Good Clinical Practice (GCP) Training and Finding

1.According to ICH GCP, Integrated Addendum provides a unified standard for which of the countries to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions?

A. European Union, Japan, the United States B. Canada, Switzerland C. a only D. both a and b

2. 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

3.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

4.According to the Principles of ICH GCP before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for who?

A. Trial subjects B. Sponsor and society C. Individual trial subject and society D. Patients

5.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

6.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

7.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)

8.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

9.According to ICH GCP adverse events, concomitant medications and intercurrent illnesses are reported XXXX on the CRFs.

A. in accordance with the protocol B. in a timely manner C. accurately D. with detailed description

10.According to ICH GCP the sponsor should not supply an investigator/institution with the investigational product(s) until what has happened?

A. the sponsor obtains the batch release certificate B. the sponsor obtains all required documentation C. the QP signs the release certificate D. a favourable opinion is received from the IRB/IEC

11.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

12.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

13. 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

14. According to ICH GCP Adverse events and/or laboratory abnormalities identified in the protocol as critical evaluations should be reported to the:

A. Sponsor B. Sponsor and IRB/IEC C. IRB/IEC and Monitor D. Sponsor, IRB/IEC and applicable regulatory authority

15.According to ICH GCP The investigator should submit written summaries of the trial status to the IRB/IEC:

A. 2-years after the IRB/IEC approval date B. Annually and as new information becomes available C. Annually, or more frequently, if requested by the IRB/IEC D. Annually

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

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

17. 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

18.According to ICH GCP the IRB/IEC should promptly notify in writing:

A. Its trial-related decisions/opinion B. The reasons for its decisions/opinions C. Procedures for appeal of its decisions/opinions D. All of the above

19.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

20.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

21.According to ICH GCP Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be XXXX, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).

A. Original B. Visible C. Traceable D. Clear

22. 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

23.What is the definition of source data verification according to the ICH GCP?

A. The act of reviewing data in a clinical trial, in order to verify that it is conducted, recorded, and reported in accordance with the protocol B. Review of all information in original records and certified copies of original records of clinical findings and observations C. The operational activities undertaken to verify that the requirements for quality of the trial-related activities have been fulfilled. D. There is no definition of the term Source Data Verification in ICH GCP

24.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

25.During the clinical conduct of the trial how completed CRFs 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)

26.According to Principles of ICH GCP Investigational products should be manufactured, handled, and stored in accordance with applicable XXXX

A. Good Clinical Practice B. Good Manufacturing Practice C. Good Laboratory Practice D. All of the above

27.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

28.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

29.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

30.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

31.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

32. What am I according to ICH GCP - Any public or private entity or agency or medical or dental facility where clinical trials are conducted

A. Trial site B. Investigational site C. Institution (medical) D. Trial institution

33.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

34.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

35. 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

36.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

37.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)

38.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)

39. 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

40.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

41.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

42.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

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

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

44.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

45.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

46.Which of the following is the ICH GCP Glossary Definition of Coordinating Committee?

A. A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. B. A committee that an ethics committee may organize to coordinate the conduct of a multicentre trial. C. A committee that a CRO may organize to coordinate the conduct of a multicentre trial. D. There is no specification

47. 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

48.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

49.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)

50. 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

GCP Quiz

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