CRA EXAM WITH ALL CORRECT & 100% VERIFIED
ANSWERS|ACTUAL COMPLETE EXAM|ALREADY
GRADED A+
PQV ✔Correct Answer-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 Answer-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 Answer-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 Answer-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 Answer-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 Answer-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 Answer-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 Answer-Principal Investigator is the primary physician responsible for the conduct of
the study at the site.
Study Coordinator ✔Correct Answer-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 Answer-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 Answer-Person on site that enters the subject's data & answers EDC
queries.
Clinical Study Roles ✔Correct Answer-·Data Management
·Clinical Trial Specialist
·CRA
.Clinical Trial Manager
.Project Specialist
·Project Manager
.Project Director
Financial Disclosure Form ✔Correct Answer-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 Answer-Resume
Clinical Trial Agreement/Contract ✔Correct Answer-Contract between the CRO & site that states
the agreement of what is expected within the study.
1572 ✔Correct Answer-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 Answer-Confirms that the site staff has been trained
Investigational Brochure ✔Correct Answer-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 Answer-Clinical Laboratory Improvement Amendments is the lab certificate that
certifies the lab. It expires yearly & updated copy needs to be collected
CAP ✔Correct Answer-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 Answer-Range of numbers in which a value is placed to determine if a
result is normal
Laboratory Documents ✔Correct Answer-·CAP
·CLIA
·RR
·lab director's CV
Study start-up documents ✔Correct Answer-·FDF
ANSWERS|ACTUAL COMPLETE EXAM|ALREADY
GRADED A+
PQV ✔Correct Answer-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 Answer-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 Answer-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 Answer-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 Answer-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 Answer-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 Answer-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 Answer-Principal Investigator is the primary physician responsible for the conduct of
the study at the site.
Study Coordinator ✔Correct Answer-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 Answer-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 Answer-Person on site that enters the subject's data & answers EDC
queries.
Clinical Study Roles ✔Correct Answer-·Data Management
·Clinical Trial Specialist
·CRA
.Clinical Trial Manager
.Project Specialist
·Project Manager
.Project Director
Financial Disclosure Form ✔Correct Answer-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 Answer-Resume
Clinical Trial Agreement/Contract ✔Correct Answer-Contract between the CRO & site that states
the agreement of what is expected within the study.
1572 ✔Correct Answer-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 Answer-Confirms that the site staff has been trained
Investigational Brochure ✔Correct Answer-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 Answer-Clinical Laboratory Improvement Amendments is the lab certificate that
certifies the lab. It expires yearly & updated copy needs to be collected
CAP ✔Correct Answer-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 Answer-Range of numbers in which a value is placed to determine if a
result is normal
Laboratory Documents ✔Correct Answer-·CAP
·CLIA
·RR
·lab director's CV
Study start-up documents ✔Correct Answer-·FDF
