According to ICH GCP Payments to a subject should be: 1. Prorated and not wholly contingent on completion of the trial by the subject 2. Payed in full no matter what

1. Prorated and not wholly contingent on completion of the trial by the subject

According to ICH GCP The investigator should submit written summaries of the trial status to the IRB/EIC. 1. Monthly 2. Annually 3. Every Six Months 4. Annually, or more frequently if requested by the IRB/IEC.

4. Annually, or more frequently if requested by the IRB/IEC.

According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how frequently? 1. Once Yearly 2. Every 3 months 3. At intervals appropriate to the degree of risk to human subjects, but at least once per year.

3. At intervals appropriate to the degree of risk to human subjects, but at least once per year.

According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how often? 1. Once Yearly 2. Every 3 months 3. At intervals appropriate to the degree of risk to human subjects, but at least once per year.

3. At intervals appropriate to the degree of risk to human subjects, but at least once per year.

GCP Study 3 Flashcards by John Doe

According to ICH GCP addendum the sponsor should develop a systematic, prioritized what type of approach to monitoring clinical trials?

A - Risk Based
B - Fast
C - Slow
D - None

A - Risk-based

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Acrrcording to ICH GCP Adverse and/or laboratory abnormalities identified in the protocol as critical evaluations should be reported to the ?

A-Sponsor
B-CRC
C-CRA
D-Investigator
E-Other

A - Sponsor

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According to ICH GCP adverse events, concomitant medications, and intercurrent illnesses are reported in accordance with what on the eCRFs?

A - In accordance with Protocol
B - In accordance with GCP
C - In accordance with Helsinki agreement

A - In accordance with Protocol

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According to ICH GCP All serious events (SAEs) should be reported immediately to the ?

A - Sponsor
B - investigator
C - Monitor
D - IRB

A - Sponsor

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According to ICH GCP an IRB/IEC should safeguard the ?

A - Rights, Safety and well-being of all trial subjects
B - The sponsor
C - The Investigator
D - Insurance

A - Rights, Safety and well-being of all trial subjects

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According to ICH GCP, contract is ( ????), dated and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters.

A - Verbal
B - Written
C - Emailed
D - Audio

B - Written

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According to ICH GCP double blind usually refers to the ( ??????) being unaware of the treatment assignment (s)

A - Sponsor
B - Investigator
C - Monitor
D - Data Analyst (s)
E - subject(s), investigator (s), monitor, and in some cases data analyst(s)

E - subject(s), investigator (s), monitor, and in some cases data analyst(s)

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

A - 1 Year
B - 2 Years
C - 3 Years
D - 5 Years
E - 10 Years

C - 3 Years

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According to ICH GCP how frequently should staff be trained in GCP?

A - Every Year
B - There is no Specific Requirements
C - Every 2 Years

B - There is no Specific Requirements

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According to ICH GCP how much source data verification (SDV) should be done?

A - 100 %
B - 50 %
C - There is no specific requirement

C - There is no specific requirement

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According to ICH GCP how soon should serious adverse events (SAEs) be reported by the investigator?

A - Every Month
B - Every Day
C - Every Week
D - Immediately to the sponsor

D - Immediately to the sponsor

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According to ICH GCP if centralized monitoring is used what else should be in place?

A - Nothing
B - Extensive written guidance, investigator training and meetings

B - Extensive written guidance, investigator training and meetings

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According to ICH GCP if the answer to a question is Investigator, then what could the question be?

Who has responsibility for the investigational product accountability at the trial site?
Who should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period?
Who is responsible for the ongoing safety evaluation of the investigational product?

1 and 2 only

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According to ICH GCP if the trial is prematurely terminated or suspended for any reason, the investigator/instituation should do which of the following as well as notifying IRB/EIC and local regulatory authorities.

Return all IMP to the sponsor immediately
Contact all subjects to ensure immediate return of all IMP
Promptly inform the trial subject
Should assure appropriate therapy and treatment follow-up for the subjects

3 & 4 Only

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According to ICH GCP Monitors should be appointed by the sponsor. These monitors should be appropriately trained, and should have what else?

A - The scientific and/or clinical knowledge needed to monitor the trial adequately
B - Updated CV
C - Mathematical knowledge
D - Common Knowledge

A - The scientific and/or clinical knowledge needed to monitor the trial adequately

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According to ICH GCP Non-Therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled:

The negative impact on the subject’s well-being is minimized and low
The trial is not prohibited by law
The foreseeable risks to the subjects are low
4.The objectives of he trial can not be met by means of a trial in subjects who can give informed consent personally.

1, 2, 3 and 4 (All of them)

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According to ICH GCP Payments to a subject should be:

Prorated and not wholly contingent on completion of the trial by the subject
Payed in full no matter what

Prorated and not wholly contingent on completion of the trial by the subject

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According to ICH GCP section 5.2 Contract Research Organization, Any Trial Related duty and function that is transferred to and assumed by a CRO shield be specified in:

Email
Writing
Phone call

Writing

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According to ICH GCP Section 5.8 Compensation to Subjects and Investigators which of the following is not true?

A) Sponsor should provide insurance
B) Sponsor should indemnify investigator against claims arising from negligence
C) Sponsor should indemnify investigator against claims arising from malpractice
D) Both A and B

D) Both A and B

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

A) Traceable
B) Hidden
C) Clear

A) Traceable

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According to ICH GCP The investigator should be thoroughly familiar with the appropriate use of the investigational product(s) as described in the:

Protocol, investigator brochure, and in the product information
Email
Study documentation

Protocol, investigator brochure, and in the product information

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

Monthly
Annually
Every Six Months
Annually, or more frequently if requested by the IRB/IEC.

Annually, or more frequently if requested by the IRB/IEC.

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According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how frequently?

Once Yearly
Every 3 months
At intervals appropriate to the degree of risk to human subjects, but at least once per year.

At intervals appropriate to the degree of risk to human subjects, but at least once per year.

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According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how often?

Once Yearly
Every 3 months
At intervals appropriate to the degree of risk to human subjects, but at least once per year.

At intervals appropriate to the degree of risk to human subjects, but at least once per year.

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According to ICH GCP the IRB/IEC should promptly notify in writing: A) It's trial related decisions/opinion B) The reasons for its decisions/opinions C) Procedures for appeal of its decisions/opinions D) All of the above

D) All of the above

According to ICH GCP the quality management system should use a ???? approach. 1) tough 2) risk-based 3) minor 4) easy understood

2) risk-based

According to ICH GCP what action should the sponsor take in the event of non-compliance by investigational site staff? A) Prompt action by the sponsor to secure compliance B) Routine Checkups C) Yearly checkup d) Every Six Months Checkup

A) Prompt action by the sponsor to secure compliance

According to ICH GCP the sponsor should take steps to ensure that the investigational product(s) are stable over what? A) The trial period B) Period of use C) All the time

B) Period of use

According to ICH GCP what always resides with the sponsor? A) Everything B) Ultimate responsibility for the quality and integrity of the trial data. C) No responsibility

B) Ultimate responsibility for the quality and integrity of the trial data.

According to ICH GCP, what is addendum in monitoring? A) a document B) Monitoring Plan C) just a section

B) Monitoring Plan

According to ICH GCP what is the purpose of updates of medical/laboratory tests? A) To check patient data B) To ensure health C) To document that tests remain adequate throughout the trial period

C) To document that tests remain adequate throughout the trial period

According to ICH GCP what Is the sponsor responsibility regarding supply of investigational Products? A) no responsibility B) To supply the Investigational Product (IP) to the investigator C) To ensure investigator has its own investigational Product (IP)

B) To supply the Investigational Product (IP) to the investigator

According to ICH GCP what should the sponsors provide to investigators and/or the investigators designated representatives concerning making corrections to the eCRF? A) Documentation B) Guidance C) Instructions

B) Guidance

According to ICH GCP when should the sponsor update the Investigator Brochure? A) Monthly B) Yearly C) As significant new information becomes available

C) As significant new information becomes available

According to ICH GCP where advertisements for subject recruitment should be filed? A) TV B) Radio C) The investigator file only

C) The investigator file only

According to ICH GCP where would you file the Signed Informed Consent Forms? A) Investigator File B) Sponsor File C) Monitoring File

A) Investigator File

According to ICH GCP which document describes the strategy, methods, responsibilities, and requirements for monitoring the trial A) Protocol B) Monitoring Plan C) SDV Plan

B) Monitoring Plan

According to ICH GCP which documents document the existence of the subject and substantiate integrity of trial data collected? A) Written Documents B) Source Documents C) Email Documents

B) Source Documents

According to ICH GCP which of the following documents should be reviewed by the IEC/IRB? 1. The Investigator's Brochure 2. The Investigator's CV 3. The subject compensation 4. Payment to the Investigator

1, 2 and 3 only

According to ICH GCP which of the following is NOT one of the procedures generally included in protocols regarding Subject Withdrawal Criteria? A) How to define withdrawals due to lack of efficacy, safety or subject no longer wanting to continue B) None C) All

A) How to define withdrawals due to lack of efficacy, safety or subject no longer wanting to continue

According to ICH GCP which of the following is not part of the sponsor's responsibility for determining for Investigational product: A) storage temperature B) storage locations C) storage conditions D) storage times

B) storage locations

According to ICH GCP which of the following lists are required for clinical trials to be compliant with ICH GCP? 1) A list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties. 2) A list of IRB/IEC members and their qualifications. 3) A list of the individuals who are authorized to make data changes.

All of them.

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

1 and 2

According to ICH GCP who is responsible for destruction of Investigational Product(s)? 1) Sponsor 2) Investigator 3) Monitor

1) Sponsor

According to ICH GCP Who is responsible for selecting Investigator/Institution? A) Sponsor B) Investigator C) Monitor

A) Sponsor

According ICH GCP who is responsible for training the investigator in GCP? A) Sponsor B) Monitor C) There is no specification

C) There is no specification

According to ICH GCP who is responsible for verifying that storage times and conditions for IMP are acceptable? A) Sponsor B) Monitor C) Investigator

B) Monitor

According to ICH GCP who should be responsible for the medical care of trial subjects at site? 1) Their own doctor 2) Nurse 3) A qualified physician (or dentist, when appropriate ) who is an investigator or a sub-investigator for the trial.

3) A qualified physician (or dentist, when appropriate ) who is an investigator or a sub-investigator for the trial.

According to ICH GCP who should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions? A) Sponsor B) Investigator C) Monitor

B) Investigator

According to ICH GCP, ???? is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons? A) SIte monitoring B) Centralized monitoring C) Office Monitoring

B) Centralized monitoring

According to ICH GCP, Documentation that allows reconstruction of the course of events is: A) Audit Trail B) Source Docs C) Reports

A) Audit Trail

According to ICH GCP, the definition of Sponsor-Investigator is: An individual who ??? alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. A) both initiates and conducts B) does C) does not

A) both initiates and conducts

According to ICH GCP, the financial aspects of the trial should be documented in an agreement between: A) Sponsor and Investigator B) Sponsor and ERB C) Sponsor and CRA

A) Sponsor and Investigator

According to ICH GCP, where should subject enrollment log be filed? A) Sponsor File Only B) Investigator File only

B) Investigator File only

According to Principles of ICH GCP, A trial should be conducted in compliance with the protocol that has received prior approval/favourable opinion from: A) Institutional Review Board B) Sponsor C) Investigator

A) Institutional Review Board

According to Principles of ICH GCP, a trial should be initiated and continued if: A) Anticipated benefits justify the risk B) Only if patients can be saved C) Only if there is something to be tested

A) Anticipated benefits justify the risk

According to Principles of ICH GCP, What should be obtained from every subject prior to clinical trial participation? A) Freely Given Informed Consent B) Nothing C) Verbal agreement

A) Freely Given Informed Consent

According to section 5 of ICH GCP, Sponsor, when should the monitor submit a written report to the sponsor? A) after each trial site visit or after each trial related communication B) Monthly C) Yearly

A) after each trial site visit or after each trial related communication

According to section 6 of ICH GCP what are the procedures generally included in protocols regarding Subject Withdrawal Criteria? A) When and how to withdraw subjects from the trial/IP treatment. B) The type and timing of the data to be collected for withdrawn subjects. C) Whether and how subjects are to be replaced. D) The follow-up for subjects withdrawn from investigational product treatment/trial treatment. E) All of the above

E) All of the above

According to the Monitor's Responsibilities sections of ICH GCP which of the following should be clearly reported on the eCRF. 1) A visit that subject fails to make 2) Tests that are not conducted 3) Examinations that are not performed

1, 2 and 3.

According to the principles of ICH GCP before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for who? A) individual trial subject and society B) Doctors C) Dentists

A) individual trial subject and society

All noxious and unintended responses to a medicinal product related to any dose should be considered as an: A) AE B) ADR (Adverse Drug Reaction) C) UADR

B) ADR (Adverse Drug Reaction)

Any untoward medical occurrence in a patient or clinical Investigaton subject administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with his treatment A) AE B) ADR (Adverse Drug Reaction) C) UADR

A) AE

After the completion or termination of the trial, where should the clinical study report be filed? A) Investigator Files B) Sponsor Fies C) Both Investigator and Sponsor Files

C) Both Investigator and Sponsor Files

After the completion or termination of the trial, where should the completed subject identification code list be filed? A) Investigator Files Only B) Sponsor Files Only C) Both Investigator and Sponsor Files

A) Investigator Files Only

After the completion or termination of the trial, where should the documentation of investigational product destruction be filed? A) In the Investigator file, if destroyed there, in the sponsor files B) Investigator files C) Sponsor Files

A) In the Investigator file, if destroyed there, in the sponsor files

After the completion or termination of the trial, where should the final trial close-out monitoring report be filed? A) In the sponsor files only B) In the investigator files only C) Both files

A) In the sponsor files only

After the completion or termination of the trial, where we should the treatment allocation and decoding documentation be filed? A) In the sponsor files only B) In the investigator files only C) Both files

A) In the sponsor files only

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. A) Applicable Regulatory Requirements B) SOPs C) Written Procedures

A) Applicable Regulatory Requirements

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP) and the applicable regulatory requirements A) Approval (in relation to institutional Review Boards) B) Permission to proceed C) Go ahead to do a trial

A) Approval (in relation to institutional Review Boards)

As per ICH GCP section 4.5 compliance to protocol, who should document and explain any deviation from the approved protocol? A) Investigator B) Sponsor C) CRA D) CRO

A) Investigator

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements(s) A) Audit B) Capacity

A) Audit

Approaches to data analysis that provide a posterior probability Distibution for some parameter (eg. treatment effect) derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. A) Bayesian Approaches B) Common Approaches C) Statistical Approaches

A) Bayesian Approaches

Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the" A) Protocol and investigators brochure B) Protocol C) Investigator Brochure

A) Protocol and investigators brochure

Before initiating a trial, the investigator/institution should have written and dates approval/favorable opinion from the IRB/IEC for the: 1) Protocol 2) Consent form updates 3) Subject recruitment procedures 4) Written informed consent form

All of them

Before the clinical phase of the trial commences where should certificate of analysis of investigational product(s) shipped be filed? A) Sponsor File Only B) Investigaton File Only

A) Sponsor File Only

Before the clinical phase of the trial commences where should master randomization list be filed? A) Sponsor file only B) Sponsor file and third party C) Investigator file

B) Sponsor file and third party

Before the clinical phase of the trial commences where should the decoding procedures for blinded trials be filed? A) The sponsor, a third party if applicable, and the investigator files B) Investigator file only

A) The sponsor, a third party if applicable, and the investigator files

Before the clinical phase of the trial commences where should the insurance statement be filed? A) Sponsor B) Investigator C) Both the sponsor and the investigator files

C) Both the sponsor and the investigator files

Before the clinical phase of the trial commences where should the investigator's brochure be files? A) Sponsor B) Investigator C) Both the investigator and sponsor files

C) Both the investigator and sponsor files

Before the clinical phase of the trial commences, where should the medical, laboratory, technical procedures and test certifications be filed? A) Sponsor B) Investigator C) The investigator files, where required, and the sponsor file

C) The investigator files, where required, and the sponsor file

Before the clinical trial phase of the trial commences where should the pre-trial monitoring report be filed? A) Sponsor Files Only B) Investigator Files Only C) Both Files

A) Sponsor Files Only

Before the clinical phase of the trial commences where should the sample of labels attached to investigational product(s) be filed? A) The sponsor file only B) Investigator file only

A) The sponsor file only

Before the clinical phase of the trial commences where should the shipping records for IP and trial related materials be filed? A) Both the Sponsor and the Investigator files C) Sponsor D) Investigator

A) Both the Sponsor and the Investigator files

Bias (statistical and operational)

the systematic tendency of any factors associated with the design, conduct, analysis, and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. Bias introduced through deviations in conduct is referred to as "operational" bias. The other sources of bias listed above are referred to as a "statistical"

Blind review

The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for purpose of finalizing the planned analysis

Case Report Form (CRF)

A printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

Content Validity

The extent to a which a variable ( e.g rating scale) measures what is supposed to measure.

Contract Research Organization (CRO)

An individual or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-relate duties and functions. This could be data management and/or monitoring.

Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Double Dummy

A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and undistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment: either A (active) and B(placebo) or A(placebo) and B (active)

Dropout

A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol

During the clinical conduct of a trial, where should documentation of CRF corrections be filed? A) A copy with the investigator and the original with the sponsor B) Sponsor only C) Investigator only

A) A copy with the investigator and the original with the sponsor

During the clinical conduct of a trial, where should investigator brochure updates be filed? A) Both the sponsor and investigator files B) Sponsor Only C) Investigator Only

A) Both the sponsor and investigator files

During the clinical conduct of a trial, where should source documents be filed? A) In the investigator file only B) In the sponsor file only

A) In the investigator file only

During the clinical conduct of a trial, where should the investigational products accountability at the site be filed? A) Both the sponsor and investigator files B) Sponsor C) Investigator

A) Both the sponsor and investigator files

During the clinical conduct of a trial, where should the monitoring visit reports be filed? A) Sponsor Files Only B) Investigator Files Only C) Both

A) Sponsor Files Only

During the clinical conduct of a trial, where should the record of retained body fluids/tissue samples (if any) be filed? A) Both the sponsor and the investigator files B) Investigator Only C) Sponsor Only

A) Both the sponsor and the investigator files

During the clinical conduct of a trial, where should the signature sheet be filed? A) Both the sponsor files and investigator files B) sponsor files C) investigator files

A) Both the sponsor files and investigator files

During the clinical conduct of a trial, where should the signed, date and completed case report forms be filed? A) A copy with the investigator, original with the sponsor

During the clinical conduct of a trial, where should the subject enrollment log be filed? A) The investigators files only B) Sponsor files only C) Both

A) The investigators files only

During the clinical conduct of a trial, where should the subject identification code list be files? A) Sponsor files only B) Investigator files only C) Both

B) Investigator files only

During the clinical conduct of a trial, where should the subject screening log be filed? A) The sponsor files where required, and the investigators log B) Sponsor file only C) investigator file only

A) The sponsor files where required, and the investigators log

During the clinical conduct of the trial how completed CRFs be filed? A) Copy in the investigator file and original in sponsor files

During the clinical conduct of the trial where should monitoring reports be filed? A) The sponsor files only B) The investigator files only C) ERB Files only

A) The sponsor files only

During the clinical conduct of the trial where should new batches of certificate of analysis of investigational product(s) be files? A) The sponsor files only B) The investigator files only C) ERB Files only

A) The sponsor files only

Equivalence Trial

A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. this is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences.

During the clinical conduct of the trial where should signed informed consent forms be filed? A) The sponsor files only B) The investigator files only

B) The investigator files only

For multicenter trials, the sponsor should ensure that? 1. All investigators conduct the trial in strict compliance with the protocol agreed by the sponsor and, if required, by the regulatory authorities and given approval-favorable opinion by the IRB/EIC 2. The CRFs are designed to capture the required data at all multicenter trial sites. For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data. 3. The responsibilities of coordinating investigator (s) and the other participating investigators are documented prior to the start of the trial 4. All investigates are given instructions on following protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs. 5. Communication between investigators is facilitated

1, 2, 3, 4 and 5

Frequentist Methods

A. Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation.

Full Analysis Set

The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomized subjects by minimal and justified elimination of subjects.

Generalization - Generalisability

The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.

Global Assessment Variable

A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in a state of a subject

How long should the IRB/IEC take to review a proposed clinical trial and document its views in writing? A) 1 month B) 1 years C) A reasonable time

C) A reasonable time

ICH GCP states the protocol should generally include stopping rules for individual subjects, parts of trials and entire trial. What other term does it specify in addition to Stopping Rules? A) Discontinuation Criteria B) Stopping Criteria C) Stoppage Criteria

A) Discontinuation Criteria

ICH GCP states the scientific integrity of the trial and the credibility of the data from the trial depend substantially on the? A) Trial Design B) Trial Conduct C) Protocol

A) Trial Design

In ICH GCP what is the difference in requirements between a non-therapeutic and a therapeutic clinical trial? A) No difference B) Oral and proxy consent is not normally allowable for non-therapeutic trial C) They don't' require consent

B) Oral and proxy consent is not normally allowable for non-therapeutic trial

in ICH GCP what is the recommended timeline for the monitor to write the monitoring report? A) 1 month 2) 6 months 3) There is no recommendation

3) There is no recommendation

Included Term

The lowest level of dictionary term to which the investigator description is coded

IDMC (Independent Data Monitoring Committee)

Included Termination

The lowest level of dictionary term to which the investigator description is coded.

IDMC (Independent Data Monitoring Committee)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Institution (medical)

Any public or private or agency or medical or dental facility where clinical trials are conducted.

Intention to treat principle

The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed-up, assessed and analyzed as members of that groups irrespective of their compliance to the planned course of treatment. This means that all participants are analyzed in the group to which they were randomized regardless of whether they received all or any of the treatment to which they were assigned.

Inter-rater reliability

The property of yielding equivalent results when used by different raters on different occasions.

Interim Analysis

Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial.

Investigator should fully inform the subject if the subject is unable to provide informed consent, the (????), of all pertinent aspects of the trial including the written information and the approval/favorable opinion by the IRB/IEC. A) CRA B) CRC C) Sponsor D) Legally Responsible Representative

D) Legally Responsible Representative

Meta-Analysis

A formal evaluation of the quantitative evidence from two or more trials bearing on the same question

Multicenter Trial

A clinical trial conducted according to a single protocol but at more than one site and therefore carried out by more than one investigator

Non-Inferiority Trial

A trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo control)

Per Protocol Set

A set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol deviations.

Preferred term

The level of grouping of included terms typically used in reporting frequency of occurrence.

Product Safety

The medical risks to a subject, usually assessed in a clinical trial by laboratory tests, vital signs, clinical adverse events, and other safety tests

Protocol Amendment

A written description of a change(s) to a formal clarification of a protocol

Qualitative Interaction

the direction of the contrast differs for at least one level of the factor

Quantitative Interaction

the magnitude of the contrast differs at the different levels of the factor

Responsibility for investigational product(s) accountability at the trial site(s) rests with ? a) Investigator/institution b) sponsor c) CRO d) monitor

a) Investigator/institution

Sponsor is responsible for ???? of the investigational product? a) Safety Evaluation b) Nothing

a) Safety Evaluation

Statistical Analysis Plan

Document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.

Subinvestigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows)

Superiority Trial

A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control)

Surrogate Variable

A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical

Who is responsible for the ongoing safety evaluation of the investigational product? A) Sponsor B) Investigator C) CRA D) CRO E) Monitor

A) Sponsor

The determination of the extent and nature of monitoring should be based on considerations such as ? A) The objective, purpose, design, complexity, blinding, size, and endpoints of the trial B) Sponsor Decision D) Investigator Decision

A) The objective, purpose, design, complexity, blinding, size, and endpoints of the trial

The financial aspects of the trial should be documented in an agreement between: A) sponsor and investigator/institution B) None

A) sponsor and investigator/institution

The ICH GCP Guideline Integrated Addendum provides a unified standard for the ???? to facilitate the mutual acceptance of data from the clinical trials by the regulatory authorities. A) US B) The EU, Japan, US, Australia, Canada, Nordic Countries, and the World Health Organization

B) The EU, Japan, US, Australia, Canada, Nordic Countries, and the World Health Organization

The ICH GCP guideline should be read in conjunction with other ICH guidelines relevant to ???? of clinical trials? A) Conduct B) Design C) Complexity

A) Conduct

The investigator should ensure ???? of the data reported to the sponsor in the CRFs and in all required reports? A) Accuracy, completeness, Legibility, and timelines B) quality c) something else

A) Accuracy, completeness, Legibility, and timelines

The investigator should be qualified by ???? to assume responsibility for the proper conduct of the trial? A) Education B) Training C) GCP D) Experience E) A, B, D

E) A, B, D

The IRB/IEC should ensure that information regarding payment to subjects, including the ???? to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified. A) Bank Account B) Method, Amount, Schedule of Payments C) Interest Info

B) Method, Amount, Schedule of Payments

The IRB/IEC should establish, document in writing, and follow its procedures, which should include: 1) Determining its composition (names and qualifications of the members) and the authority under which it is established. 2) Scheduling, notifying its members of, and conducting its meetings. 3) Conducting initial and continuing review of trials. 4) Determining the frequency of continuing review as appropriate. 5) Providing according to the applicable regulatory requirements, expedited review and approval/favorable opinion of minor change (s) in ongoing trials that have the approval/favorable opinion of the IRB/IEC. 6) Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favorable opnion of the trial. 7) 1,2,3,4,5,6

7) 1,2,3,4,5,6

The monitoring plan should describe the monitoring strategy, the responsibilities and the monitoring methods to be used and?? A) the rationale for their use B) update schedule C) printing schedule

A) the rationale for their use

The review and follow up of the monitoring report with the sponsor should be documented by ? A) The sponsor's designated representative D) CRO

A) The sponsor's designated representative

Tolerability

Represents the degree to which overt adverse effects can be tolerated by the subject

Treatment Effectiveness

An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments.

Treatment Emergent

An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pretreatment state

Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g investigator's brochure for an unapproved investigational medicinal product)

What are the elements of the risk-based approach of quality management systems? A) Critical Process B) Data Identification C) Risk Identification D) Risk Evaluation E) Risk Control F) Risk Communication G) Risk Review H) Risk Reporting I) All of the above

I) All of the above

What does ICH GCP say the investigator should do in the event of premature unblinding? A) Promptly document and explain to the sponsor? B) Document and report to Monitor C) Nothing

A) Promptly document and explain to the sponsor?

What does ICH GCP section 5.18.3 Extent and Nature of monitoring state about the method of statistically controlled sampling? A) May be an acceptable method for selecting the data to be verified. B) Cannot be used to review data.

A) May be an acceptable method for selecting the data to be verified.

What does ICH GCP state that the members of an IRB/EIC should collectively have the qualifications and experience to review and evaluate of the proposed trial? A) Medical Aspects, Science, Ethics B) Statistical Aspects C) GCP knowledge

A) Medical Aspects, Science, Ethics

What is needed to complete the following statement in ICH GCP Section 4.9: Data reported on the eCRF that are derived from source documents should be consistent with the source documents or: A) the discrepancies should be explained B) the discrepancies should be ignored

A) the discrepancies should be explained

What is the IRB/IEC composition recommendation in ICH GCP? A) At least five members B) at least one member whose primary area of interest is in a nonscientific area C) at least one member who is independent of the institution/trial site D) A, B, C

D) A, B, C

What is true for subjects in emergency situations when prior consent is not possible? A) They need prior consent B) they can be included if the measures described in the protocol and/or elsewhere with documented approval/favorable opinion by the IRB/IEC.

B) they can be included if the measures described in the protocol and/or elsewhere with documented approval/favorable opinion by the IRB/IEC.

What words are missing from the following in ICH GCP: The sponsor should update the ? ? ? as significant new information becomes available? A) Monitoring plan B) Investigators brochure C) Protocol

B) Investigators brochure

What words are missing from the following statement in ICH GCP: For ________ the investigator should supply the sponsor and the IRB/IEC with any additional requested information?? A) Reported Deaths B) Reported Enrollments C) Reported Discontinuations

A) Reported Deaths

Where should final trial close-out monitoring report be filed? A) Sponsor File Only B) Investigator File Only

A) Sponsor File Only

Where should subject identification code list be filed? A) Sponsor File Only B) Investigator File Only

B) Investigator File Only

Where should the audit certificate be filed? A) Sponsor File Only B) Investigator File Only

A) Sponsor File Only

Where should trial initiation report be filed? A) Sponsor File Only B) Investigator File Only C) Both the Sponsor and investigator files

C) Both the Sponsor and investigator files

Which of the following documents should be obtained by IRB/IEC as per ICH GCP? A) Subject recruitment site B) Subject recruitment procedures C) subject recruitment updates D) Subject recruitment strategy

B) Subject recruitment procedures

Which of the following is NOT in the list given by ICH GCP for the factors guiding the audit plan and procedures for a trial audit? A) importance of the trial to submissions to regulatory authorities B) the number of subjects in the trial, C) the type and complexity of the trial D) the level of risks to the trial subjects E) the duration of treatment for each trial subject?

E) the duration of treatment for each trial subject?

Which of the following is NOT included in protocol section 6.5 selection and withdrawal of subjects: A) Subject inclusion criteria B) Subject exclusion criteria C) Subject withdrawal criteria D) Subject retention criteria

D) Subject retention criteria

Which of the following is the ICH GCP glossary definition of a monitoring report?

A written report from the monitor to the sponsor after each site visit and/or other trial related communication according to the sponsor's SOPs.

Who is responsible for all trial related medical or dental decisions ?

A qualified physician or dentist

Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs.? A) Sponsor B) Investigator

A) Sponsor

Who should ensure that it is specified in the protocol or other written agreement that the investigator/institution will permit trial related monitoring, audits, IRB/IEC review, and regulatory inspections, providing direct access to source data/documents A) Sponsor B) Investigator

A) Sponsor