Good Clinical Practice (GCP) Training and Finding

1. 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

2.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

3.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

4. Who is responsible for all trial-related medical (or dental) decisions?

A. A qualified physician B. A qualified dentist C. A qualified physician or dentist D. Sponsor Medical Monitor

5.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

6.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

7.According to ICH GCP Section 5.18 which of the following is not stated as one of the determinants of the extent and nature of monitoring?

A. Blinding B. Design C. Phase D. Size

8.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

9.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

10.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

11.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

12.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

13.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

14.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

15. In ICH GCP what is the recommended timeline for the monitor to write the monitoring report?

A. As soon as possible B. After completion of a site visit C. Within a reasonable time D. There is no recommendation regarding the timeline

16.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

17.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

18.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

19. 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

20.According to ICH GCP double blind usually refers to the XXXX being unaware of the treatment assignment(s).

A. subject and investigator B. subject, investigator and in some cases, monitor C. subject, investigator, monitor and in some cases, statistician D. subject, investigator, monitor and in some cases, data analyst

21. 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

22. 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

23.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)

24. 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

25.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

26.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

27. 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

28.According to ICH GCP how serious adverse events (SAEs) should be reported by the investigator?

A. Within 7 days to regulatory authority B. Immediately to the sponsor C. To sponsor, ethics committee and regulatory authority as soon as possible D. Immediately to the sponsor and within 7 days to the ethics committee

29. 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

30. 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)

31. 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

32.The investigator(s) should be qualified by XXXX to assume responsibility for the proper conduct of the trial.

A. Training and experience B. Education and training C. Education, training, and experience D. Education, training, and relevant experience

33.According to ICH GCP which of the following is NOT one of the procedures generally included in protocols regarding Subject Withdrawal Criteria?

A. How to define withdrawals due to lack of efficacy, safety or subject no longer wanting to continue B. When and how to withdraw subjects from the trial C. The type and timing of the data to be collected for withdrawn subjects D. Whether and how subjects are to be replaced

34.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

35.According to Principles of ICH GCP, a trial should be initiated and continued only if:

A. It benefit for the individual trial subject and society B. The anticipated risks justify the benefits C. The anticipated benefits justify the risks D. There is no risk

36.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

37.Good Clinical Practice (GCP) is an international ethical and scientific quality standard for XXXX trials that involve the participation of human subjects.

A. designing B. designing and conducting C. designing, conducting and recording D. designing, conducting, recording and reporting

38.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

39.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

40. 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

41.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

42. According to ICH GCP if centralised monitoring is used what else should be in place?

A. Extensive written guidance B. Investigator meeting C. Investigator Training D. All of the above

43. 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

44.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

45.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

46. 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

47.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)

48.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

49.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)

50. 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

GCP Quiz

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