CRA || QUESTIONS WITH COMPLETE SOLUTIONS!!
PQV correct answers Pre-Qualification Visit is conducted in order to confirm whether a site
is qualified to participate in the study. There is ONLY 1 visit per site per study. AKA: Pre-
Site Selection Visit, Qualification Site Visit
SIV correct answers Site Initiation Visit is conducted once the site has been selected &
receives Green Light Approval (Green Light Approval occurs after all essential documents
are collected & IRB approves the site). ONLY 1 visit per site per study
RMV correct answers Routine Monitoring Visit is conducted in order to ensure the site is
following study guidelines. During the visit, data is reviewed, the regulatory binder is
maintained, & drug accountability is performed. AKA: Interim Monitoring Visit, Monitoring
Visit
COV correct answers Close Out Visit is conducted at the end of the study or after enrollment
if the site has not enrolled a subject. ONLY 1 per site. During the visit the CRA ensures data
is clean, reconciles TMF, performs drug accountability, ensures lab samples are sent to
central lab & unused drugs are returned, retrieves updated financial disclosure forms,
inactivates system access, obtains retention storage location, collects wet copies, ensures
database is locked, meet with IP to discuss audit potential & retention policy, SSDL is signed
by PI & stop date is entered on log. Also Known As: Termination Visit
IRB correct answers Institutional Review Board is a type of committee used in research that
has been formally designated to approve, monitor, & review biomedical & behavioral
research involving humans. Often conduct some form of risk-benefit analysis in attempt go
determine whether or not research should be completed. Purpose is to assure that appropriate
steps are taken to protect the rights & welfare of humans participating as subjects in a
research study. Also Known As: Independent Ethics Committee, Ethical Review Board,
Research Ethics Board.
CDA correct answers Confidential Disclosure Agreement is a legal contract between the
CRO/Sponsor & the site that outlines the confidential material, knowledge, or information
that the parties wish to share with one another for certain purposes but wish to restrict access
to or by third parties. MUST be rec'd before PQV.
ICH correct answers International Council for Harmonisation is a project that brings together
the regulatory authorities of Europe, Japan, & U.S & experts from the pharmaceutical
industry in the 3 regions to discuss scientific & technical aspects of pharmaceutical product
registration.
PI correct answers Principal Investigator is the primary physician responsible for the conduct
of the study at the site.
Study Coordinator correct answers The person that will be the CRA's primary contact at the
site. They will be delegated to many tasks such as: entering data, reporting SAEs, ordering
study drug, scheduling subject visits, scheduling monitoring visits, & updating site's
regulatory binder.
, Regulatory Coordinator correct answers Person at the site responsible for maintaining the
regulatory binder. They ensure that all essential documents are kept up to date... CVs updated
every 2 years, collecting updated ML, CLIAs, submissions to IRB for approvals, continuing
review (annual re-approvals), study closures, & deviations.
Data Coordinator correct answers Person on site that enters the subject's data & answers EDC
queries.
Clinical Study Roles correct answers ·Data Management
·Clinical Trial Specialist
·CRA
.Clinical Trial Manager
.Project Specialist
·Project Manager
.Project Director
Financial Disclosure Form correct answers Confirms that the PI or Sub-I do not have any
financial interest within the study. It is collected at the beginning & end of the study.
Curricula Vitae (CV) correct answers Resume
Clinical Trial Agreement/Contract correct answers Contract between the CRO & site that
states the agreement of what is expected within the study.
1572 correct answers Statement of Agreement confirms that the PI is responsible for the
overall conduct of the study at the site. It lists the PI's address, address(es) where subjects
will be seen, all lab names & addresses used for the study, the IRB, the Sub-Is, title of the
protocol, & signature & date of the PI
GCP Certificates correct answers Confirms that the site staff has been trained
Investigational Brochure correct answers Comprehensive document summarizing the body of
information about an investigational product. It lists information regarding the safety of the
drug & statistical data around the adverse events associated with the drug.
CLIA correct answers Clinical Laboratory Improvement Amendments is the lab certificate
that certifies the lab. It expires yearly & updated copy needs to be collected
CAP correct answers Certified Authorization Professional is a certification of objective
measure of the knowledge, skills, & abilities required for personnel involved in the process of
authorizing & maintaining information systems
Reference Ranges correct answers Range of numbers in which a value is placed to determine
if a result is normal
Laboratory Documents correct answers ·CAP
·CLIA
·RR
·lab director's CV
PQV correct answers Pre-Qualification Visit is conducted in order to confirm whether a site
is qualified to participate in the study. There is ONLY 1 visit per site per study. AKA: Pre-
Site Selection Visit, Qualification Site Visit
SIV correct answers Site Initiation Visit is conducted once the site has been selected &
receives Green Light Approval (Green Light Approval occurs after all essential documents
are collected & IRB approves the site). ONLY 1 visit per site per study
RMV correct answers Routine Monitoring Visit is conducted in order to ensure the site is
following study guidelines. During the visit, data is reviewed, the regulatory binder is
maintained, & drug accountability is performed. AKA: Interim Monitoring Visit, Monitoring
Visit
COV correct answers Close Out Visit is conducted at the end of the study or after enrollment
if the site has not enrolled a subject. ONLY 1 per site. During the visit the CRA ensures data
is clean, reconciles TMF, performs drug accountability, ensures lab samples are sent to
central lab & unused drugs are returned, retrieves updated financial disclosure forms,
inactivates system access, obtains retention storage location, collects wet copies, ensures
database is locked, meet with IP to discuss audit potential & retention policy, SSDL is signed
by PI & stop date is entered on log. Also Known As: Termination Visit
IRB correct answers Institutional Review Board is a type of committee used in research that
has been formally designated to approve, monitor, & review biomedical & behavioral
research involving humans. Often conduct some form of risk-benefit analysis in attempt go
determine whether or not research should be completed. Purpose is to assure that appropriate
steps are taken to protect the rights & welfare of humans participating as subjects in a
research study. Also Known As: Independent Ethics Committee, Ethical Review Board,
Research Ethics Board.
CDA correct answers Confidential Disclosure Agreement is a legal contract between the
CRO/Sponsor & the site that outlines the confidential material, knowledge, or information
that the parties wish to share with one another for certain purposes but wish to restrict access
to or by third parties. MUST be rec'd before PQV.
ICH correct answers International Council for Harmonisation is a project that brings together
the regulatory authorities of Europe, Japan, & U.S & experts from the pharmaceutical
industry in the 3 regions to discuss scientific & technical aspects of pharmaceutical product
registration.
PI correct answers Principal Investigator is the primary physician responsible for the conduct
of the study at the site.
Study Coordinator correct answers The person that will be the CRA's primary contact at the
site. They will be delegated to many tasks such as: entering data, reporting SAEs, ordering
study drug, scheduling subject visits, scheduling monitoring visits, & updating site's
regulatory binder.
, Regulatory Coordinator correct answers Person at the site responsible for maintaining the
regulatory binder. They ensure that all essential documents are kept up to date... CVs updated
every 2 years, collecting updated ML, CLIAs, submissions to IRB for approvals, continuing
review (annual re-approvals), study closures, & deviations.
Data Coordinator correct answers Person on site that enters the subject's data & answers EDC
queries.
Clinical Study Roles correct answers ·Data Management
·Clinical Trial Specialist
·CRA
.Clinical Trial Manager
.Project Specialist
·Project Manager
.Project Director
Financial Disclosure Form correct answers Confirms that the PI or Sub-I do not have any
financial interest within the study. It is collected at the beginning & end of the study.
Curricula Vitae (CV) correct answers Resume
Clinical Trial Agreement/Contract correct answers Contract between the CRO & site that
states the agreement of what is expected within the study.
1572 correct answers Statement of Agreement confirms that the PI is responsible for the
overall conduct of the study at the site. It lists the PI's address, address(es) where subjects
will be seen, all lab names & addresses used for the study, the IRB, the Sub-Is, title of the
protocol, & signature & date of the PI
GCP Certificates correct answers Confirms that the site staff has been trained
Investigational Brochure correct answers Comprehensive document summarizing the body of
information about an investigational product. It lists information regarding the safety of the
drug & statistical data around the adverse events associated with the drug.
CLIA correct answers Clinical Laboratory Improvement Amendments is the lab certificate
that certifies the lab. It expires yearly & updated copy needs to be collected
CAP correct answers Certified Authorization Professional is a certification of objective
measure of the knowledge, skills, & abilities required for personnel involved in the process of
authorizing & maintaining information systems
Reference Ranges correct answers Range of numbers in which a value is placed to determine
if a result is normal
Laboratory Documents correct answers ·CAP
·CLIA
·RR
·lab director's CV
