Good Clinical Practice (GCP) Training and Finding

1.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

2.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)

3.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

4.According to ICH GCP which of the following statements are true about record retention?
1. The sponsor should inform the investigator in writing of the need for record retention
2. The sponsor should notify the investigator in writing when the trial related records are no longer needed
3. It is the responsibility of the investigator to notify the IRB/IEC when the trial related records are no longer needed

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

5.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)

6.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

7.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

8. 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

9. 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

10.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

11. 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

12.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

13.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

14.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

15.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

16. 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

17.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)

18.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

19. 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

20. With which of the following should IRB/IECs comply?

A. SOPs, regulatory requirements and the protocol B. SOPs and the protocol C. Regulatory requirements and the protocol D. SOPs and regulatory requirements

21.According to ICH GCP for how long the IRB/IEC should retain all relevant records?

A. At least 2-years after completion of the trial B. At least 3-years after completion of the trial C. At least 5-years after completion of the trial D. At least 7-years after completion of the trial

22.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

23. 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

24. 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

25.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

26.“Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced” is the definition of:

A. Source Document B. Source Data C. Essential Document D. QA Audit Report

27. 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

28.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

29.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)

30.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

31. 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

32.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

33.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

34.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)

35.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

36.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

37.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

38.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

39.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

40.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

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.What is needed to complete the following statement in ICH GCP Section 4.9: Data reported on the CRF that are derived from source documents should be consistent with the source documents or XXXX

A. the source documents should be updated with single strike through, initial, date, and sign B. a file note be generated C. the discrepancies should be explained D. a data query should be raised

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

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

44. 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

45.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

46.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

47. According to ICH GCP the IRB/IEC should establish and document in writing and follow procedures for which of the following:
1. Determining its composition
2. Scheduling, notifying its members of, and conducting its meetings
3. Determining the frequency of continuing review, as appropriate
4. Training and Assessment for its members

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

48.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

49.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

50. 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

GCP Quiz

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