Good Clinical Practice (GCP) Training and Finding

1.According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how frequently?

A. At least once after AE/SAE is reported B. At least once per year C. At least once in two years D. After recruitment is completed

2.According to ICH GCP addendum in monitoring report which of the following statement is correct:

A. Reports of on-site monitoring should be provided to the sponsor B. Reports of centralized monitoring should be provided to the sponsor C. Reports of on-site and/or centralized monitoring should be provided to the sponsor D. Reports of monitoring should be provided to the sponsor immediately after site visit

3.According to ICH GCP how training should be documented?

A. CVs B. Training Records C. Certificate D. There is no specification

4. Which of the following is NOT an ICH GCP requirement for clinical trial sites?

A. Adequately trained staff B. Adequate facilities C. Experienced staff D. Study co-ordinator

5.According to ICH GCP “The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias” is definition of XXXX.

A. Blinding B. Randomization C. Masking D. Direct Access

6.According to Principles of ICH GCP, What should be obtained from every subject prior to clinical trial participation?

A. Subject’s medical records B. Freely given informed consent C. Subject’s identity card D. No objection certificate from subject’s primary physician

7.According to Principles of ICH GCP Each individual involved in conducting a trial should be qualified by XXXX to perform his or her respective task(s).

A. education and training B. training and experience C. education, training and experience D. education, training and relevant experience

8.Section 6 of ICH GCP states the protocol should generally include stopping rules for individual subjects, parts of trials and entire trial. What other term does it specify in addition to Stopping Rule?

A. Interim Analyses B. Endpoints C. Termination Criteria D. Discontinuation Criteria

9.According to ICH GCP in obtaining and documenting informed consent, the investigator should comply with/adhere to:

A. Applicable regulatory requirement and Declaration of Helsinki B. Applicable regulatory requirement, GCP and Declaration of Helsinki C. Applicable regulatory requirement, GCP and IRB/IEC D. GCP, IRB/IEC and Declaration of Helsinki

10.Before the clinical phase of the trial commences where should the sample of labels attached to investigational product(s) be filed?

A. The Sponsor file only B. The investigator file only C. Both the sponsor and investigator files D. Both the sponsor and investigator files and third party (if applicable)

11.According to ICH GCP which of the following is not part of the sponsor’s responsibility for determining for Investigational product:

A. Storage temperatures B. Storage conditions C. Storage location D. Storage times

12. According to ICH GCP which of the following documents should be reviewed by the IEC/IRB?
1. The Investigator’s Brochure
2. The Investigator’s CV
3. The subject compensation
4. Payment to the Investigator

A. All of them B. 1, 2 and 3 only C. 2 and 3 only D. 1 and 2 only

13. Complete the following statement from ICH GCP: Responsibility for investigational product(s) accountability at the trial site(s) rests with XXXX

A. The designated pharmacist(s) B. The investigator/institution C. The investigator or the designated pharmacist(s) if applicable D. The investigator or the designated clinical research coordinator

14.According to ICH GCP Who is responsible for selecting Investigator/Institution:

A. Monitor B. Sponsor C. Auditor D. Regulatory Authority

15.According to ICH GCP who is responsible for verifying that storage times and conditions for IMP are acceptable?

A. The investigator B. The pharmacist C. The Monitor D. The IRB/IEC

16. According to ICH GCP what should the sponsor do before entering into an agreement with the investigator/institution?

A. Provide a protocol and an up to date Investigators Brochure B. Check the qualification of investigator C. Perform a visit to assess the site D. All of the above

17.According to ICH GCP what action should the sponsor take in the event of non-compliance by investigational site staff?

A. Prompt action to secure compliance B. Immediate report to the regulatory authority C. For cause audit D. All of the above

18.According to ICH GCP which document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial:

A. Monitoring Plan B. Monitoring Report C. Monitoring File D. Monitoring Agenda

19.According to ICH GCP Payments to a subject should be

A. Prorated B. Sufficient C. Given after completion of a trial D. Given to LAR only

20.According to ICH GCP what always resides with the sponsor?

A. Ultimate responsibility for the trial B. Ultimate responsibility for subject safety C. Ultimate responsibility for the quality and integrity of the trial data D. All of the above

21. The XXXX is responsible for the ongoing safety evaluation of the investigational product.

A. Investigator B. Sponsor C. IEC/IRB D. Regulatory authority

22.In ICH GCP what is the difference in requirements between a non-therapeutic and a therapeutic clinical trial?

A. A non-therapeutic trial does not require IRB/IEC approval B. Oral or proxy consent is not normally allowable for a non-therapeutic trial C. Non-therapeutic trials are not ethical and should not be conducted D. There is no difference in requirements

23. According to ICH GCP which one of the following is NOT one of the purposes of monitoring?

A. Ensure investigator’s patients are not over researched B. Ensure informed consents are signed C. Ensure investigational site is adequate D. Ensure rights and well-being of human subjects are protected

24.According to ICH GCP the sponsor is responsible for appointing monitors. These monitors should be appropriately trained, and should have what else?

A. documented evidence of GCP training B. monitor/CRA certification C. scientific and/or clinical knowledge D. experience in the specific therapeutic area of the trial

25.ICH GCP states the protocol should generally include stopping rules for individual subjects, parts of trials and entire trial. What other term does it specify in addition to Stopping Rule?

A. Interim Analyses B. Endpoints C. Termination Criteria D. Discontinuation Criteria

26. According to ICH GCP which document should be retained to document compliance with applicable labelling regulations?

A. Certificate of analysis B. Sample of Labels C. QP release D. Drug accountability forms

27.According to ICH GCP where advertisement for subject recruitment should be filed?

A. The Sponsor file only B. The investigator file only C. Both the sponsor and investigator files D. Both the sponsor and investigator files and third party (if applicable)

28.Which of the following would NOT be considered a lay person for the purposes of IRB/IEC membership?

A. A nurse B. An Accountant C. A clerk D. A social person

29.Where the master randomization list should be filed?

A. The Sponsor file only B. The investigator file only C. Both the sponsor and investigator files and third party (if applicable) D. Both the sponsor and third party (if applicable)

30.During the clinical conduct of the trial where should monitoring reports be filed?

A. The Sponsor file only B. The investigator file only C. Both the sponsor and investigator files D. Both the sponsor and investigator files and third party (if applicable)

31.According to ICH GCP the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
1. To the monitor and auditor
2. To the IRB/IEC for review and approval/favourable opinion
3. To the sponsor for agreement and, if required
4. To the regulatory authority

A. 1 and 2 only B. 1 and 4 only C. 2, 3 and 4 only D. 1, 2 and 3 only

32. What does ICH GCP state that the members of an IRB/IEC should collectively have the qualifications and experience to review and evaluate of the proposed trial?
1. Medical aspects
2. Science
3. Statistical aspects
4. Ethics

A. 1 and 4 only B. 2, 3 and 4 only C. 1, 2 and 4 only D. All of them

33.According to ICH GCP section 8, what is the purpose of IRB/IEC composition?

A. To document that the IRB/IEC is constituted in agreement with GCP B. To document that the IRB/IEC is constituted in agreement with GCP and applicable regulatory requirements C. To document that the IRB/IEC is constituted in agreement with Sponsor’s SOP, GCP and applicable regulatory requirements D. To document that the IRB/IEC is constituted in agreement with Protocol, Sponsor’s SOP, GCP and applicable regulatory requirements

34.According to ICH GCP, The financial aspects of the trial should be documented in an agreement between:

A. Sponsor and CRO B. Sponsor and Investigator C. CRO and Investigator D. All of the above

35.Where should trial initiation report be filed?

A. The sponsor file only B. The investigator file only C. Both the sponsor and investigator files D. Both the sponsor and investigator files and third party (if applicable)

36.According to the Principles of ICH GCP before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for who?

A. Trial subjects B. Sponsor and society C. Individual trial subject and society D. Patients

37.What word is missing from this ICHGCP definition of the Audit Trail? : Documentation that allows reconstruction of the course of events.

A. Complete B. Accurate C. Written D. No word is missing

38.According to ICH GCP an IRB/IEC should safeguard the:

A. Rights and well-being of all trial subjects B. Rights and safety of all trial subjects C. Safety and well-being of all trial subjects D. Rights, safety, and well-being of all trial subjects

39.According to ICH GCP when an investigator/institutions participation is terminated because of serious and/or persistent noncompliance identified through monitoring or audit what should the sponsor do?
1. Ensure that all subjects involved in the trial at the specific site are followed up
2. Promptly notify the regulatory authority(ies)
3. Provide training to the investigational site staff
4. Ensure that all payments received by the investigator/institution are returned to the sponsor

A. 1 only B. 2 only C. 3 and 4 only D. 1 and 2 only

40. According to ICH GCP what should Sponsors provide to investigators and/or the investigators designated representatives concerning making corrections on CRFs?

A. Guidance B. Written guidelines C. CRF completion manual D. SOPs

41.Good Clinical Practice (GCP) is an international ethical and scientific quality standard for XXXX trials that involve the participation of human subjects.

A. designing B. designing and conducting C. designing, conducting and recording D. designing, conducting, recording and reporting

42.According to ICH GCP all clinical trial information should be recorded, handled, and stored in a way that allows:

A. Its accurate reporting, interpretation and completion B. Its accurate reporting, recording and interpretation C. Its accurate reporting, interpretation and verification D. Its accurate reporting, reporting and analysis

43. According to ICH GCP if the answer to a question is Investigator then what could the question be?
1. Who has responsibility for the investigational product accountability at the trial site
2. Who should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period
3. Who is responsible for the ongoing safety evaluation of the investigational product

A. 1, 2 or 3 B. 1 or 2 only C. 1 only D. 2 only

44.According to Principles of ICH GCP, A trial should be conducted in compliance with the protocol that has received prior approval/favourable opinion from:

A. Regulatory Authorities B. Institutional Review Board C. Regulatory authorities and institutional review board D. Independent data monitoring committee

45.According to ICH GCP when should the Investigator\'s Brochure be reviewed?

A. Periodically B. According to the sponsor\'s standard operating procedures C. As significant new information becomes available D. At least annually

46.According to ICH GCP which of the following is not true for multicentre trials:

A. A centralized IRB/IEC should be used for all investigators B. The CRFs are designed to capture the required data at all multicentre trial sites C. Investigators who are collecting additional data, supplemental CRFs should also be provided D. All investigators are given instructions on complying with a uniform set of standards for the assessment of clinical and laboratory findings

47. Which of the following is the ICH GCP glossary definition of a monitoring report?

A. A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. B. A document detailing the trial related compliance of a trial site compiled by a monitor following each site visit or trial related communication. C. A written report of the conduct, compliance and progress of a trial site compiled by a monitor following each site visit. D. An approved report from the site monitor of all relevant information relating to adherence to the protocol, sponsor’s SOP, GCP and, if applicable, local regulatory requirements after each site visit.

48.What is needed to complete the following statement in ICH GCP Section 4.9: Data reported on the CRF that are derived from source documents should be consistent with the source documents or XXXX

A. the source documents should be updated with single strike through, initial, date, and sign B. a file note be generated C. the discrepancies should be explained D. a data query should be raised

49.According to ICH GCP, where should subject enrolment log be filed?

A. The sponsor file only B. The investigator file only C. Both the sponsor and investigator files D. Both the sponsor and investigator files and third party (if applicable)

50.According to ICH GCP how frequently should staff be trained in GCP?

A. Annually B. Every 2 years C. When required by regulatory authorities D. There is no specific requirement

GCP Quiz

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