Good Clinical Practice (GCP) Training and Finding

1.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)

2.According to ICH GCP, the definition of Sponsor-Investigator is: An individual who XXXX, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject.

A. both funds and initiates B. both sponsors and conducts C. both initiates and conducts D. both funds and conducts

3.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

4.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)

5. According to ICH GCP Section 5.8 Compensation to Subjects and Investigators which of the following is not true:

A. Sponsor Should provide insurance B. Sponsor Should indemnify investigator against claims arising from negligence C. Sponsor Should indemnify investigator against claims arising from malpractice D. Both b and c

6.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

7. 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

8. 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

9.According to ICH GCP, the location(s) where trial-related activities are actually conducted is defined as:

A. Institution B. Trial Site C. Research Centre D. Investigative Site

10. 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

11.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

12.Monitor should verify for the investigational product(s) that:
1) Investigational product(s) are supplied only to subjects who are eligible to receive it
2) Subjects are provided with necessary instruction on properly using investigational products
3) Receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately
4) Storage times and conditions are acceptable

A. 1, 2 and 3 B. 1, 3 and 4 C. 2, 3 and 4 D. All of the above

13.Which of the following statement is true according to ICH GCP for the purposes of trial monitoring:

A. The rights and well-being of human subjects are protected B. The rights, safety and well-being of human subjects are protected C. The rights of investigators are protected D. The recruitment timelines are met

14.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

15. According to ICH GCP the sponsor should take steps to ensure that the investigational product(s) are stable over what?

A. The period of use B. The duration of the trial C. The expected duration of follow-up D. Up to the expiry date on the investigational product

16.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

17. 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

18. 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

19.According to ICH GCP who is responsible for destruction of Investigational Product(s)?

A. The sponsor B. The Investigator C. The Subject D. The Pharmacist

20.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)

21.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

22. 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

23.The Investigator\'s Brochure (IB) is a compilation of the XXXX on the investigational product(s) that are relevant to the study of the product(s) in human subjects.

A. clinical data B. nonclinical data C. clinical and nonclinical data D. previous study data

24.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

25.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

26.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

27.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)

28. 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)

29. According to ICH GCP what is the sponsor responsibility regarding supply of Investigational Products?

A. To ensure the IP is manufactured, handled and supplied according to the GMP B. To advise the investigator on obtaining IP, supplying it if necessary C. To decide whether supplying IP is in the best interests of the trial D. To supply IP to the investigator

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.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

32.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

33. Which of the following should not appear in a monitoring visit report?

A. The name of the monitor B. Details of issues which have been resolved C. Information about what happened during the visit D. The opinion of monitor for site

34.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

35.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

36.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)

37. 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

38.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

39.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

40.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

41. 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

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

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

43. 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

44.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

45.According to ICH GCP Section 5.18 Monitoring, which of the following is NOT stated under the section entitled selection and qualification of monitors:

A. Monitors should be appointed by the sponsor B. Monitors should be thoroughly familiar with the safety reporting procedures of the trial and should ensure the training is documented and updated on a regular basis C. Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s) D. Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented

46. According to ICH GCP if the trial is prematurely terminated or suspended for any reason, the investigator/institution should do which of the following as well as notifying IRB/IEC and local regulatory authorities:
1. Return all IMP to the sponsor immediately
2. Contact all subjects to ensure immediate return of all IMP
3. Promptly inform the trial subject
4. Should assure appropriate therapy and treatment follow-up for the subjects

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

47. 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

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

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

49.According to ICH GCP, if a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should what?

A. be present during the entire informed consent discussion B. sign the informed consent document on behalf of the subject C. be available to explain the process to the subject D. both a and b

50. 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

GCP Quiz

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