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SOCRA SAMPLE QUESTIONS > ICH-GCP > Flashcards

ICH-GCP Flashcards

1
Q

An audit is defined as

A

A systematic and independent examination of clinical trial related activities and documents

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2
Q

And inspection is defined as

A

Official review of documents, facilities, records and any other resources

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3
Q

Monitoring is defined as

A

Overseeing the progress of a clinical trial

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4
Q

Clinical trial is defined as

A

And investigation intended to discover and verify the clinical effects of an investigational product

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5
Q

An investigator is defined as

A

A person responsible for the conduct of the clinical trial

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6
Q

A sponsor is defined as

A

A person or entity responsible for initiation, management and financing of a clinical trial.

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7
Q

A monitor is defined as

A

A person responsible for overseeing the progress of a clinical trial

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8
Q

A sub investigator is defined as

A

And individuals supervised by the team leader

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9
Q

A coinvestigator is defined as

A

A person responsible for assuming, when needed, the responsibilities of an investigator or a team leader.

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10
Q

Quality assurance is defined as

A

Planned and systematic action to ensure that the data is generated, recorded and reported according to GCP

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11
Q

ICH-GCP Requires that a regulatory authority be given direct access to your clinical trial records. Direct access includes the ability to do

A

Examine and analyze all clinical trial records, verify the clinical trial records, reproduce any records as needed.

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12
Q

Source documents in a clinical trial referred to

A

Medical notes and pertinent parts of the medical record, laboratory and radiology findings, pathology reports, patient diaries and pharmacy records. NOT site monitoring reports!

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13
Q

Audits are generally performed by a regulatory authority where is monitoring is done by a CRO or sponsor, true or false?

A

True

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14
Q

The ethical framework cited in ICH-GCP As a framework for conducting clinical trials is

A

Declaration of Helsinki

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15
Q

The role specifically of medical physician as responsible for medical decisions is affirmed in

A

ICH and DHHS

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16
Q

Regarding informed consent in clinical trials ICH states that

A

Informed consent should be obtained from every subject

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17
Q

Regarding the protection of privacy and confidentiality, I CH

A

Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements

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18
Q

Regarding the storage and handling of investigational products ICH

A

Affirms that handling and storage should be in accordance with GMP

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19
Q

With regard to quality assurance in clinical trials ICH affirms all of the following

A

States that systems with procedures that assure quality be implemented for every aspect of the clinical trial, the sponsor is responsible for implementing and maintain quality assurance and quality control with written SOP’s, quality control will be applied to every stage of data handling.

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20
Q

Agreements between the sponsor and the investigator should be

A

In writing as part of the protocol or in a separate agreement

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21
Q

Regarding final report on completion of the clinical trial investigator should according to ICH do all of the following

A

Provide the IRB with a summary of the trials outcome, provide a report to regulatory authorities, should inform the institution.

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22
Q

According to ICH the IRB should obtain the following documents from the investigator

A

Protocol, consent, recruitment procedures, investigators brochure, payments.

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23
Q

According to ICH the copy of the CV given to the IRB should be

A

Current

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24
Q

The statement that continuing review be carried out by at least once annually is affirmed by

A

DHHS, ICH, and FDA

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25
Q

the requirements in ICH differ from DHHS requirements in

A

Requirements for review of non-therapeutic trials

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26
Q

Regarding ICH provisions for emergency use of an investigational article which of the following is applicable?

A

ICH states that if consent of subject or LAR cannot be obtained then relevant at the goal concerns and applicable regulatory requirements be addressed

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27
Q

With regard to payments to subjects ICH indicates that

A

Payments be free of coercion and undue influence, payment should be prorated, method amounts and schedule the payments be set forth in the informed consent.

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28
Q

With regard to a quorum for the IRB ICH specifies that

A

It should be stipulated in the written procedures

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29
Q

According to ICH the investigator should promptly report the following to the IRB

A

Deviations from protocol to eliminate immediate hazards, changes in risk to protocol, serious and unexpected adverse drug reactions, new information that may affect the safety of subjects.

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30
Q

According to ICH, the sponsor may request the following from the IRB

A

Written procedures and membership lists

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31
Q

According to ICH the investigator should

A

Demonstrate the potential for a recruiting the required number of subjects, have sufficient time and staff to conduct a trial, ensure that the delegated staff to be informed about the protocol, duties and the product

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32
Q

According to ICH the investigator should

A

Ascertain the reason for withdrawal of a subject, and from the subject position about subject participation and a clinical trial, and ensure the adequate care is provided for any adverse event experience by the subject

33
Q

With regard to keeping the IRB informed about the investigators brochure ICH states that

A

It is the investigators responsibility

34
Q

If the investigator implement the change in the protocol to eliminate an immediate hazard the following entities should be informed

A

The IRB, the sponsor, regulatory authority if applicable

35
Q

Responsibility for the investigational product and its accountability be assigned to

A

The pharmacist

36
Q

Accountability for the investigational product includes

A

Delivery and inventory at the trial site, use and return of the product, badge, serial numbers and expiration dates

37
Q

With regard to randomization the investigator should

A

Follow the sponsors randomization plan, and explain to the sponsor any premature unblinding due to an adverse event

38
Q

According to ICH the informed consent should be

A

Signed and dated by subject and the person obtaining consent

39
Q

The following agreements between sponsor and investigator should be documented in writing

A

Financial agreements and contracts, protocol agreement document, investigators brochure we speak and confidentiality documents

40
Q

According to ICH the case report form should be

A

Consistent with source documents, dated initialed and explained when needed, show the original when corrections are made

41
Q

Serious adverse events in a clinical trial should be reported to the sponsor according to ICH

A

Immediately

42
Q

When the IRB suspend the clinical trial it should inform

A

The institution, the sponsor, OHRP

43
Q

According to ICH the ultimate responsibility for the quality and integrity of the data rests with

A

The sponsor

44
Q

Under ICH sponsors responsibilities for electronic data handling include all the following

A

Accuracy, reliability and consistent performance guided by SOP’s, security and back up of this song and access to authorize individuals only, safeguarding of the blinding

45
Q

If the sponsor discontinues his clinical development of drug the records of the clinical trials should be retained for

A

Two years

46
Q

An ICH, with regard to the retention of records by the investigator, the sponsor

A

Can request retention for as long as the sponsor needs the data, can request retention for at least two years post IND approval according to FDA guidelines, and should notify the investigator in writing when the records are no longer needed

47
Q

According to ICH the purpose of monitoring is

A

Protect the rights and well-being of the human subjects, ensure data are accurate complete verifiable, the conduct of the trial is in agreement with a protocol, the clinical practice, and regulatory requirements

48
Q

With regard to the training of monitors ICH states that they should be

A

Appropriately trained with document of qualifications, have they needed specific scientific and clinical knowledge, and be familiar with the protocol and the consent form

49
Q

In determining the extent of monitoring the sponsors should consider

A

Objective, design, complexity, blinding & size

50
Q

The monitor should

A

Serve as the main line of communication between the sponsor and the investigator

51
Q

With regard to the investigator the monitor should

A

Verify that the investigator has adequate qualifications, resources, facilities and staff

52
Q

With regard to drug accountability the monitor should

A

Verify storage items and adequacy of supplies, verify whether eligible patients are getting the drug at the right doses, verify whether subjects are informed and trained about drug use in storage, and verify the receipt, use, return and disposition of unused drugs

53
Q

The study monitor verifies

final disposition of unused drug during

A

Study closeout visit

54
Q

The study monitor reviews case report forms during

A

Routine site visits

55
Q

The study monitor reviewed the protocol and schedule of assessments with the staff during

A

Site initiation visit

56
Q

The study monitor assess of the investigators qualification, resources in facilities during

A

Pre-study visit

57
Q

The study monitor should verify all the following

A

Informed consent, receipt and distribution of current copies of the investigators brochure, delegation of duties to staff, eligibility of enrolled subjects, recruitment rate, case report forms and source documents, and record of field visit intestine procedure is not done

58
Q

The site monitors findings should be summarized in

A

Periodic site monitoring reports

59
Q

According to ICH for noncompliance which is serious or persistent is observe the sponsor should

A

Terminate the investigators participation in the clinical trial, inform the IRB, and inform regulatory authorities

60
Q

According to ICH and multi center trials the sponsor should

A

Carefully to find the responsibilities of the coordinating site principal investigator

61
Q

Regarding protocol and GCP deviations observed by the monitor in a periodic site visit the sponsor me

A

Require that these be recorded promptly to the IRB, institute a corrected measure promptly, and or develop a CAPA plan as needed

62
Q

Regarding withdraws or dropouts among study subjects, ICH recommends that

A

They be recorded and explained on the appropriate CRFs

63
Q

ICH guidelines for trial design and protocol preparation include

A

Description of the designs, randomization and blinding, dosage regimens, stopping rules, and data recorded directly without source documents

64
Q

ICH guidelines for protocol preparation and clinical trials include

A

Inclusion and exclusion criteria, withdraw and replacement of subjects, schedule of assessments, assessments of safety and efficacy, statistical analysis, and publication policy

65
Q

Description of the investigators brochure is included in

A

ICH

66
Q

According to ICH the investigators brochure should include

A

Physical, chemical and pharmaceutical properties and formulations, non-clinical studies and putting on clinical pharmacology, pharmacokinetics and toxicology, affects in Hammond, and a summary of data and guidance for the investigator

67
Q

You must to get a brochure is a living document that is continually updated in a clinical trial to include

A

The latest non-clinical studies

68
Q

According to ICH the essential documents to be placed on file before the start of a clinical trial include

A

Investigators brochure, protocol and other sponsor agreements, informed consent, recruiting and advertising information, financial aspects and insurance information, IRB approval’s, CV for investigator and co-investigator, randomization and any coding information, and site initiation report and pre-clinical site sustainability assignments

69
Q

According to our CHD additional documents to be placed on file during a clinical trial include

A

Enrollment and screening logs, annual reports to the IRB, signature sheet, DOA, drug accountability records

70
Q

According to ICH; additional documents to be included on file after completion of the trial are

A

Final closeout study monitoring report, final record the IRB, and clinical study report to document results and interpretation of trial

71
Q

According to ICH the following statements about the involvement of a CRO in a clinical trial are correct

A

A sponsor may transfer any or all of the trial related duties and functions to a CRO, the CRO should implement quality assurance and quality control, and the delegated CRO responsibility should be specified in writing

72
Q

The medical safety officer at the sponsor carries out which duties

A

Providing medical advice during the clinical trial, assessing medical waivers of eligibility, and review of essay ease and continuance of subjects, study

73
Q

If the investigator terminates the trial at the site without prior approval from the sponsor he should inform the following in writing of his decision

A

IRB, institution, sponsor

74
Q

Regarding the issuance of a final report by the investigator that ICH advises that the investigator should

A

Inform the institution, provide the IRB with a summary of the trials outcome, and provide regulatory authorities with any reports that may be required

75
Q

According to ICH, for an investigator to be eligible to conduct a clinical trial he should be

A

Qualified by education training and experience, meet the qualifications specified by regulatory authorities in the IRB, and should provide documentary evidence of his qualifications to the sponsor and the IRB

76
Q

ICH advises the following individuals may be utilized in trial design

A

Biostatisticians, clinical pharmacology, physicians

77
Q

ICH advises that the terms of compensation for claims arising during a clinical trial the sponsor should

A

Provide insurance or indemnify the investigator

78
Q

Regarding the monitors reports ICH advises that they include

A

Maybe in written form, dated and signed, include a summary of what was reviewed, deviations and deficiencies in actions to be taken, and review and follow up of report with the sponsor

79
Q

Regarding the sponsors audits of a clinical trial ICH advises all of the following

A

Written procedures to be followed in the event of an audit the audit plan take into account the complexity and importance of the clinical trial, where applicable an audit certificate should be issued

SOCRA SAMPLE QUESTIONS (2 decks)

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