SOCRA CCRP EXAM 2025 – 2026 UPDATE .
Which countries are included in the ICH GCP? ANS - 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 ANS -
According to ICH E6, an inspection is defined as: ANS - 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. ANS -
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 ANS - C) Sponsor
Records inspection ANS - 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 ANS - 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? ANS - Sponsor
, Records identifying subjects. ANS - 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 ANS - 5 working days.
What FDA document must all investigators signed prior to participating in a drug clinical trial?
ANS - 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 ANS - (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 ANS - 5 working days.
Sponsor must report to FDA and all investigators in an IND safety report of potential serious
risks no later than ANS - As soon as possible but no later than 15 calendar days
Device: Withdrawal of IRB approval ANS - 5 working days
The FDA form 483 is used for ANS - Inspectional Observations
What is the federal department responsible for helping people of Canada maintain and
improve their health? ANS - Health Canada
.
Who monitors the progress of all clinical trial investigations being conducted under its IND?
ANS - The Sponsor
.
Which countries are included in the ICH GCP? ANS - 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 ANS -
According to ICH E6, an inspection is defined as: ANS - 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. ANS -
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 ANS - C) Sponsor
Records inspection ANS - 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 ANS - 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? ANS - Sponsor
, Records identifying subjects. ANS - 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 ANS - 5 working days.
What FDA document must all investigators signed prior to participating in a drug clinical trial?
ANS - 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 ANS - (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 ANS - 5 working days.
Sponsor must report to FDA and all investigators in an IND safety report of potential serious
risks no later than ANS - As soon as possible but no later than 15 calendar days
Device: Withdrawal of IRB approval ANS - 5 working days
The FDA form 483 is used for ANS - Inspectional Observations
What is the federal department responsible for helping people of Canada maintain and
improve their health? ANS - Health Canada
.
Who monitors the progress of all clinical trial investigations being conducted under its IND?
ANS - The Sponsor
.
