ICH-GSP考试
1.When accounting for investigational drugs, which of the fllowing statements is true of investigatorrecord keeping?
A. Investigators do not need to account for investigational drug.
B. Amount of drug received at the rearch site needs to be tracked .
C. Amount of drug ud at the rearch site is not important to track.).
D. Amount of drug on hand includes drug that is not ud in the study.
2.То document that the rearch participant has voluntarily agreed to participate in the study, therearch participant must:
A. Pass a test of comprehension.
B. Meet with the institution's Institutional Review Board (IRB).
C. Sign and date the Informed Connt Form.
D. All of the above.
4.An ongoing clinical protocol at your site includes weekly blood draws to asss an exploratorysns endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they areconsidering dropping out. Therefore, a protocol amendment is being prepared to remove the weeklyblood draw. This change can be implemented:
A. Immediately, as it iS not a safety asssment.
B. Once the protocol is finalized and submitted to the FDA.
С. Once the protocol and connt form updates are approved by the
IRB.
D. As soon as the study sponsor advis that their decision iS final to remove the blood draws.
4.Which of the following statements is fal regarding errors in the informed connt process?
A. Errors are considered protocol violations and must be reported to the relevant IR
B.B. Errors are very uncommon and always result in suspension of the study.
B. Errors must be dealt with openly and honestly.
C. Once errors are identified, a description must be provided of the action taken to correct theerror and prevent it from occurring again.
5 The main reason site monitoring visits are conducted is to:
A.Socialize with the rearch team members.
В. Ensure compliance with quality standards.
с. Punish the rearch staff for making mistakes.
D. All of the above.
6.A protocol violation is:
A. An omission (i.e., failure to do something required in the protocol)
B. An addition (i.e., any action that is not required in the protocol).
C. Achange in any procedure described in the protocol
D. All of the above.
7 .Investigators/Rearchers must ensure that subjects identified
for participation in a study are notlected becau of their.
A. Insurability.
B. Social status.
C. Amount of income.
D. All of the above.
8.If a study participant indicates that he plans to move from one residence to another during studys09 participation, site staff should.
A. Wait for the participant to move and hope to get the new contact information during a laterstudy visit.
В. Record the new contact information in the participant's file and advi the site's rearchteam.
С. Keep nding notifications to the participant's former address after the move date.
D. Do nothing.
9.After a drug has been approved for marketing, FDA may ask the company lling the drug tocontinue to examine the safety Of the drug when ud long term. The studies are usuallyconsidered studies.
A.Pha 1 В. Pha 2 С. Pha 3 D. Pha 4
10 According to GCP and CFR regulations, documentation of informed connt include which of thefollow?
A.The IRB must approve the connt form.
B.The participant or the participant's legally authorized
reprentative must sign the currentversion of the IRB approved
connt form.
C. Acopy must be given to the person that signs it.
D. All of the above.
11 What can be done to try to reduce the number of protocol violations?
A. Provide thorough protocol trainings and refreshers.
B. Notify all staff members of protocol amendments.
C. Update the Operations Manual to reflect the changes to the protocol.
D. All of the above.
12 A participant misd veral study visits and the rearch site staff becomes aware of a 308 participant's death arching through public records. What is the most appropriate next cour of action?
A. Report this as a rious adver event (SAE).
B. Report this as an adver event (AE).
C. No action iS required.
D. Contact the Study Physician for instructions on next steps.
13 Study monitors are
A.Familiar with the product under investigation in the study.
B.Appropriately trained and have qualific ations to monitor clinical
studies.
C.Not required to have any specific knowledge of the trial or the
investigational product.ว
D.AIll of the above.
14 Esntial documents defined in GCP guidelines fulfill all of the fllowing purpos, including:
A.Assist in the documentation management for a rearch trial.
B.Provide quality assurance auditors and regulatory inspectors with
an audit trail for asssingthe validity in the conduct of a study.
C.Verify compliance to GCP, sponsor, and regulatory requirements.
15 Which of the following practices ensure the confidentiality of rearch participants?
A.Properly dispo 0f all paper documents containing identifiers
(SSN, address, DOB, etc.)..
B.Require passwords to access computerized records.
C. U the participant's SSN instead of the participant's full name.
D. Store paper records in a cure place (cure room, locked cabinet, safe, etc.).
16 If a protocol change is needed to eliminate an apparent immediate hazard to study participants, thisshould only be implemented after.
A. Notifying the FDA via a protocol amendment.
B. Notifying the IRB.
