Good Clinical Practice (GCP) Training and Finding

1. 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

2. According to ICH GCP whose responsibility is it to ensure that the trial site staff assisting with the trial are adequately informed about trial procedures?

A. The sponsor B. The Monitor C. The Investigator D. All of them

3.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

4.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)

5.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

6.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

7.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

8. 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

9. According to ICH GCP who should be responsible for the medical care of trial subjects at site?

A. A qualified physician only B. The investigator C. The investigator or sub-investigator D. A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial

10.According to Principles of ICH GCP, Clinical trials should be conducted in accordance with the ethical principles that have their origin in the

A. ICH Regions B. Nuremberg Code C. Federal Regulations D. Declaration of Helsinki

11.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

12.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

13.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

14.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)

15.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

16.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

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, 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

19.According to ICH GCP who should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions?

A. Investigator B. Monitor C. Auditor D. All of the above

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

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

21. 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

22. 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

23.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

24.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

25.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

26.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)

27.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

28.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

29.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

30. 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

31.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

32.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

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.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)

35.Before the Clinical Phase of the Trial Commences where should the Investigator’s brochure 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.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

37.What does ICH GCP say the investigator should do in the event of premature unblinding?

A. document the date, time and reason B. promptly document and explain to the sponsor C. document and report to the sponsor and the IRB/IEC D. document and report to the sponsor, the IRB/IEC and regulatory authority (if applicable)

38.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

39.According to ICH GCP the information for clinical trial subjects should include: That the subject or the subject\'s legally acceptable representative will XXXX

A. be required to sign the consent form B. have a responsibility to inform the investigator of any change of circumstances affecting the subject\'s ability to participate in the trial C. be required to maintain confidentiality regarding the trial and the subject\'s participation in the trial D. be informed in a timely manner if information becomes available that may be relevant to the subject\'s willingness to continue participation in the trial

40.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

41. According to ICH GCP which of the following would be classified as a Contract Research Organisation?
1. An organisation providing clinical trial monitoring services to a sponsor
2. An individual freelance CRA monitoring a trial for a sponsor
3. An academic organisation providing data management services for the sponsor of a clinical trial

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

42.Who am I according to ICH GCP: A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial

A. Standard operating procedures (SOPs) B. Monitoring plan C. Monitoring strategy D. Centralized monitoring

43.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

44.Which of the following is true for subjects in emergency situations when prior consent is not possible?

A. These patients should not be included in clinical trials because they cannot give consent B. They can only be included with the consent of a relative C. The investigator has to consult the IRB/IEC on a case by case basis D. They can be included if the measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC

45.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

46.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)

47. 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

48.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

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

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

50. 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

GCP Quiz

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