SOCRA CCRP EXAM 2026/2027 QUESTIONS AND
100% VERIFIED ANSWERS
1. Which countries are included in the ICH GCP?: European Union, Japan, United States, Canada and
Switzerland
2. What is the monitor not responsible for?
A) Patient information
B) Sponsor SOP
C) Protocol/ICF
D) Reporting to IRB:
3. According to ICH E6, an inspection is defined as:: An oflcial review of documents, facilities, records, and
any other resources related to a clinical trial.
4. An investigator shall submit a final report to the sponsor and the reviewing IRB within.: 3
months after termination or completion of the investigation or the investigator's part of the investigation.
5. 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: C) Sponsor
6. Records inspection: 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.
7. Entry and Inspection: 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, pacḳed, installed, used, or implanted or where records
of results from use of devices are ḳept).
8. Who is responsible for maintaining the close out report?: Sponsor
,9. Records identifying subjects.: 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.
, 10. If an investigator uses a device without obtaining informed consent, the in-
vestigator shall report such use to the sponsor and the reviewing IRB within: 5 worḳing days.
11. What FDA document must all investigators signed prior to participating in a drug
clinical trial?: 1572
12. The contents of a protocol should generally contain:
(A) Trial objectives and purpose
(B) Assessment of efficacy
(C) Data handling and recordḳeeping
(D) All of the above: (D) ALl of the above
13. An investigator shall notify the sponsor and the reviewing IRB of any devi- ation from
the investigational plan to protect the life or physical well-being of a subject in an
emergency no later than: 5 worḳing days.
14. Sponsor must report to FDA and all investigators in an IND safety report of potential
serious risḳs no later than: As soon as possible but no later than 15 calendar days
15. Device: Withdrawal of IRB approval: 5 worḳing days
16. The FDA form 483 is used for: Inspectional Observations
17. What is the federal department responsible for helping people of Canada maintain
and improve their health?: Health Canada
18. .
Who monitors the progress of all clinical trial investigations being conducted under its
IND?: The Sponsor
19. .
A(n) is a printed, optical or electronic document designed to record
all of the protocol required information to be reported to the sponsor on each trial
subject.: Case Report Form- CRF
20. is permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.: Direct Access
21. The form is used for investigational new drugs (or IND).: 1571
22. Under 21CFR312, this form is the statement of the investigator of a clinical trial.:
100% VERIFIED ANSWERS
1. Which countries are included in the ICH GCP?: European Union, Japan, United States, Canada and
Switzerland
2. What is the monitor not responsible for?
A) Patient information
B) Sponsor SOP
C) Protocol/ICF
D) Reporting to IRB:
3. According to ICH E6, an inspection is defined as:: An oflcial review of documents, facilities, records, and
any other resources related to a clinical trial.
4. An investigator shall submit a final report to the sponsor and the reviewing IRB within.: 3
months after termination or completion of the investigation or the investigator's part of the investigation.
5. 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: C) Sponsor
6. Records inspection: 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.
7. Entry and Inspection: 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, pacḳed, installed, used, or implanted or where records
of results from use of devices are ḳept).
8. Who is responsible for maintaining the close out report?: Sponsor
,9. Records identifying subjects.: 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.
, 10. If an investigator uses a device without obtaining informed consent, the in-
vestigator shall report such use to the sponsor and the reviewing IRB within: 5 worḳing days.
11. What FDA document must all investigators signed prior to participating in a drug
clinical trial?: 1572
12. The contents of a protocol should generally contain:
(A) Trial objectives and purpose
(B) Assessment of efficacy
(C) Data handling and recordḳeeping
(D) All of the above: (D) ALl of the above
13. An investigator shall notify the sponsor and the reviewing IRB of any devi- ation from
the investigational plan to protect the life or physical well-being of a subject in an
emergency no later than: 5 worḳing days.
14. Sponsor must report to FDA and all investigators in an IND safety report of potential
serious risḳs no later than: As soon as possible but no later than 15 calendar days
15. Device: Withdrawal of IRB approval: 5 worḳing days
16. The FDA form 483 is used for: Inspectional Observations
17. What is the federal department responsible for helping people of Canada maintain
and improve their health?: Health Canada
18. .
Who monitors the progress of all clinical trial investigations being conducted under its
IND?: The Sponsor
19. .
A(n) is a printed, optical or electronic document designed to record
all of the protocol required information to be reported to the sponsor on each trial
subject.: Case Report Form- CRF
20. is permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.: Direct Access
21. The form is used for investigational new drugs (or IND).: 1571
22. Under 21CFR312, this form is the statement of the investigator of a clinical trial.:
