CRA || QUESTIONS WITH COMPLETE SOLUTIONS!!
A Site Feasibility questionnaire typically informs the sponsor on:*** correct answers b.
Team composition and size
d. Experience of site staff
e. Risks when selecting this site
f. Available resources on site
g. Qualifications of site staff
h. Limiting Factors on site
Non-clinical animal studies are regulated by: correct answers GLP
The purpose of the Site Selection Visit (SSV) is: correct answers a. to verify that investigator
is qualified and has adequate resources to perform the trial
b. for the investigator to decide on participation in the trial
d. to determine the roles and responsibilities of the research team
f. for the sponsor to include this investigator
CRF stands for correct answers case report form
Arrange the steps of the data life-cycle in the correct sequence correct answers collection &
creation
classification & processing
manipulation
analysis
preserve & store
release & access
retention & reuse
archival
The Declaration of Helsinki includes the following points: correct answers c. Medical
research must be based on a thorough knowledge of the scientific literature. That is correct.
e. Medical research in human subjects must conform to generally accepted scientific principle
Please select what defines a closed site: correct answers a. all required documents have been
collected
c. a site closure visit has been performed
d. all required trial supplies have been collected
When was the Food Drug and Cosmetic Act introduced in the US? correct answers 1938
Risk-Based Monitoring may be executed in all following scenarios:
on-site,
on-site and centralized, or
centralized only. correct answers true
Tasks of the Monitor during Site Selection Visit typically include: correct answers a.
discusses approval process by the IEC and it's duration
b. site has access to subjects as agreed
c. evaluates experience of investigator and his team against criteria in the study protocol
, d. verify site meets protocol requirements
e. evaluates the facilities of the site
Identify the correct types of Serious Adverse Event (SAE)** correct answers a. life-
threatening
b. persistent or significant disability/incapacity
e. IP
Data about data are called metadata. correct answers true
If a subject is withdrawn from a clinical study, none of their data is analysed. correct answers
false
Where was the European Medicines Agency previously located? correct answers london
What do you do as preparation for an inspection? correct answers a. Notify management and
all relevant staff
c. Reserve a room for inspectors to work and review documents, either on paper or on
workstations
f. Provide inspectors access to your document management system so they can easily find
documents they want to check
Site closures may occur before data lock. correct answers true
Who is today a member of ICH? correct answers b.Swissmedic
c. Anvisa, Brazil
e. Health Canada
The Investigator can delegate IMP responsibility. correct answers true
Which of the following is/are true? correct answers a. Essential Documents are the primary
source of information that inspectors / auditors are looking at.
b. Essential Documents are divided into documents produced before, during and after trial.
d. Essential Documents individually and collectively permit evaluation of the conduct of a
study and the quality of data produced.
Phase 2 studies are usually dose-finding studies in preparation for Phase 3. correct answers
true
An Investigational Medicinal Product is a medicine being studied in a clinical trial. correct
answers true
What are the key elements in the Investment Decision Elements in the process of drug
development? correct answers a. resources
d. budget
e. defined group of activities
Feedback
Where is the Food and Drug Administration located? correct answers washington
A Site Feasibility questionnaire typically informs the sponsor on:*** correct answers b.
Team composition and size
d. Experience of site staff
e. Risks when selecting this site
f. Available resources on site
g. Qualifications of site staff
h. Limiting Factors on site
Non-clinical animal studies are regulated by: correct answers GLP
The purpose of the Site Selection Visit (SSV) is: correct answers a. to verify that investigator
is qualified and has adequate resources to perform the trial
b. for the investigator to decide on participation in the trial
d. to determine the roles and responsibilities of the research team
f. for the sponsor to include this investigator
CRF stands for correct answers case report form
Arrange the steps of the data life-cycle in the correct sequence correct answers collection &
creation
classification & processing
manipulation
analysis
preserve & store
release & access
retention & reuse
archival
The Declaration of Helsinki includes the following points: correct answers c. Medical
research must be based on a thorough knowledge of the scientific literature. That is correct.
e. Medical research in human subjects must conform to generally accepted scientific principle
Please select what defines a closed site: correct answers a. all required documents have been
collected
c. a site closure visit has been performed
d. all required trial supplies have been collected
When was the Food Drug and Cosmetic Act introduced in the US? correct answers 1938
Risk-Based Monitoring may be executed in all following scenarios:
on-site,
on-site and centralized, or
centralized only. correct answers true
Tasks of the Monitor during Site Selection Visit typically include: correct answers a.
discusses approval process by the IEC and it's duration
b. site has access to subjects as agreed
c. evaluates experience of investigator and his team against criteria in the study protocol
, d. verify site meets protocol requirements
e. evaluates the facilities of the site
Identify the correct types of Serious Adverse Event (SAE)** correct answers a. life-
threatening
b. persistent or significant disability/incapacity
e. IP
Data about data are called metadata. correct answers true
If a subject is withdrawn from a clinical study, none of their data is analysed. correct answers
false
Where was the European Medicines Agency previously located? correct answers london
What do you do as preparation for an inspection? correct answers a. Notify management and
all relevant staff
c. Reserve a room for inspectors to work and review documents, either on paper or on
workstations
f. Provide inspectors access to your document management system so they can easily find
documents they want to check
Site closures may occur before data lock. correct answers true
Who is today a member of ICH? correct answers b.Swissmedic
c. Anvisa, Brazil
e. Health Canada
The Investigator can delegate IMP responsibility. correct answers true
Which of the following is/are true? correct answers a. Essential Documents are the primary
source of information that inspectors / auditors are looking at.
b. Essential Documents are divided into documents produced before, during and after trial.
d. Essential Documents individually and collectively permit evaluation of the conduct of a
study and the quality of data produced.
Phase 2 studies are usually dose-finding studies in preparation for Phase 3. correct answers
true
An Investigational Medicinal Product is a medicine being studied in a clinical trial. correct
answers true
What are the key elements in the Investment Decision Elements in the process of drug
development? correct answers a. resources
d. budget
e. defined group of activities
Feedback
Where is the Food and Drug Administration located? correct answers washington
