Good Clinical Practice (GCP) Training and Finding

1. According to ICH GCP the sponsor should evaluate the identified risks, against existing risk controls by considering:

A. The impact of such errors on human subject protection and reliability of trial results B. The extent to which such errors would be detectable C. The likelihood of errors occurring D. All of the above

2.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

3. According to ICH GCP when can an investigator implement a deviation from, or change to a protocol without agreement of the sponsor and prior approval/favourable opinion of the IRB/IEC?
1. Newer
2. To eliminate an immediate hazard to trial subjects
3. When advised by the Monitor
4. When the change involves only logistical or administrative aspects

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

4.Complete this segment from ICH GCP regarding what IMP procedures for sites should include: adequate and safe receipt, handling, storage, dispensing, XXXXXX, and return of unused investigational product(s) to the sponsor

A. temperature control B. usage C. retrieval of unused product from subjects D. there is nothing missing

5.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

6.According to ICH GCP section 5.2 Contract Research Organization, Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in:

A. Protocol B. Clinical Trial Agreement C. Writing D. Contract

7.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

8.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)

9. According to ICH GCP which of the following is NOT listed under investigator responsibilities for investigational product?

A. Maintain records of the investigational product delivery to the site B. Explain the correct use of the investigational product(s) to each subject C. Ensure that the investigational product(s) are used only in accordance with the approved protocol D. These are all included

10.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

11.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

12.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

13.Where should subject identification code 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 investigator files and third party (if applicable)

14.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

15.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)

16.Which of the following most accurately describes the extent of monitoring as required by ICH GCP?

A. The Sponsor should ensure that studies are adequately monitored B. In general on site monitoring is required every 4-6 weeks C. In general on site monitoring is required before, during and after the study D. Both a and c

17.According to ICH GCP the review and follow-up of the monitoring report with the sponsor should be documented by the:

A. Monitor B. Project Manager C. Investigator D. Sponsor’s designated representative

18.Which of the following is/are principle(s) of ICH GCP?

A. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. B. A trial should be initiated only if the anticipated benefits justify the risks C. A trial should be initiated only if the anticipated benefits justify the risks D. All of the above

19.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

20.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

21.According to section 5 of ICH GCP, Sponsor, when should the monitor submit a written report to the sponsor?

A. After each trial-site visit B. As defined in the Sponsor SOPs C. After each trial-site visit or trial-related communication D. As defined in the protocol, SOPs and local regulatory requirements

22.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

23.According to ICH GCP addendum the sponsor should develop a systematic, prioritized, XXXX approach to monitoring clinical trials.

A. Approved B. Inspected C. Audited D. Risk-based

24.The monitoring plan should describe the monitoring strategy, the responsibilities, the monitoring methods to be used, and:

A. The rational for the monitoring methods B. The qualifications of the monitor C. The requirement of audit after monitoring D. The source data verification plan

25.Section 5.19.2 of ICH GCP states that: The sponsor should ensure that the auditors are qualified by XXXXX to conduct audits properly. What words are missing?

A. training and education B. therapeutic and operational training C. the sponsor in relation to the trial SOPs D. training and experience

26.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

27.According to ICH GCP what is the purpose of updates of medical/laboratory tests?

A. To document laboratory is certified throughout the trial period B. To document laboratory is accredited throughout the trial period C. To document tests remain adequate throughout the trial period D. To establish quality control and/or external quality assessment

28.According to ICH GCP adverse events, concomitant medications and intercurrent illnesses are reported XXXX on the CRFs.

A. in accordance with the protocol B. in a timely manner C. accurately D. with detailed description

29.Where the sample of labels attached to IMP container should be filed?

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)

30. What is the IRB/IEC composition recommendation in ICH GCP?

A. At least five members, at least one member whose primary area of interest is in a nonscientific area, at least one member who is from institution/trial site B. At least five members, at least one member whose primary area of interest is in a scientific area, at least one member who is from institution/trial site C. At least five members, at least one member whose primary area of interest is in a scientific area, at least one member who is independent of institution/trial site D. At least five members, at least one member whose primary area of interest is in a non-scientific area, at least one member who is independent of institution/trial site

31. 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

32.ICH GCP groups essential documents into three sections. What are they grouped according to?

A. Sponsor, Investigator, IRB/IEC B. Clinical, Nonclinical, PMS C. Purpose, Investigator Site File, Sponsor Site File D. Stage of a trial

33.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

34.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

35. According to ICH GCP Adverse events and/or laboratory abnormalities identified in the protocol as critical evaluations should be reported to the:

A. Sponsor B. Sponsor and IRB/IEC C. IRB/IEC and Monitor D. Sponsor, IRB/IEC and applicable regulatory authority

36.According to ICH GCP which documents, document the existence of the subject and substantiate integrity of trial data collected?

A. Informed Consent B. Source Documents C. Subject Enrolment log D. Subject Identification log

37. According to the Principles of ICH GCP all clinical trial information should be recorded, handled, and stored in a way that allows what?

A. Its accurate reporting, interpretation and verification B. Its accurate reporting, interpretation, identification and verification C. The trial objectives to be fulfilled and the results verified D. Auditors/monitors to verify the accuracy of data

38. 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

39.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

40. 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

41.According to ICH GCP Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be XXXX, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).

A. Original B. Visible C. Traceable D. Clear

42.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

43.Sponsor is responsible for XXXX of the investigational product?

A. Safety assessment B. Efficacy assessment C. Safety evaluation D. Efficacy evaluation

44. 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

45.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

46.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

47.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

48. The IRB/IEC should ensure that information regarding payment to subjects, including the XXXX to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.

A. Method and amount of payment B. Method, amount and prorated payment C. Schedule of payment and prorated payment D. Method, amount and schedule of payment

49. The investigator should submit XXXX to the IRB/IEC annually

A. SAE reports B. Subject recruitment targets C. Written summaries of the trial status D. Protocol amendments

50. According to ICH GCP All serious adverse events (SAEs) should be reported immediately to the:

A. Sponsor B. Sponsor and IRB/IEC C. Sponsor, IRB/IEC and Institution D. Applicable regulatory authority

GCP Quiz

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