Good Clinical Practice Flashcards by Ashley O’Neil

In ICH-GCP an audit is defined as
A.) A systemic 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

A.) A systemic and independent examination of trial related activities and documents

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In ICH-GCP an inspection is defined as
A.) A systemic 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

C.) Official review of documents facilities records and any other resources

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In ICH-GCP monitoring is defined as
A.) A systemic 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

D.) Overseeing of the progress of a clinical trial

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In ICH-GCP a clinical trial is defined as
A.) A systemic 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

B.) An investigation intended to discover and verify the clinical effects of an investigational product

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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

A.) A person responsible for the conduct of the clinical trial

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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 responsible for initiation, management and financing of a clinical trial
D.) A person responsible for overseeing the progress of a clinical trial

C.) A person responsible for initiation, management and financing of a clinical trial

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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 responsible for initiation, management and financing of a clinical trial
D.) A person responsible for overseeing the progress of a clinical trial

D.) A person responsible for overseeing the progress of a clinical trial

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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 responsible for initiation, management and financing of a clinical trial
D.) A person responsible for overseeing the progress of a clinical trial

B.) An individual supervised by the team leader

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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

C.) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader

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ICH-GCP requires that a regulatory authority be given direct access to a clinical trial records. Direct access includes the ability to fo all except
A.) Examine and analyze all clinical trial records
B.) Verify the clinical trial records
C.) Not assume responsibility during an audit for the confidentiality of the clinical trial
D.) Not assume responsibility during an audit for the confidentiality of the clinical trial records

D.) Not assume responsibility during an audit for the confidentiality of the clinical trial records

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In ICH-GCP quality assurance is defined as
A.) Planned and systemic 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

A.) Planned and systemic action to ensure that the data is generated, recorded and reported according to GCP

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Source documents in a clinical trial refer to all except
A.) Medical notes and pertinent parts of a medical record
B.) Laboratory and radiology records
C.) Pathology reports
D.) Patient diaries and pharmacy records
E.) Site monitoring reports

E.) Site monitoring reports

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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

C.) Audits are generally performed by a regulatory authority whereas monitoring is done by a CRO or sponsor

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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

A.) Declaration of Helsinki

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Which of the following statements about risk in clinical trials does not apply to ICH-GCP
A.) Foreseeable risk should be weighed against anticipated benefits
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

D.) The importance of the objective may in certain circumstances outweigh the risk to the subject

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Which of the following regarding the protocol for a clinical trial is correct
A.) The protocol should reflect sound design is affirmed in DHHS but not ICH
B.) The protocol should reflect sound design is reflected in ICH but not DHHS
C.) The protocol should reflect sound design is affirmed in both ICH and DHHS
D.) There is no reference to sound design in either DHHS or ICH

C.) The protocol should reflect sound design is affirmed in both ICH and DHHS

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The role specifically of medical physician as responsible for medical decisions is affirmed
A.) DHHS only
B.) ICH and DHHS
C.) ICH only
D.) OHRP

B.) ICH and DHHS

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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

C.) ICH, FWA and NIH guidelines

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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

C.) Informed consent should be obtained from every subject

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

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

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Regarding the storage and handling of investigational products ICH
A.) Assigns the responsibility to the principal investigator study
B.) Assigns responsibility to the CRO and study monitor
C.) Does not mention storage and handling
D.) Affirms that handling and storage to be in accordance with GMP

D.) Affirms that handling and storage to be in accordance with GMP

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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 to 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

D.) The IRB should review the quality control measures of a clinical trial

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Agreements between the sponsor and the investigator
A.) Should be in writing as part of the protocol or in 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

A.) Should be in writing as part of the protocol or in separate agreement

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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

D.) Is similar to DHHS in its requirements

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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

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

D.) Current

The statement that continuing review be carried at least once annually is affirmed by A.) ICH only B.) DHHS and ICH only C.) DHHS only D.) DHHS, ICH and FDA

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

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 DHSS C.) ICH describes guidelines for use of an investigational article in an emergency setting D.) ICH states that if consent if subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed

D.) ICH states that if consent if 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

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

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

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 member C.) Should have a non-scientific member D.) Should have a non-affiliated member

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

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

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 A.) DHHS only B.) ICH only C.) DHHS and ICH D.) Not stated exactly in either DHHS or ICH

C.) DHHS and ICH

According to ICH the investigator should promptly report the following to the IRB A.) Deviations from protocol to eliminate immediate hazards B.) Changes in risk in protocol C.) Serious and unexpected adverse drug reactions D.) New information that may affect the safety of subjects E.) All of the above

Deviations from protocol to eliminate immediate hazards, Changes in risk in protocol, Serious and unexpected adverse drug reactions, New information that may affect the safety of subjects

According to ICH the sponsor may request the following from the IRB A.) A copy of the minutes of an IRB meeting B.) IRB correspondence with OHRP C.) Rationale for IRB disapproval D.) Written procedures and membership lists

D.) Written procedures and membership lists

According to ICH the investigator should A.) Demonstrate the potential for recruiting the required number of subjects B.) Have sufficient time and staff to conduct the trial C.) Ensure that the delegated staff be informed about the protocol, duties and product D.) All of the above

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

According to ICH the investigator should A.) Ascertain the reason for withdrawal of a subject B.) Inform a subject's physician about subject participation in a clinical trial C.) Ensure that adequate care is provided for any adverse event experienced by the subject D.) All of the above

Ascertain the reason for withdrawal of a subject, Inform a subject's physician about subject participation in a clinical trial, Ensure that adequate care is provided for any adverse event experienced by the subject

With regard to keeping the IRB informed about the investigator's brochure ICH states that A.) It is the sponsor's responsibility B.) It is the investigator's responsibility C.) It is not needed D.) Updates to the brochure need not be provided

B.) It is the investigator's responsibility

If the investigator implements a change in the protocol to eliminate an immediate hazard the following entities should be informed A.) The IRB B.) The sponsor C.) Regulatory authority if applicable D.) All of the above

The IRB, The sponsor, Regulatory authority if applicable

ICH recommends that responsibility for the investigational product and its accountability A.) The sub-investigator B.) The research coordinator C.) The study monitor D.) The pharmacist

D.) The pharmacist

Drug accountability for the investigational product includes A.) Delivery and inventory at the trial site B.) Use and return of the product C.) Batch, serial numbers and expiration dates D.) All of the above

Delivery and inventory at the trial site , Use and return of the product, Batch, serial numbers and expiration dates

With regard to randomization the investigator should A.) Follow the sponsor's randomization plan B.) Explain to the sponsor any premature unbinding due to an adverse event C.) Both A and B D.) Neither A nor B

Follow the sponsor's randomization plan, Explain to the sponsor any premature unbinding due to an adverse event

According to ICH the informed consent should be A.) Signed but not dated by the subject B.) Sign and dated by the subject only C.) Signed and dated by the subject and the person obtaining consent D.) Witnessed for all consent situations

C.) Signed and dated by the subject and the person obtaining consent

Features of the informed consent in ICH which differ from DHHS guidelines include all of the following except A.) The probability of assignments to each treatment group B.) The risks and benefits of alternative treatments C.) The access to the subject's to the subject's medical records for the monitor, auditor and IRB D.) The anticipated expenses for the subject E.) The number of subjects in the trial

E.) The number of subjects in the trial

The ICH guidelines differ from DHHS guidelines in that they A.) Describe in detail the features of a non-therapeutic trial B.) Describe the process of managing non-therapeutic trials C.) Affirm the need for signed and dated consent and IRB approval of non-therapeutic trials D.) All of the above

Describe in detail the features of a non-therapeutic trial, Describe the process of managing non-therapeutic trials, Affirm the need for signed and dated consent and IRB approval of non-therapeutic trials

The following agreements between sponsor and investigator should be documented in writing A.) Financial arrangements and contracts B.) Protocol agreement document C.) Investigator's brochure receipt and confidentiality document D.) All of the above

Financial arrangements and contracts , Protocol agreement document, Investigator's brochure receipt and confidentiality document

According to ICH the case report forms should be A.) Consistent with source documents B.) Dated, initialed and explained when needed C.) Show the original when corrections are made D.) All of the above

Consistent with source documents, Dated, initialed and explained when needed, Show the original when corrections are made

Serious adverse events in a clinical trial should be reported to the sponsor according to ICH A.) Immediately B.) Within one day C.) Within one week D.) Astime permits

A.) Immediately

When the IRB suspends a clinical trial it should inform A.) The institution B.) The sponsor C.) OHRP D.) All of the above

The institution, The sponsor, OHRP

According to ICH the ultimate responsibility for the quality and integrity of the data rests with A.) The investigator B.) The research coordinator C.) The site monitor and CRO D.) The sponsor

D.) The sponsor

Under ICH the sponsor's responsibilities for electronic data handling includes handling includes all of the following except A.) Accuracy, reliability and consistent performance guided by SOPs B.) Security and backup of the system and access to authorized individuals only C.) Safeguarding of the blinding D.) Part 11 compliance

D.) Part 11 compliance

If the sponsor discontinues clinical development of a drug the records of a clinical trial should be retained for A.) One year B.) Two years C.) Three years D.) Four years

B.) Two years

In 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 B.) Can request retention for at least two years post NDA approval according to FDA guidelines C.) Should notify the investigator in writing when the records are no longer needed D.) All of the above

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

According to ICH the purpose of monitoring is A.) Protect the rights and well being subjects B.) Ensure data are accurate complete and verifiable C.) The conduct of the trial is in agreement with the protocol, GCP and regulatory D.) All of the above

Protect the rights and well being subjects, Ensure data are accurate complete and verifiable, The conduct of the trial is in agreement with the protocol, GCP and regulatory

With regard to the training of monitors ICH states that they should be A.) Appropriately trained with documented qualifications B.) Have needed scientific and clinical knowledge C.) Familiar with the protocol and the consent form D.) All of the above

Appropriately trained with documented qualifications, Have needed scientific and clinical knowledge, Familiar with the protocol and the consent form

In determining the extent of monitoring the sponsor should consider A.) Objective, design, complexity, blinding and size B.) Objective, payments, complexity, blinding, cost C.) Objective, drug supply, payments, complexity, cost D.) Objective, site support, payments, complexity, blinding

A.) Objective, design, complexity, blinding and size

The monitor should A.) Serve as the person who decides on whether a trial should continue at the site B.) List complaints about PO behaviors C.) Train the research coordinator in their daily duties D.) Serve as the main line of communication between the sponsor and the investigator

D.) Serve as the main line of communication between the sponsor and the investigator

With regard to the investigator the monitor should A.) Verify that the investigator has adequate qualifications, resources, facilities and staff B.) Verify whether the investigator meets regularly with staff C.) Verify whether the investigator is delivering on all 1572 commitments D.) Check on the PI's characteristics by talking to staff

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

With regard to drug accountability the monitor should A.) Verify storage items and adequacy of supplies B.) Verify whether eligible patients are getting the drug at the right doses C.) Verify whether subjects are informed and trained about drug use and storage D.) Verify the receipt use, return and disposition of unused drug E.) All of the above

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 and storage, Verify the receipt use, return and disposition of unused drug

The study monitor reviews case report forms during A.) Routine site visits B.) Site initiation visit C.) Study close out visit D.) Pre-study visit

A.) Routine site visits

The study monitor verifies final disposition of unused drug during A.) Routine site visits B.) Site initiation visit C.) Study close out visit D.) Pre-study visit

C.) Study close out visit

The study reviews the protocol and schedule of assessments with the staff during A.) Routine site visits B.) Site initiation visit C.) Study close out visit D.) Pre-study visit

B.) Site initiation visit

The study monitor assesses the investigator's qualification, resources and facilities during A.) Routine site visits B.) Site initiation visit C.) Study close out visit D.) Pre-study visit

D.) Pre-study visit

The study monitor should verify all of the following except A.) Informed consents B.) Receipt and distribution of current copies of the investigator's brochure C.) Delegation of duties to staff D.) Eligibility of enrolled subjects E.) Recruitment rate F.) Case report forms and source documents G.) Record of failed visits and tests and procedures not done H.) The budget for the site and accuracy of financial disclosure

H.) The budget for the site and accuracy of financial disclosure

The site monitor's findings should be summarized in A.) Periodic site monitoring reports B.) E-mails to the investigator C.) Verbal communication with research coordinators D.) Summarized at the close out visit

A.) Periodic site monitoring reports

According to ICH when non-compliance which is serious or persistent is observed the sponsor should A.) Terminate the investigator's participation in clinical trial B.) Inform the IRB C.) Inform the regulatory authorities D.) All of the above

Terminate the investigator's participation in clinical trial, Inform the IRB, Inform the regulatory authorities

According to ICH in multi-center trials the sponsor should A.) Carefully define the responsibilities of the coordinating site principal investigator B.) Delegate monitoring to the coordinating site C.) Allow different standards of compliance depending on the site D.) Permit changes in the CRFs for sites that may suggest these

A.) Carefully define the responsibilities of the coordinating site principal investigator

Regarding protocol and GCP deviations observed by the monitor in a periodic site visit the sponsor may A.) Require that these be reported promptly to the IRB B.) Institute a corrective measure promptly C.) Develop a CAPA plan as needed D.) All of the above

Require that these be reported promptly to the IRB, Institute a corrective measure promptly, Develop a CAPA plan as needed

Regarding withdrawals or dropouts among study subjects, ICH recommends that A.) They be reported to the IRB B.) They be recorded and explained on the appropriate CRFs C.) Notifications be sent to the regulatory authorities D.) Notification be sent to the institution

B.) They be recorded and explained on the appropriate CRFs

ICH guidelines for trial design in protocol preparation includes all except A.) Description of the designs (double-blind, placebo, parallel design) B.) Randomization and blinding C.) Dosage regimens D.) Stopping rules E.) Data recorded directly without source documents F.) IRB communication guidelines

F.) IRB communication guidelines

ICH guidelines for protocol preparation in clinical trials includes all except A.) Inclusion and exclusion criteria B.) Withdrawal and replacement of subjects C.) Schedule of assessments D.) Assessments of safety and efficacy E.) Statistical analysis F.) Publication policy G.) Conflict of interest disclosure

G.) Conflict of interest disclosure

According to ICH statistical analysis section of the protocol should specify whether the following subjects will be included in the analysis except A.) All randomized subjects B.) All dosed subjects C.) All evaluable subjects D.) All eligible subjects E.) All screened subjects

E.) All screened subjects

According to ICH the statistical analysis section of the protocol should include A.) Sample size and power calculations B.) Description of the statistical methods to be used C.) Level of significance for hypothesis testing D.) Criteria for termination of trial E.) All of the above

Sample size and power calculations, Description of the statistical methods to be used, Level of significance for hypothesis testing , Criteria for termination of trial

Description of the investigator's brochure is included in A.) DHHS regulations B.) ICH C.) FDA regulations and guidance D.) OHRP regulations and guidance

B.) ICH

According to ICH the investigator's brochure should include A.) Physical, chemical and pharmaceutical properties and formulations B.) Nonclinical studies including nonclinical pharmacology C.) Pharmacokinetics and toxicology D.) Effects in humans E.) Summary of data and guidance for the investigator F.) All of the above

Physical, chemical and pharmaceutical properties and formulations, Nonclinical studies including nonclinical pharmacology, Pharmacokinetics and toxicology, Effects in humans, Summary of data and guidance for the investigator

The investigator brochure is a living document that is continually updated in a clinical trial to include A.) The latest nonclinical studies B.) Changes in chemistry of the product C.) The latest results from completed clinical trials D.) All of the above

The latest nonclinical studies, Changes in chemistry of the product, The latest results from completed clinical trials

According to ICH the essential documents to be placed on file before the start of clinical trial include all of the following except A.) Investigator's brochure B.) Protocol and other sponsor/CRO agreements C.) Informed consents D.) Recruiting and advertising information E.) Financial aspects and insurance information F.) IRB approvals G.) CV for investigator and sub investigator H.) Randomization and decoding information I.) Site initiation report and pre-trial site suitability assessments J.) Forms 1571 and 1572

J.) Forms 1571 and 1572

According to ICH the additional documents to be placed on file during clinical trial include A.) Enrollment and screening logs B.) Annual reports to the IRB C.) Signature sheet/ delegation log D.) Drug accountability records E.) All of the above

Enrollment and screening logs, Annual reports to the IRB, Signature sheet/ delegation log, Drug accountability records

According to ICH the additional documents to be included on file after completion of the trial are A.) Final close out study monitoring report B.) Final report to IRB C.) Clinical study report to document results and interpretation of trial D.) All of the above

Final close out study monitoring report, Final report to IRB, Clinical study report to document results and interpretation of trial

According to ICH the following statements about the involvement of a CRO in clinical trial are correct: A.) A sponsor may transfer any or all of the trial related duties and functions to a CRO B.) The CRO should implement quality assurance and quality control C.) The delegated CRO responsibilities should be specified in writing D.) All of the above

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, The delegated CRO responsibilities should be specified in writing

It would be usual practice for a CRO to assume all of the responsibilities outlined below except A.) Collection of forms 1572 from the PI B.) Preparation and distribution of regulatory binder C.) Site initiation and site close out visits D.) Monitoring data integrity and quality E.) Reviewing the delegation of authority log F.) Pretrial investigator and facilities assessment G.) Preparation of the investigator's brochure and the updates H.) Distribution of the protocol and protocol updates

G.) Preparation of the investigator's brochure and the updates

It would be usual practice for a CRO to assume all of the responsibilities outlined below except A.) Implementation of randomization schema B.) Review of all regulatory aspects pertaining to the laboratory C.) Review of all regulatory aspects of drug accountability D.) Implementing and monitoring payments to subjects E.) Collection of SAE reports and forwarding to sponsor F.) Protocol preparation and DSMB management

F.) Protocol preparation and DSMB management

The Medical Safety Officer at the sponsor carries out which of the duties listed below? A.) Providing medical advice during clinical trial B.) Assessing medical waivers of eligibility C.) Review of SAEs and continuance of subjects on the study D.) All of the above

Providing medical advice during clinical trial, Assessing medical waivers of eligibility, Review of SAEs and continuance of subjects on the study

Which of the duties listed below are typically carried out by the sponsor and not the CRO? A.) Protocol preparation and updates B.) Investigator brochure preparation and updates C.) Correspondence and interaction with the FDA D.) Manufacture and supply of investigational drug E.) Preparation of the pharmacy manual F.) Management of the DSMB G.) All of the above

Protocol preparation and updates, Investigator brochure preparation and updates, Correspondence and interaction with the FDA, Manufacture and supply of investigational drug, Preparation of the pharmacy manual, Management of the DSMB

If the investigator terminates a trial at the site without prior approval from the sponsor should inform the following in writing of this decision A.) IRB B.) Institution C.) Sponsor D.) All of the above

IRB, Institution, Sponsor

Regarding the issuance of a final report by the investigator the ICH advises that the investigator should A.) Inform the institution B.) Provide the IRB with a summary of the trial's outcome C.) Provide regulatory authorities with any reports that may be required if applicable D.) All of the above

Inform the institution, Provide the IRB with a summary of the trial's outcome, Provide regulatory authorities with any reports that may be required if applicable

According to ICH for an investigator to be eligible to conduct a clinical trial he should be A.) Qualified by education, training and experience B.) Meet the qualification specified by regulatory authorities and the IRB C.) Should provide documentary evidence of his qualifications to the sponsor and the IRB D.) All of the above

Qualified by education, training and experience, Meet the qualification specified by regulatory authorities and the IRB, Should provide documentary evidence of his qualifications to the sponsor and the IRB

ICH advises that the following individuals may be utilized in trial design except A.) Biostatisticians B.) Clinical pharmacologists C.) Physicians D.) Financial analyst

D.) Financial analyst

ICH advises that in terms of compensation for claims arising during a clinical trial the A.) Not provide any assurances to the site B.) Assume negligence on the part of the PI C.) Provide insurance or indemnify the investigator D.) Compensate only life-threatening emergencies on the part of the subject

C.) Provide insurance or indemnify the investigator

Regarding the sponsor's audits of a clinical trial ICH advises all of the following except A.) They be in written form, dated and signed B.) Include a summary of what was reviewed, deviations and deficiencies and actions to be taken C.) Review and follow up of the report with the sponsor D.) Punitive actions to be taken against the PI or study coordinator

D.) Punitive actions to be taken against the PI or study coordinator

Regarding the sponsor's audits of a clinical trial ICH advises all of the following except A.) Written procedures to be followed in the event of an audit B.) The audit plan takes into account the complexity and importance of the clinical trial C.) Where applicable an audit certificate should be issued D.) Send the audit report to the IRB

D.) Send the audit report to the IRB

An adverse drug reaction is A.) A congenital birth defect caused by a drug B.) An event described in the adverse drug reaction tabulation at the FDA C.) A repeat hospitalization caused by progression of disease D.) A noxious and unintended response to a drug at any dose

D.) A noxious and unintended response to a drug at any dose

A response to a medical product in the context of an adverse drug reaction is best defined as A.) An event documented in the medical record B.) A death C.) A causal relationship between a drug and an adverse event is possible D.) An event that occurs in the time frame of drug administration

C.) A causal relationship between a drug and an adverse event is possible

A possible relationship of an adverse drug reaction to a drug may be defined as one A.) Reported by the patient B.) Suspected by the Principal Investigator C.) An event that is discontinued when the drug is discontinued D.) An event in which the relationship cannot be ruled out

D.) An event in which the relationship cannot be ruled out

An adverse event is defined as A.) A mild clinical event not associated with hospitalization B.) An episode that interrupts a daily activity C.) An event that requires a doctor's visit D.) A medical occurrence which may not be causally related to a drug

D.) A medical occurrence which may not be causally related to a drug

Which of the following is true? A.) All adverse events are adverse drug reactions B.) All adverse drug reaction may be classified as adverse events C.) An adverse event is never classified as an adverse drug reaction D.) An adverse drug reaction excludes mild adverse events

B.) All adverse drug reaction may be classified as adverse events

An adverse event is one which occurs A.) Within ten days of drug administration B.) An event which may occur after study treatments have been completed C.) An event which occurs immediately after drug administration D.) An event temporally associated with drug use which may or may not be drug related

D.) An event temporally associated with drug use which may or may not be drug related

Steps to reduce bias in clinical trial include A.) Blinding B.) Masking C.) Randomization D.) All of the above

Blinding, masking, raandomization

Double blind study design entails that the following are unaware of the treatment assignment A.) Subject B.) Investigator C.) Monitor D.) All of the above

Subject, investigator, monitor

In a single blind trial the person unaware of the treatment assignment is A.) The subject B.) The investigator C.) The monitor D.) The data analyst

A.) The subject

The purpose of a double blind design is to ensure A.) Deceive the subject B.) Reduce the bias on the part of the investigator C.) Reduce the bias on the part of the subject D.) Reduce bias on the art of subject and investigator

D.) Reduce bias on the art of subject and investigator

The types of bias on the part of the investigator that are reduced or eliminated by blinding may include A.) Making changes in the protocol eligibility criteria that may favor the sponsor B.) Data falsification and fabrication C.) Lack of reporting of protocol deviations and serious adverse events D.) All of the above

Making changes in the protocol eligibility criteria that may favor the sponsor, Data falsification and fabrication, Lack of reporting of protocol deviations and serious adverse events

The bias on part of a subject in a clinical trial would best be represented by A.) Complaints to OHRP regarding the IRB B.) Noncompliance with the visitation schedule C.) Altered behavior which may subvert the objective of the trial D.) Non-authorized variation in the drug dosing schedule

C.) Altered behavior which may subvert the objective of the trial

The termCRO stands for A.) Certified research organization B.) Certified research officer C.) Contract research official D.) Contract research organization

D.) Contract research organization

Good clinical practice represents all of the features below expect A.) Is a standard for the design conduct performance of clinical trial B.) A standard for auditing, recording , monitoring and reporting of a clinical trial C.) Assurance that the data are accurate and credible D.) Assurance that the rights, integrity and confidentiality of trial subjects is protected E.) Represents a mandatory regulatory guidance for clinical trial management

E.) Represents a mandatory regulatory guidance for clinical trial management

A data and safety monitoring board does all of the following except A.) Supports SAE review by the IRB B.) Assesses progress of a clinical trial C.) Monitors all aspects of data safety for a clinical trial D.) Recommends to the sponsor whether a trial should be continued, modified or stopped

A.) Supports SAE review by the IRB

An inspection of a clinical trial is all of the following except A.) Usually performed by a regulatory authority B.) Consists of a review of documents, facilities, records and any other resources at the site C.) May occur at the site or at the sponsor or CRO location D.) Is usually integrated into the monitoring schedule

D.) Is usually integrated into the monitoring schedule

An institution (medical) is defined as a site for clinical trials and include A.) Any public or private entity or agency B.) A medical facility C.) A dental facility D.) All of the above

Any public or private entity or agency, a medical facility, a dental facility

An impartial witness is all of the following except A.) A person who cannot be unfairly influenced B.) Attends the informed consent conference when the subject or LAR cannot read C.) Reads any written information supplied to the subject D.) Is usually certified by the institution

D.) Is usually certified by the institution

A monitor ensures that a clinical trial is being performed as specified in A.) The protocol B.) Standard operating procedures C.) Good Clinical Practice and other regulatory requirements D.) All of the above

The protocol, Standard operating procedures, Good Clinical Practice and other regulatory requirements

A non clinical study is one which is all of the following except A.) Includes all animal studies B.) Any non human study C.) Usually precedes human studies D.) May apply to human studies with high risk and no benefit

D.) May apply to human studies with high risk and no benefit

Under ICH GCP all of the following apply to a legally authorized representative (LAR) A.) Is an individual authorized to consent on behalf of a trial subject B.) Juridical or other body authorized under applicable law to consent on behalf of a trial subject C.) Often consents in situations where the trial subject is unable to consent for himself D.) Is authorized to make financial decisions on behalf of the trial subject if hospitalized

D.) Is authorized to make financial decisions on behalf of the trial subject if hospitalized

Randomization entails all of the following except A.) Use of a computer generated number system B.) Use of an interactive voice recognition system C.) Involves assignments to treatment and control groups D.) Is often decided by a coin toss

D.) Is often decided by a coin toss

Under ICH a vulnerable subject may include all of the following except (Choose all that apply) A.) Medical pharmacy, dental or nursing students B.) Members of the armed forces C.) Subordinate hospital or laboratory personnel D.) Persons kept in detention E.) Pregnant women F.) Fetuses and neonates G.) Children H.) Unemployed, impoverished or homeless persons I.) Nomads, refugees J.) The elderly K.) Ethnic minority groups L.) Uneducated or illiterate individuals

Pregnant women, fetuses and neonates, the elderly, Uneducated or illiterate individuals

Central features of a vulnerable subject in ICH GCP include all except A.) Subject influenced by the benefits of participation B.) Subjects influenced by a retaliatory response by a senior member of hierarchy C.) Subjects of an ethnic minority group D.) Subjects enrolled in more than one clinical trial at the same time

D.) Subjects enrolled in more than one clinical trial at the same time

Responsibility for the investigational product rests with the A.) Monitor B.) Sponsor C.) CRO D.) Investigator

B.) Sponsor

Regarding the use of the investigational product the investigator should A.) Maintain records that the subjects were provided with the doses stated in the protocol B.) Ensure that the drug was used only as described in the protocol C.) Should ensure that the drug use is explained to the subject and compliance is verified D.) All of the above

Maintain records that the subjects were provided with the doses stated in the protocol, Ensure that the drug was used only as described in the protocol, Should ensure that the drug use is explained to the subject and compliance is verified

If the subject or the LAR is unable to read the informed consent A.) The subject should not be considered for enrollment B.) Written permission should be obtained from the IRB prior to enrollment C.) A family member should be recruited to explain the consent D.) An impartial witness should be present

D.) An impartial witness should be present

The primary role of the witness is to ensure that A.) Provide emotional support to the subject B.) Satisfy the IRB that the informed consent process is adequate C.) Ensure that the information was understood and consent freely given by the subject D.) Verify that signatures and dates on the consent are adequate

C.) Ensure that the information was understood and consent freely given by the subject

The essential documents for a clinical trial should be retained for A.) At least two years after discontinuation of clinical development of the drug B.) For a period of longer than two years if applicable regulatory requirements demand it D.) All of the above

At least two years after discontinuation of clinical development of the drug, For a period of longer than two years if applicable regulatory requirements demand it

Premature termination of clinical trial should be reported by the investigator A.) The research subjects B.) The regulatory authority if applicable C.) The IRB D.) All of the above

The research subjects, The regulatory authority if applicable, The IRB

If the IRB suspends a clinical trial the investigator should report it to A.) The sponsor B.) The institution C.) The regulatory authority D.) Both a and b

The sponsor, the institution

The final report of the investigator should be provided to A.) The IRB B.) The regulatory authority C.) Both a and b D.) The institution

The IRB, The regulatory authority

Individuals utilized by the sponsor for all stages of the clinical trial process may include all of the following except A.) Biostatisticians B.) Clinical pharmacologists C.) Physicians D.) Trial subjects where appropriate

D.) Trial subjects where appropriate

With regard to electronic trial data the sponsor should ensure all of the follow except A.) The EDC vendor is approved by the IRB B.) The data changes are documented C.) There is no deletion of entered data D.) An audit, data and edit trials are maintained

A.) The EDC vendor is approved by the IRB

For identification of all subjects data the sponsor should A.) Use the medical record number B.) Use the name C.) Use an identification code D.) Use a social security number or driver's license number

C.) Use an identification code

Before entering an agreement with the investigator/institution the sponsor should provide A.)The IRB with the protocol B.) The investigator/institution with the protocol only C.) The investigator/institution with investigator's brochure D.) The investigator/institution with protocol and the investigator's brochure

D.) The investigator/institution with protocol and the investigator's brochure

Delegation of authority to the staff at the site level should be A.) Done independently by the investigator B.) Approved by the IRB C.) Defined established and allocated by the sponsor D.) Delegated to the CRO

C.) Defined established and allocated by the sponsor

With regard to liability claims that may arise against the investigator/institution the sponsor should A.) Provide indemnification B.) Provide insurance where possible C.) Specify compensation for trial subjects in the event of trial related injury D.) All of the above

Provide indemnification, Provide insurance where possible, Specify compensation for trial subjects in the event of trial related injury

The sponsor should ensure that in planning for a clinical trial the sponsor should ensure all of the following except A.) Sufficient safety and efficacy data is available from non clinical studies B.) Pilot studies in human subjects have been performed C.) That the drug will be safe in pregnant women and children D.) Data to support route, dosage and duration of treatment is available

C.) That the drug will be safe in pregnant women and children

With regard to access to medical records during clinical trials A.) The subject should consent in writing to medical record access B.) Access should be guaranteed for monitoring, audits, IRB review and regulatory inspection C.) Access should be in accord with prevailing federal and state laws D.) All of the above

The subject should consent in writing to medical record access, Access should be guaranteed for monitoring, audits, IRB review and regulatory inspection, Access should be in accord with prevailing federal and state laws

The monitor should ensure all of the following except (check all that apply) A.) Informed consent was obtained before subject participation B.) The investigator receives the investigator's brochure C.) Protocol procedures are performed is specified in the protocol's schedule of assessments D.) Only eligible subjects are enrolled E.) CRFs are accurate and supported by sourced documents F.) Participate in the meetings between the investigator and staff G.) Contribute to the investigator's recruitment efforts H.) Failed visits, test and procedures not performed are reported on CRFs I.) Adverse events are reported to the IRB and sponsor in timely fashion

F.) Participate in the meetings between the investigator and staff

The monitoring report should include A.) Name of the investigator B.) Significant findings, deviations and deficiencies C.) Actions needed to secure compliance D.) All of the above

Name of the investigator, Significant findings, deviations and deficiencies, Actions needed to secure compliance

With regard to access to the sponsor's audit report by regulatory authority ICH advises A.) Regulatory authority should not routinely request access to the audit report B.) Require the audit report to be part of he study binder C.) Ask to see the internal audit reports prior to commencing their audits D.) Record the absence of an internal audit report a deficiency

A.) Regulatory authority should not routinely request access to the audit report

Toxicological effects in the investigator's brochure should include A.) Carcinogenicity B.) Irritancy C.) Reproductive toxicity D.) Genotoxicity and mutagenicity E.) All of the above

Carcinogenicity, Irritancy, Reproductive toxicity, Genotoxicity and mutagenicity

The investigator's brochure should include all of the following except A.) Marketing experience in foreign countries B.) Summary and data guidance for the investigator C.) Discussion of published reports on related products D.) Potential costs of the clinical trial

D.) Potential costs of the clinical trial

Which of the following would not be classified as an SAE? A.) An anaphylactic event which needed an emergency room visit B.) An acute renal failure which is resulted in an increased hospitalization stay of one day C.) A stroke which occurred during the clinical trial D.) Severe hallucinations caused by the ingestion of a recreational drug

D.) Severe hallucinations caused by the ingestion of a recreational drug

In response to new preclinical studies a sponsor revises the investigator's brochure which leads to changes in the inclusion and exclusion criteria and informs the PI of these changes. The PI or CRC should A.) File an amendment to the IRB detailing the change B.) Make revisions in the informed consent C.) Reconsent existing enrolled subjects D.) All of the above

File an amendment to the IRB detailing the change, Make revisions in the informed consent, Reconsent existing enrolled subjects

The person who the subject should contact for research subject rights is A.) The person noted in the consent form for such contact B.) A person other than the principal investigator C.) Usually an IRB appointed research subject advocate described in the consent form D.) All of the above

A.) The person noted in the consent form for such contact

The person who should be contacted regarding a medical emergency experienced at home by a clinical trial subject is A.) Always the principal investigator B.) The sponsor's medical safety officer C.) The research coordinator D.) The person designated for contact for medical matters on the consent form

D.) The person designated for contact for medical matters on the consent form

The best way for a PI to inform a subject about a placebo in a double blind trial includes all of the following except A.) There is a fifty percent chance that you may be in a group that does not receive the investigational drug B.) Because of the restrictions of the study I cannot tell you if you are in the group receiving drug or sugar pill C.) You will receive the same attention regardless of whether you are receiving a drug or a sugar pill D.) You need not concern yourself about whether you are receiving the drug or a sugar pill as we cannot tell you if the clinical trial has had any beneficial effect

D.) You need not concern yourself about whether you are receiving the drug or a sugar pill as we cannot tell you if the clinical trial has had any beneficial effect

According to ICH all of the following are essential documents except A.) Delegation of authority forms B.) Certificates of analysis for new batches of investigational drugs C.) Normal values for the analytes being tested D.) Conflict of interest information for core team members

D.) Conflict of interest information for core team members

A clinical trial in which the only the research pharmacist knows the identity of the test article being given to subjects is a A.) Single blind trial B.) Double blind trial C.) Open label trial D.) Crossover design trial

B.) Double blind trial

A subject on a clinical trial for GI reflux disease experiences several bowel movements and is hospitalized for dehydration. He has been on the test drug for three weeks and the event is thought by the PI to be related to the test drug. The event should be reported in all of the following ways except A.) As a serious adverse event to the IRB B.) To the sponsor on the appropriate CRF C.) By the sponsor to the regulatory agency D.) To the family physician for symptom management

D.) To the family physician for symptom management

An SAE experienced by a subject on a test drug for a clinical trial should be reported to A.) Immediately to the sponsor B.) To the regulatory agency within 7 calendar days C.) To the IRB usually in five days or sooner depending on institutional policy D.) All of the above

Immediately to the sponsor, To the regulatory agency within 7 calendar days, To the IRB usually in five days or sooner depending on institutional policy

In consenting an adult illiterate subjects who cannot read or write english the consent process should include A.) Reading the consent form to the subject B.) Having the subject make a mark "X" on the subject signature line C.) Have an impartial witness present D.) All of the above

Reading the consent form to the subject, Having the subject make a mark "X" on the subject signature line , Have an impartial witness present

A medically competent subject who has recently undergone physical injury in an accident to his writing hand signs the consent form with an "X" the consent process should include A.) An impartial witness B.) The signature of a legal guardian C.) A medical counselor D.) The signature of a family member

B.) The signature of a legal guardian

About 15 subjects were enrolled in a clinical trial. The trial is most likely A.) Phase I B.) Phase III C.) Phase III D.) Phase IV

A.) Phase I

A clinical trial requires five CT scans in the period of one year. For the disease condition only one CT scan per year is indicated. The situation requires A.) The radiation safety committee evaluation and approval prior to IRB approval B.) Statement about radiation risk in the consent form C.) A consideration of an alternative imaging technique if possible D.) All of the above

The radiation safety committee evaluation and approval prior to IRB approval, Statement about radiation risk in the consent form, A consideration of an alternative imaging technique if possible

A subject being screened for a clinical trial of a drug for allergic rhinitis presents with a heart rate of 100 beats per minute. Tachycardia is not an exclusion criteria for the study. The CRC should A.) Ask the sponsor's medical safety officer if the subject should be enrolled B.) Do a repeat measurement of heart rate in two weeks or more to see if the symptoms is repeatable C.) Ask the subject if he has experienced any symptoms of a rapid heart beat D.) All of the above

Ask the sponsor's medical safety officer if the subject should be enrolled, Do a repeat measurement of heart rate in two weeks or more to see if the symptoms is repeatable, Ask the subject if he has experienced any symptoms of a rapid heart beat

During the course of a clinical trial the CRC notices that the Hct values have been consistently low in several subjects. Upon further investigation it was discovered that the lab assistant was storing the samples under his desk and sending the entire batch for analysis once every week. The CRC should A.) Immediately inform the PI B.) File a protocol deviation with the IRB C.) Inform the sponsor D.) Arrange to have the lab assistant retrained or disciplined E.) Initiate a CAPA plan F.) All of the above

Immediately inform the PI, File a protocol deviation with the IRB, Inform the sponsor, Arrange to have the lab assistant retrained or disciplined, Initiate a CAPA plan

A CRC has scheduled a first visit for a subject for an IRB approved study. When the patient arrives the CRC notices that the IRB approval letter is missing a date. The CRC should do all of the following except A.) Reschedule the visit B.) Contact the IRB and ask for a dated letter C.) Inform the PI D.) File an unanticipated event report with the IRB

D.) File an unanticipated event report with the IRB

A phase I oncology study for lymphoma in children should enroll A.) Healthy adults B.) Healthy children C.) Children with any known cancer D.) Children with lymphoma who have failed standard treatment

D.) Children with lymphoma who have failed standard treatment

The features of a source document should include their being A.) Attributable and legible B.) Contemporaneous C.) Original and accurate D.) All of the above

Attributable and legible, Contemporaneous, Original and accurate

In conducting an audit of source documents the auditor would look for A.) Original entries that were clearly visible including alterations B.) Traceable or attributable documents C.) An audit trail of access to or alteration of the source documents D.) All of the above

Original entries that were clearly visible including alterations, Traceable or attributable documents, An audit trail of access to or alteration of the source documents

For a CRC to file SAE reports to the IRB it would be advised that A.) The CRC is a qualified physician B.) The CRC is delegated this function in the investigators delegation log C.) This function be approved by the sponsor and the IRB D.) All of the above

The CRC is a qualified physician, The CRC is delegated this function in the investigators delegation log, This function be approved by the sponsor and the IRB

Clinical trial records should be preserved for at least A.) Two years post marketing approval B.) Two years post study closure C.) Four years after the filing of marketing application D.) As long as sponsor wants

A.) Two years post marketing approval

If a sponsor finds in an audit an action of the investigator which compromises human subject protection or reliability of the trial the sponsor should A.) Immediately terminate the investigator's involvement B.) Notify the regulatory agency C.) Notify the IRB D.) Conduct a root cause analysis

D.) Conduct a root cause analysis

If a potential subject cannot speak or write english and an informed consent conference has to be held the investigator should A.) Request the appropriate foreign language form from the sponsor B.) Follow IRB procedures including the use of a consent short form of the foreign language C.) Utilize a qualified and certified interpreter for the communication of the foreign language consent form D.) All of the above

Request the appropriate foreign language form from the sponsor, Follow IRB procedures including the use of a consent short form of the foreign language, Utilize a qualified and certified interpreter for the communication of the foreign language consent form

A patient with a history of migraines in a clinical trial reports a migraine episode of greater frequency than usuals the investigator should A.) Report the event as an SAE to the IRB B.) Notify the sponsor of an SAE and do so promptly C.) Neither report nor record the event D.) Record and report the episode as an adverse event to the sponsor

D.) Record and report the episode as an adverse event to the sponsor

An SAE is a medical event associated with A.) Death B.) Life threatening event C.) Hospitalization or increased hospitalization stay D.) All of the above

Death, Life threatening event, Hospitalization or increased hospitalization stay

At a site initiation visit the sponsors CRA reviews A.) The protocol B.) The schedule of assessments and associated CRFs C.) The site SOPs D.) All of the above

The protocol, The schedule of assessments and associated CRFs, The site SOPs

The monitor is responsible for A.) Verifying conflict of interest information on the part of the investigator B.) Facilitating recruitment at the site C.) Assisting the local CRC in scheduling patients D.) Source document verification

D.) Source document verification