Good Clinical Practice (GCP) Training and Finding

1.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)

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

A. Monitoring Agenda B. Monitoring Plan C. Monitoring Procedures D. Monitoring Follow-up

3. According to ICH GCP where would you routinely find a description of - Actions taken or to be taken and/or actions recommended to secure compliance?

A. Initiation Visit Report B. Monitoring Report C. Audit Report D. Close Out Visit Report

4. 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

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

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

6.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

7. Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the:
1. Protocol
2. Consent form updates
3. Subject recruitment procedures
4. Written informed consent form

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

8. According to ICH GCP section 5.4.1 the sponsor should utilize qualified individuals as appropriate throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports. Which specific roles does ICH GCP provide as examples of qualified individuals?
1. Biostatisticians
2. Clinical Pharmacologists
3. Monitors
4. Physicians

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

9. 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

10.According to ICH GCP both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the:
1) The expected duration of the subjects participation
2) The approximate number of subjects agreed to participate in the trial
3) The approximate number of subjects involved in the trial
4) The expected number of subjects withdraw from the trial

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

11. After the end of the study where should the completed subject identification code list 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)

12.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

13. Which of the following is most true of Source Data Verification?

A. It is not a requirement but is considered best practice B. It is a requirement of ICH GCP, although the term Source Data Verification does not appear in ICH GCP C. Good CRF review can replace SDV in certain circumstances D. SDV is not required for Electronic Data Capture

14.According to ICH GCP which of the following statements are true about record retention?
1. The sponsor should inform the investigator in writing of the need for record retention
2. The sponsor should notify the investigator in writing when the trial related records are no longer needed
3. It is the responsibility of the investigator to notify the IRB/IEC when the trial related records are no longer needed

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

15.Which of the following documents should be obtained by IRB/IEC as per ICH GCP?

A. Subject recruitment sites B. Subject recruitment procedures C. Subject recruitment updates D. Subject recruitment strategy

16. Prior to initiating a trial the sponsor should do what?

A. Document the roles and responsibilities of the sponsor, CRO and other functions B. Define, establish and allocate all trial related duties and functions C. Ensure that each person involved in the trial has received adequate training D. Ensure that all relevant documents are defined and filed

17.During the clinical conduct of the trial where should signed informed consent forms 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)

18. 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

19. According to ICH GCP when should the sponsor update the Investigators Brochure?

A. Periodically B. According to the standard operating procedures of sponsor C. As significant new information becomes available D. Annually

20.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

21.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

22. 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

23.Who should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents?

A. Sponsor B. Regulatory authority C. Monitor D. Institutional Review Board/Independent Ethics Committee

24.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

25.What does ICH GCP section 5.18.3 Extent and Nature of Monitoring, state about the method of statistically controlled sampling?

A. may be an acceptable method for selecting the data to be verified B. is an acceptable method for selecting the data to be verified C. is an acceptable method for selecting the subjects to be monitored D. may be an acceptable method for selecting the number of subjects to be monitored

26.According to ICH GCP contract is XXXX, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters.

A. Original B. On Paper C. Written D. Official

27.Before the clinical phase of the trial commences where should certificate of analysis of investigational product(s) shipped 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.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)

29.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

30. What is the definition of unexpected in terms of ADRs?

A. Its never been seen before B. The study staffs wasn’t expecting it in that particular patient C. The patient wasn’t expecting it D. The nature or severity of which is not consistent with the applicable product information

31.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

32.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)

33.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

34.Where the advertisement for subject recruitment should be filed?

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

35. 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

36.Which of the following is the ICH GCP Glossary Definition of a Protocol Amendment?

A. All changes to a protocol that will impact on the inclusion, dosing, recording or follow-up of trial subjects B. Any change(s) to a protocol that will result in change(s) to the inclusion, dosing, recording or follow-up of trial subjects C. Change(s) to a protocol that will result in change(s) to conduct of the trial D. A written description of a change(s) to or formal clarification of a protocol

37.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

38. According to section 5.17 the sponsor should expedite the reporting to all concerned Investigator/Institution, XXXX of all ADRs that are both serious and unexpected.

A. IRB/IEC B. Regulatory Authority C. IRB/IEC and Regulatory Authority D. No word is missing

39.Which of the following most closely describes a legal representative for the purposes of consent under ICH GCP

A. The nearest available relative of the subject B. An individual or body authorised under applicable law C. A person who is independent of the trial and trial site D. The person with legally recognised duty of care for the subject

40. According to ICH GCP which of the following lists are required for clinical trials to be compliant with ICH GCP:
1. A list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
2. A list of IRB/IEC members and their qualifications
3. A list of the individuals who are authorized to make data changes

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

41.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

42.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)

43.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)

44. 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

45.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

46.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

47.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

48.The ICH GCP Guideline Integrated Addendum provides a unified standard for the XXXX to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.

A. European Union, Japan and United States B. Australia, Canada, the Nordic countries C. European Union, Japan, the United States, Canada, and Switzerland D. European Union, Japan, the United States, Canada, Switzerland and China

49.According to ICH GCP The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the:

A. Protocol B. Investigator’s brochure C. Product information D. All of the above

50.ICH GCP states the scientific integrity of the trial and the credibility of the data from the trial depend substantially on the XXXX

A. trial objectives and purpose B. trial design C. study conduct D. right subject selection

GCP Quiz

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