SOCRA CCRP EXAM QUESTIONS
COMPLETE WITH CORRECT ANSWERS
\.Which countries are included in the ICH GCP? - ANSWERS-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 - ANSWERS-D) Reporting to IRB
\.According to ICH E6, an inspection is defined as: - ANSWERS-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. - ANSWERS-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 - ANSWERS-C) Sponsor
\.Records inspection - ANSWERS-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 - ANSWERS-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? - ANSWERS-
Sponsor
, \.Records identifying subjects. - ANSWERS-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 - ANSWERS-5 working days.
\.What FDA document must all investigators signed prior to
participating in a drug clinical trial? - ANSWERS-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 - ANSWERS-(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 - ANSWERS-5
working days.
COMPLETE WITH CORRECT ANSWERS
\.Which countries are included in the ICH GCP? - ANSWERS-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 - ANSWERS-D) Reporting to IRB
\.According to ICH E6, an inspection is defined as: - ANSWERS-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. - ANSWERS-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 - ANSWERS-C) Sponsor
\.Records inspection - ANSWERS-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 - ANSWERS-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? - ANSWERS-
Sponsor
, \.Records identifying subjects. - ANSWERS-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 - ANSWERS-5 working days.
\.What FDA document must all investigators signed prior to
participating in a drug clinical trial? - ANSWERS-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 - ANSWERS-(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 - ANSWERS-5
working days.
