Research Study Start-Up Flashcards
What is Research Study Start-Up?
Research study start-up refers to the initial phase of a clinical trial where essential activities are undertaken to initiate and prepare the study for participant enrollment.
List key components of the Research Study Start-Up Phase.
Components include protocol development, regulatory submissions, site selection, investigator training, and setting up necessary infrastructure.
Explain the importance of Protocol Development in Study Start-Up.
Protocol development involves creating a detailed plan for the study, outlining objectives, methods, and procedures. It serves as the blueprint for the entire research.
Identify common Regulatory Submissions during Study Start-Up.
Examples include the Investigational New Drug (IND) application, Institutional Review Board (IRB) submissions, and Ethics Committee applications.
Define Site Selection in the Study Start-Up Phase.
Site selection involves identifying and evaluating potential clinical trial sites based on their capacity, experience, and ability to meet study requirements.
Why is Investigator Training crucial during Study Start-Up?
Investigator training ensures that all site staff are knowledgeable about the study protocol, GCP guidelines, and other regulatory requirements.
What is the purpose of Infrastructure Setup in Study Start-Up?
Infrastructure setup involves establishing systems and processes needed to conduct the trial, including data management, monitoring, and safety reporting.
Explain the role of the Contract and Budget Negotiation in Study Start-Up.
Contract and budget negotiation involves finalizing agreements between sponsors and sites regarding financial matters and study-related responsibilities.
List key documents in the Essential Document Collection during Study Start-Up.
Examples include the protocol, investigator brochure, informed consent forms, regulatory approvals, and financial disclosure forms.
Describe the role of the Principal Investigator (PI) in Study Start-Up.
The PI is responsible for overseeing the study at the site, ensuring compliance with the protocol, and maintaining communication with the sponsor and regulatory authorities
What is a Feasibility Assessment in the context of Site Selection?
Feasibility assessment involves evaluating potential sites to determine if they have the resources, patient population, and capabilities to conduct the clinical trial.
Define Regulatory Binder in the Study Start-Up Phase.
A regulatory binder is a comprehensive collection of documents, including approvals, licenses, and other essential paperwork required for regulatory compliance.
Define Site Activation in the context of Study Start-Up.
Site activation involves the final steps to make a site fully operational for the trial, including regulatory approvals, staff training, and infrastructure setup.
What is the purpose of the Site Initiation Visit (SIV) in Study Start-Up?
The SIV is a visit by the sponsor or monitor to the site to ensure that all necessary preparations for the study have been completed and to initiate the site.
What steps are involved in Protocol Development during Study Start-Up?
Steps include defining research objectives, designing study procedures, specifying inclusion and exclusion criteria, and detailing data collection methods.
