsor must report to FDA and all investigators in an IND safety report of
potential serious risks no later than - ANSWERAs soon as possible but no later
than 15 calendar days
Device: Withdrawal of IRB approval - ANSWER5 working days
The FDA form 483 is used for - ANSWERInspectional Observations
What is the federal department responsible for helping people of Canada
maintain and improve their health? - ANSWERHealth Canada
GUARANTEED PASS graded A+| Updated, Exams of Law
Which countries are included in the ICH GCP? - ANSWEREuropean 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: - ANSWERAn 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. - ANSWER3 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 - ANSWERC) Sponsor
Records inspection - ANSWERA 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 - ANSWERA 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? - ANSWERSponsor
Records identifying subjects. - ANSWERAn 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
- ANSWER5 working days.
What FDA document must all investigators signed prior to participating in a
drug clinical trial? - ANSWER1572
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 - ANSWER5 working days.
Sponsor must report to FDA and all investigators in an IND safety report of
potential serious risks no later than - ANSWERAs soon as possible but no later
than 15 calendar days
Device: Withdrawal of IRB approval - ANSWER5 working days
The FDA form 483 is used for - ANSWERInspectional Observations
What is the federal department responsible for helping people of Canada
maintain and improve their health? - ANSWERHealth Canada
