SOCRA CCRP ACTUAL EXAM
Complete Questions and Guide Answers
100% Verified Graded A+
1. Which countries are included in the ICH GCP?
Answer 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
Answer
3. According to ICH E6, an inspection is defined as
Answer 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.
,Answer 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
Answer C) Sponsor
6. 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.
7. 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).
8. Who is responsible for maintaining the close out report?
, Answer Sponsor
9. 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.
10. 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.
11. What FDA document must all investigators signed prior to participating in a drug
clinical trial?
Answer 1572
12. 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
Complete Questions and Guide Answers
100% Verified Graded A+
1. Which countries are included in the ICH GCP?
Answer 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
Answer
3. According to ICH E6, an inspection is defined as
Answer 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.
,Answer 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
Answer C) Sponsor
6. 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.
7. 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).
8. Who is responsible for maintaining the close out report?
, Answer Sponsor
9. 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.
10. 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.
11. What FDA document must all investigators signed prior to participating in a drug
clinical trial?
Answer 1572
12. 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
