ICH GCP Guidelines Quiz: Test!
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This quiz was developed to determine the basic knowledge of ICH GCP Guidelines. You will have 25 minutes to answer 20 randomly selected, shuffled questions. You may not refer to any material or consult with another individual while completing this assessment; doing so will render the assessment and your application invalid.
- 1.Neither the investigator nor the trial staff should ________ or unduly influence a subject to participate or to continue to participate in a trial.
- A.
Convince
- B.
Coerce
- C.
Compel
- D.
Change the opinion
- 2.Who is responsible for the conduct of the clinical trial at a trial site?
- A.
Clinical Research Coordinator
- B.
Monitor
- C.
Investigator
- D.
Sponsor
- 3.Which is NOT one of the purposes of trial monitoring?
- A.
To verity that the rights and well-being of human subjects are protected.
- B.
To verify that the reported trial data are accurate, complete, and verifiable from source documents.
- C.
To verify that all financial obligations between the Sponsor and the Investigator are fulfilled.
- D.
To verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
- 4.The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
- A.
True
- B.
False
- 5.Clinical trials should be conducted in accordance with the ethical principles that are consistent with GCP and the applicable regulatory requirement(s), and that have their origin in the Declaration of ___________.
- A.
Clinical Research Regulations
- B.
Independence
- C.
Geneva Conference
- D.
Helsinki
- 6.Freely given informed consent should be obtained from every subject prior to clinical participation after an investigational product is taken.
- A.
True
- B.
False
- 7.Investigational projects should be manufactured, handled, and stored in accordance with applicable _____.
- A.
GCP
- B.
GMP
- C.
ACRP
- D.
IRB
- 8.The IRB/IEC should consider the qualifications of the investigator and the monitor for the purposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
- A.
True
- B.
False
- 9.The IRB/IEC should review a proposed clinical trial within a reasonable time anddocument its views in writing, clearly identifying the trial, the documents reviewed,and the dates for the following: (A) Approval/favorable opinion; (B) Modifications required prior to its approval/favorable opinion; (C) Disapproval/negative opinion; and (D) Termination/suspension of any prior approval/favorable opinion.
- A.
All of the above
- B.
A only
- C.
A, B, and C
- D.
A and C
- 10.The ICH GCP guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the Association of Advanced Neurology.
- A.
True
- B.
False
- 11.An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that must have a causal relationship with this treatment.
- A.
True
- B.
False
- 12.Please fill in the blank. _______ subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
- 13.Which documents should the IRB/IEC obtain and review prior to approving a clinical trial? (select all that apply)
- A.
Trial protocol(s)/amendments
- B.
Written ICFs
- C.
Subject recruitment procedures
- D.
Monitoring confirmation letters
- E.
Investigator's Brochure
- 14.A trial should be conducted in compliance with a protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
- A.
True
- B.
False
- 15.The sponsor should appoint individuals, who are independent of the clinical trial/data collection system(s), to conduct audits.
- A.
True
- B.
False
- 16.If a trial is terminated prematurely or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s).
- A.
True
- B.
False
- 17.Data reported on the ______, which are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.
- A.
Statistical Analysis Plan (SAP)
- B.
Case Report Form (CRF)
- C.
Protocol
- 18.Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial related records only if a comprehensive list of such is provided at least 15 business days prior to date of review/access.
- A.
True
- B.
False
- 19.Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR): Any untoward medical occurrence that at any dose: (A) Results in death (B) Is life-threatening (C) Requires inpatient hospitalization or prolongation of existing hospitalization (D) Results in persistent or significant disability/incapacity (E) Is a congenital anomaly/birth defect.
- A.
A and C
- B.
A, C, and E
- C.
B, C, D and E
- D.
All of the above
- 20.The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
- A.
True
- B.
False
- 21.Clinical trials should be scientifically sound, and described in clear, detailed protocol.
- A.
True
- B.
False
- 22.Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- A.
True
- B.
False
- 23.The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once every ______ year(s).
- A.
One
- B.
Five
- C.
Three
- D.
Ten
- 24.The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: [SELECT ALL THAT APPLY]
- A.
At least 100 members
- B.
At least one member whose primary area of interest is in a nonscientific area
- C.
At least one member who is independent of the institution/trial site.
- 25.An IRB/IEC may not, under any circumstances, invite nonmembers with expertise in special areas for assistance.
- A.
True
- B.
False
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