Good Clinical Practice (GCP) Training and Finding

1.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

2.What words are missing from the statement in ICH GCP: The investigator should be XXXX and should comply with GCP and the applicable regulatory requirements.

A. signed off against B. knowledgeable in C. trained in D. aware of

3.According to ICH GCP the quality management system should use a XXXX approach.

A. Qualitative B. Documented C. Risk-based D. Approved

4.According to ICH GCP who is responsible for training the investigator in GCP?

A. The sponsor (Monitor) B. The institution C. The regulatory authority D. There is no specification

5.According to ICH GCP for how long the IRB/IEC should retain all relevant records?

A. At least 2-years after completion of the trial B. At least 3-years after completion of the trial C. At least 5-years after completion of the trial D. At least 7-years after completion of the trial

6.According to ICH GCP results of monitoring activities should be documented in sufficient detail to allow verification of what?

A. Compliance with the monitoring plan B. Compliance with GCP C. Compliance with applicable regulatory requirement(s) D. Compliance with Protocol

7.Before the clinical phase of the trial commences where should master randomization list be filed?

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

8.According to ICH GCP it is recommended that the IRB/IEC should include at least five members. However, as this is a recommendation ICH GCP also references the number of members in the following statement. \"The IRB/IEC should consist of XXXX\"

A. at least two members B. at least one member whose secondary area of interest is in non-scientific area C. the number of members stated in its procedures D. a reasonable number of members

9.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

10.According to ICH GCP Monitors should be appointed by the sponsor. These monitors should be appropriately trained, and should have what else?

A. Documented evidence of GCP training B. Monitor certification C. Experience in the various therapeutic area of the trial D. Scientific and/or clinical knowledge needed to monitor the trial adequately

11.Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs:

A. Auditor B. Monitor C. Sponsor D. Investigator

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

A. At least once a year B. At intervals appropriate to the degree of risk to human subjects, but at least once per year C. At intervals appropriate to the degree of risk to human subjects, but at least once during the accrual period of the trial D. There is no guidance provided

13.According to ICH GCP who should obtain informed consent from subjects?

A. The investigator B. The investigator or a person designated by the investigator C. The investigator or another physician designated by the investigator D. The investigator or another dentist designated by the investigator

14.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

15.During the clinical conduct of the trial how documentation of CRF correction be filed?

A. Copy in Sponsor file and original in investigator file B. Copy in investigator file and original in sponsor file C. Copy in sponsor and investigator files, original in subject’s medical records D. Copy in sponsor and investigator files, original at third party (if applicable)

16.Which of the following is not in the list given by ICH GCP for the factors guiding the audit plan and procedures for a trial audit?

A. importance of the trial to submissions to regulatory authorities B. number of subjects in the trial C. type of the trial D. duration of treatment for each trial subject

17.According to ICH GCP, who may be asked the IRB/IEC to provide its written procedures and membership lists

A. Investigator B. Sponsor C. Regulatory D. All of them

18.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)

19.Where should final trial close-out monitoring report be filed?

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

20.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

21.According to ICH GCP, Documentation that allows reconstruction of the course of events is:

A. Case Report Form (CRF) B. Source Document C. Audit trail D. Certified Copy

22.What words are missing from the following in ICH GCP: The Sponsor should update the XXXX as significant new information becomes available?

A. Protocol B. CRF C. Investigator’s Brochure D. Informed Consent Form

23.According to ICH GCP how long should an IRB/IEC take to review a protocol and document its opinion?

A. 15 days B. A reasonable time C. 30 days D. No longer than 30 days

24. 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.

25.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

26.According to the ICH GCP Well-being is the physical and mental XXXX of the subjects participating in a clinical trial.

A. Health B. Condition C. Integrity D. Status

27.Where should signature sheet 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.According to ICH GCP The investigator should submit written summaries of the trial status to the IRB/IEC:

A. 2-years after the IRB/IEC approval date B. Annually and as new information becomes available C. Annually, or more frequently, if requested by the IRB/IEC D. Annually

29.Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the:

A. Protocol Synopsis B. Protocol C. Protocol and Investigator’s Brochure D. Protocol, ICF and Investigator’s Brochure

30.The ICH GCP guideline should be read in conjunction with other ICH guidelines relevant to the xxxx of clinical trials

A. Therapeutic area B. Conduct C. Safety D. Applicability

31.According to ICH GCP how long should an IRB/IEC take to review a protocol and document its opinion?

A. 15 days B. 30 days C. No longer than 30 days D. A reasonable time

32.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

33.What words are missing from the following statement in ICH GCP: For XXXX the investigator should supply the sponsor and the IRB/IEC with any additional requested information?

A. reported adverse events B. reported serious adverse events C. reported Suspected unexpected Serious Adverse Reactions D. reported deaths

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

A. at least once a year B. at intervals appropriate to the degree of risk to human subjects, but at least once per year C. at intervals appropriate to the degree of risk to human subjects, but at least once during the accrual period of the trial D. there is no guidance provided

35.According to ICH GCP how much source data verification (SDV) should be done?

A. 100% SDV should be done by a monitor B. 100% SDV should be done by a monitor and 20% SDV should be done by an auditor C. There is no specification D. Only those which are permitted by investigator

36.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

37.According to ICH GCP, XXXX is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons?

A. Data management B. Source document verification C. Centralized monitoring D. Audit

38.According to ICH GCP where would you file the Signed Informed Consent Forms?

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

39.Investigator, should fully inform the subject if the subject is unable to provide informed consent, the XXXX, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC:

A. Investigator designated individual B. Impartial Witness C. Subject’s legally acceptable representative D. Both b and c

40.During the clinical conduct of the trial where should new batches of certificate of analysis of 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)

41.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

42.During the clinical conduct of the trial how completed CRFs be filed?

A. Copy in Sponsor file and original in investigator file B. Copy in investigator file and original in sponsor file C. Copy in sponsor and investigator files, original in subject’s medical records D. Copy in sponsor and investigator files, original at third party (if applicable)

43.According to ICH GCP, Integrated Addendum provides a unified standard for which of the countries to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions?

A. European Union, Japan, the United States B. Canada, Switzerland C. a only D. both a and b

44.Which is the following is NOT included in protocol section 6.5 selection and withdrawal of subjects:

A. Subject inclusion criteria B. Subject exclusion criteria C. Subject withdrawal criteria D. Subject retention criteria

45.Where should the audit certificate be filed?

A. The Sponsor file B. The Investigator file C. Both the sponsor and investigator file (where required) D. Both the sponsor (where required) and investigator file

46.Which of the following are not part of the risk-based approach of quality management system:

A. Critical Process and Data Identification B. Risk review C. Risk analysis D. Risk reporting

47.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

48.According to ICH GCP If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the:

A. Investigators and regulatory authorities B. Investigators and IRB/IECs C. Investigators, IRB/IECs and regulatory authorities D. Investigators only

49.Before the clinical phase of the trial commences 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)

50.Which of the following is true for centralized monitoring as per ICH GCP:

A. Remote evaluation of accumulating data B. Performed in a timely manner C. Supported by appropriately qualified and trained persons D. All of the above

GCP Quiz

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