Qualifications for Clinical Research
This document verifies a potential investigator has the necessary training and experience to conduct a clinical trial
What is a CV
Also known as an SIV predecessor this visit is conducted to access site and readiness before trial initiation
What is a PSV Pre-Study Visit
What two ways can a pre study qualification visit be held?
What is remote and/or on site
What is Form FDA 1572
What is the Unites States of America
What is a GCP Certificate
The sponsor of CRO representative conducting the PSV typically holds this role
What is a CRA
This is the name of the binder or systems that houses all essential documents for the trial?
What is the ISF (Investigator site file) or Regulatory Binder
Before a site can begin screening, this document must be signed by the IRB and confirms approval of the trial protocol and ICF
What is the IRB Approval letter
Cinco de Mayo Commemorates the Mexican victory over this country's army at the Battle of Puebla?
What is France
Sponsor often request this before selecting a research site confirming the staffs and facility resources
This document is reviewed during the PSV, details the study protocol and procedures
What is the Investigator Brochure or Study Protocol
A Site Initiation visit may occur after site has received the following 3 items
What is 1) IRB Approval 2) executed contract 3) finalized budget
This document must be signed by all study personnel before they can engage in any study-related procedures.
What is the Delegation of Authority Log (DOA Log)?
The Battle of Puebla took place during this year?
What is 1862
This type of license must be valid and unrestricted for a physician to serve as principle investigator
What is a medical license
This Critical component of the PSV ensures the site has the necessary resources, such as staff and equipment?
What is the site feasibility assessment
Who is responsible for scheduling and arranging the initiation visit on behalf of the PI as requested by a sponsor representative?
During the Site Initiation Visit (SIV), this critical regulatory binder section is reviewed to ensure all required approvals and training are documented.
What is the Regulatory Binder?
This Mexican general led the army that defeated the French forces at Puebla?
Who is General Ignacio Zaragonza?
Sub Investigator and Coordinators often need this proof of research specific skills and responsibility
What is a Delegation of Authority log or Training documentation
During the PSV this document outlines the responsibilities of the sponsor and site
What is the Clinical Trial Agreement (CTA)
What are some research involving specific departments that may involve a meeting or/ tour during site initiation visits
What is the Pharmacy, OR and Lab
The PI is ultimately responsible for the study, but this team member typically conducts the SIV presentation and walks through protocol procedures.
Who is the Clinical Research Coordinator (CRC)?
Contrary to popular belief, Cinco de Mayo is NOT this type of national holiday in Mexico?
What is Independance Day