Good Clinical Practice (GCP) Training and Finding

1.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

2. 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

3.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

4. 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

5. 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

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 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

8.According to ICH GCP the quality management system should use a XXXX approach.

A. Qualitative B. Documented C. Risk-based D. Approved

9. 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

10. 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

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 the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
1. To the monitor and auditor
2. To the IRB/IEC for review and approval/favourable opinion
3. To the sponsor for agreement and, if required
4. To the regulatory authority

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

13. 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

14.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

15.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

16. 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

17. 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

18.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)

19.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

20.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

21.According to ICH GCP, who can be subinvestiagtor?

A. Associates B. Residents C. Research fellows D. All of the above

22.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

23.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

24.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

25.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

26.According to ICH GCP how long should an IRB/IEC take to review a protocol and document its opinion?

A. 15 days B. 30 days C. No longer than 30 days D. A reasonable time

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

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

28. 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

29.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)

30.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

31.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)

32.Before the clinical phase of the trial commences 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)

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.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

35.According to ICH GCP Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled:
1) The negative impact on the subject’s well-being is minimized and low
2) The trial is not prohibited by law
3) The foreseeable risks to the subjects are low
4) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally

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

36.According to ICH GCP Monitors should be appointed by the sponsor. These monitors should be appropriately trained, and should have what else?

A. Documented evidence of GCP training B. Monitor certification C. Experience in the various therapeutic area of the trial D. Scientific and/or clinical knowledge needed to monitor the trial adequately

37.Which of the following statement is not true for, The IRB/IEC should establish document in writing, and follow its procedures, which should include:

A. Determining the composition and authority under which it is established B. Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in completed trials that have the approval/favourable opinion of the IRB/IEC C. Scheduling, notifying its members of, and conducting its meetings. D. Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial

38.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

39.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

40.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

41.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)

42. According to ICH GCP if the answer to a question is Investigator then what could the question be?
1. Who has responsibility for the investigational product accountability at the trial site
2. Who should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period
3. Who is responsible for the ongoing safety evaluation of the investigational product

A. 1, 2 or 3 B. 1 or 2 only C. 1 only D. 2 only

43.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

44.Where should signature sheet 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)

45. 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

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

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

47.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

48.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)

49.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

50.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

GCP Quiz

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