ICH Good Clinical Priniciples Part 1 Flashcards
In ICH-GCP an audit is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents facilities records and any other resources
d) Overseeing of the progress of a clinical trial
In ICH-GCP an audit is defined as
a) A systematic and independent examination of trial related activities and documents.
In ICH-GCP an inspection is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial
In ICH-GCP an inspection is defined as
c) Official review of documents, facilities, records and any other resources
In ICH-GCP monitoring is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial
In ICH-GCP monitoring is defined as
d) Overseeing of the progress of a clinical trial
In ICH-GCP a clinical trial is defined as
a) A systematic and independent examination of trial related activities and documents
b) An investigation intended to discover and verify the clinical effects of an investigational product
c) Official review of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial
In ICH-GCP a clinical trial is defined as
b) An investigation intended to discover and verify the clinical effects of an investigational product
In ICH-GCP an investigator is defined as
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person responsible for initiation, management and financing of a clinical trial
d) A person responsible for overseeing the progress of a clinical trial
In ICH-GCP an investigator is defined as
a) A person responsible for the conduct of the clinical trial
In ICH-GCP a sponsor is defined as:
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person/entity responsible for initiation, management and financing of a clinical trial.
d) A person/ entity responsible for overseeing the progress of a clinical trial
In ICH-GCP a sponsor is defined as:
c) A person/entity responsible for initiation, management and financing of a clinical trial.
In ICH-GCP a monitor is defined as:
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person/entity responsible for initiation, management and financing of a clinical trial
d) A person responsible for overseeing the progress of a clinical trial
In ICH-GCP a monitor is defined as:
d) A person responsible for overseeing the progress of a clinical trial
In ICH-GCP a sub-investigator is defined as:
a) A person responsible for the conduct of the clinical trial
b) An individual supervised by the team leader
c) A person/entity responsible for initiation, management and financing of a clinical trial.
d) A person responsible for overseeing the progress of a clinical trial
In ICH-GCP a sub-investigator is defined as:
b) An individual supervised by the team leader
In ICH-GCP a co-investigator is defined as
a) A person responsible for overseeing the progress of a clinical trial
b) An individual supervised by the team leader
c) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader
d) A person responsible for funding the clinical trial.
In ICH-GCP a co-investigator is defined as
c) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader.
In ICH-GCP quality assurance is defined as
a) Planned and systematic action to ensure that the data is generated recorded and reported according to GCP
b) The act of overseeing the progress of a clinical trial
c) The act of performing inspections of a clinical trial
d) The act of performing an official review of a clinical trial
In ICH-GCP quality assurance is defined as
a) Planned and systematic action to ensure that the data is generated recorded and reported according to GCP.
ICH-GCP requires that a regulatory authority be given direct access to a clinical trial records. Direct access includes the ability to do all except
a) Examine and analyze all clinical trial records
b) Verify the clinical trial records
c) Reproduce any records as needed
d) Not assume responsibility during an audit for the confidentiality of the clinical trial records.
ICH-GCP requires that a regulatory authority be given direct access to a clinical trial records. Direct access includes the ability to do all except
d) Not assume responsibility during an audit for the confidentiality of the clinical trial records.
Source documents in a clinical trial refer to all except
a) Medical notes and pertinent parts of a medical record
b) Laboratory and radiology findings
c) Pathology reports
d) Patient diaries and pharmacy records
e) Site monitoring reports
Source documents in a clinical trial refer to all except
e) Site monitoring reports
Which of the following statements is true of auditing and monitoring of a clinical trial?
a) Audits often occur prior to clinical trial enrollment as do monitoring visits
b) Audits and monitoring visit are both periodic in nature and occur throughout the progress of a clinical trial
c) Audits are generally performed by a regulatory authority whereas monitoring is done by a CRO or sponsor
d) Both audits and monitoring visits involve necessary assessments at study close out
Which of the following statements is true of auditing and monitoring of a clinical trial?
c) Audits are generally performed by a regulatory authority whereas monitoring is done by a CRO or sponsor
The ethical framework cited in ICH-GCP as the framework for conducting clinical trials is
a) Declaration of Helsinki
b) Belmont report
c) Nuremberg Code
d) CIOMS guidelines
The ethical framework cited in ICH-GCP as the framework for conducting clinical trials is
a) Declaration of Helsinki
Which of the following statements about risk in clinical trials does not apply to ICH-GCP?
a) Foreseeable risk should be weighed against anticipated benefit
b) Anticipated benefit should justify the risk
c) The well-being of the subject should prevail over the interests of science and society
d) The importance of the objective may in certain circumstances outweigh the risk to the subject
Which of the following statements about risk in clinical trials does not apply to ICH-GCP?
d) The importance of the objective may in certain circumstances outweigh the risk to the subject
Which of the following regarding the protocol for a clinical trial is correct
a) The protocol should reflect sound design as affirmed in DHHS but not ICH
b) The protocol should reflect sound design as reflected in ICH but not DHHS
c) The protocol should reflect sound design as affirmed in both ICH and DHHS
d) There is no reference to sound design in either DHHS or ICH.
Which of the following regarding the protocol for a clinical trial is correct
c) The protocol should reflect sound design as affirmed in both ICH and DHHS.
The role specifically of medical physician as responsible for medical decisions is affirmed in
a) DHHS only
b) ICH and DHHS
c) ICH only
d) OHRP
The role specifically of medical physician as responsible for medical decisions is affirmed in
b) ICH and DHHS
The requirement that each individual involved in conducting a clinical trial should be qualified by education and training is affirmed in
a) ICH only
b) ICH and the FWA only
c) ICH, FWA and NIH guidelines
d) Not explicitly stated in the regulations
The requirement that each individual involved in conducting a clinical trial should be qualified by education and training is affirmed in
c) ICH, FWA and NIH guidelines.
Regarding informed consent in clinical trials ICH states that
a) Waivers of informed consent are possible
b) Waiver of documentation of informed consent may be given
c) Informed consent should be obtained from every subject
d) Parental permission should be given only when it is a reasonable protection
Regarding informed consent in clinical trials ICH states that
c) Informed consent should be obtained from every subject.
Regarding the protection of privacy and confidentiality, ICH:
a) States that specific guidelines be followed for the protection of confidentiality
b) Affirms the principles of HIPAA in privacy and confidentiality
c) Does not mention privacy and confidentiality explicitly in its guidelines
d) Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements
Regarding the protection of privacy and confidentiality, ICH:
d) Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements
Regarding the storage and handling of investigational products ICH
a) Assigns the responsibility to the principal investigator only
b) Assigns responsibility to the CRO and study monitor
c) Does not mention storage and handling
d) Affirms that handling and storage be in accordance with GMP.
Regarding the storage and handling of investigational products ICH
d) Affirms that handling and storage be in accordance with GMP.
With regard to quality assurance in clinical trials ICH affirms of all of the following except
a) States that systems with procedures that assure quality be implemented for every aspect of the clinical trial
b) The sponsor is responsible for implementing and maintain quality assurance and quality control with written SOPs
c) Quality control be applied to every stage of data handling
d) The IRB should review the quality control measures of a clinical trial.
With regard to quality assurance in clinical trials ICH affirms of all of the following except
d) The IRB should review the quality control measures of a clinical trial.
Agreements between the sponsor and the investigator:
a) Should be In writing as part of the protocol or in a separate agreement
b) May be verbally implemented
c) Must be provided to the IRB prior to study approval
d) May be signed by the CRO on behalf of the sponsor
Agreements between the sponsor and the investigator:
a) Should be In writing as part of the protocol or in a separate agreement.
Regarding final report on completion of the clinical trial, the investigator should according to ICH do all of the following except
a) Provide the IRB with a summary of the trials’ outcome
b) Provide a report to regulatory authorities
c) Should inform the institution
d) Is similar to DHHS in its requirements
Regarding final report on completion of the clinical trial the investigator should according to ICH do all of the following except
d) Is similar to DHHS in its requirements.
According to ICH, the IRB should obtain the following documents from the investigator
a) Protocol, consent, recruitment procedures, investigator’s brochure, payments
b) Protocol, consent, case report forms, payments, CV
c) Protocol, consent, monitoring plan, payments, CV, recruitment
d) Protocol, monitoring plan, investigator’s brochure, payments, CV
According to ICH the IRB should obtain the following documents from the investigator
a) Protocol, consent, recruitment procedures, investigator’s brochure, payments.
According to ICH, the copy of the CV given to the IRB should be
a) No more than a year old
b) No more than two years old
c) No date on the CV is required
d) Current
According to ICH the copy of the CV given to the IRB should be
d) Current
The statement that continuing review be carried out at least once annually is affirmed by
a) ICH only
b) DHHS and ICH only
c) DHHS only
d) DHHS, ICH, and FDA.
The statement that continuing review be carried out at least once annually is affirmed by
d) DHHS, ICH, and FDA.
The IRB requirements in ICH differ from DHHS requirements in
a) Requiring annual continuing review
b) Ability for approval or disapproval
c) Ability for termination or suspension
d) Requirements for review of non-therapeutic trials.
The IRB requirements in ICH differ from DHHS requirements in
d) Requirements for review of non-therapeutic trials.
Regarding ICH provisions for emergency use of an investigational article which of the following is applicable?
a) ICH describes guidelines for emergency use similar to those required by the FDA.
b) ICH makes a provision for emergency medical care similar to that provided in DHHS
c) ICH describes guidelines for use of an investigational article in an emergency setting
d) ICH states that if consent of subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed.
Regarding ICH provisions for emergency use of an investigational article which of the following is applicable?
d) ICH states that if consent of subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed.
With regard to payments to subjects ICH indicates that
a) Payments be free of coercion and undue influence
b) Payments should be prorated
c) Methods, amounts and schedule of payments be set forth in the informed consent.
d) All of the above.
With regard to payments to subjects ICH indicates that
d) All of the above.
The guidelines for IRB composition in ICH are the same as those in
a) DHHS only
b) FDA only
c) DHHS and FDA
d) CIOMS
The guidelines for IRB composition in ICH are the same as those in
c) DHHS and FDA
An important affirmation regarding the ICH guidelines for the IRB which differ from DHHS regulation is that
a) The IRB should comply with GCP
b) Should have at least five members
c) Should have a non-scientific member
d) Should have a non-affiliated member
An important affirmation regarding the ICH guidelines for the IRB which differ from DHHS regulation is that
a) The IRB should comply with GCP
With regard to a quorum for the IRB ICH specifies that
a) It is majority of members
b) It is more than 50% of the roster
c) It is governed by a specified formula
d) It should be stipulated in the written procedures
With regard to a quorum for the IRB ICH specifies that
d) It should be stipulated in the written procedures
With regard to ICH, conflict of interest on the IRB, which of the following is not correct:
a) The IRB may invite non-members but only members can vote
b) The investigator may not participate in deliberations or the vote
c) There is no provision for non-tangible conflict of interest
d) Conflict of interest is defined as financial interest greater than $10000.
With regard to ICH, conflict of interest on the IRB, which of the following is not correct:
d) Conflict of interest is defined as financial interest greater than $10000.
That the investigator may make changes in a protocol without IRB approval to eliminate an immediate hazard is stated in
a) DHHS only
b) ICH only
c) DHHS and ICH
d) Not stated exactly in either DHHS or ICH.
That the investigator may make changes in a protocol without IRB approval to eliminate an immediate hazard is stated in
c) DHHS and ICH.
