STUDY ROLES
Medical Physician responsible for overseeing all aspects of the clinical trial. Delegates staff to perform certain duties and responsibilities.
What is the Principal Investigator?
FDA agreement with the Principal investigator which provides the qualifications and information to the sponsor which assures that the PI will comply with FDA regulations.
What is the 1572?
Reporting of events that have a reasonable possibility of causing harm to a participant while undergoing treatment in a clinical trial
What is a safety report?
Evaluating the potential and capacity to see if a clinical trial is worth pursuing and conducting. Deals with timelines, target goals and financial costs associated with the trial.
What is clinical trial feasibility?
This regulatory coordinator has eyelashes that look fake but are REAL, had red hair as a child, and has an extra bone in each foot.
Who is Kristen?
Delegated by the PI, this role manages and oversees the daily patient records, activities, protocols, and care during the clinical trial.
What is a Clinical Research Coordinator?
Filled out by the delegated team member to verify that there is no financial obligation or ties to the sponsor or company funding the clinical trial
What is the Financial disclosure form?
Trials operating manual which ensures that all researchers perform a trial in the same way on similar subjects and that the data is comparable across all areas. It describes the treatment course of action for patients.
What is the protocol?
The meeting that occurs before the site has been selected for participating in a clinical trial. The sponsor asks questions to determine if the site will be a good fit for the study.
What is an SQV?
This regulatory coordinator loves to eat Ramen, has lived in 5 different states, and has never had a cavity in her life!
Who is Ayla?
Delegated by the PI to assist with data, ordering and maintaining lab kits, and transporting patient samples securely.
What is the Data Management Team?
A brief summary of the experience, qualifications and education of a staff member delegated to the clinical trial study team
What is the CV?
A compiled list and summary of all of the details of a study. It describes the Pharmaceutical product used, the manufacturer, dose form and packaging, safety pharmacology and functions of investigational product to be used in the study.
What is the Investigator Brochure?
During this meeting, the site has been selected and the sponsor and the site discuss the protocols, procedures and enrollment of subjects into the clinical trial.
What is an SIV?
This regulatory coordinator wants to travel to all 50 states before she dies (has already seen 26), was voted most athletic in high school, and her comfort show to binge watch is Gilmore Girls.
Who is Haley?
Prepares, negotiates, and reviews the study budget for clinical trials.
What is the Finance Management Team?
A written agreement willingly signed by the study patient which explains the details, risks and benefits of being a part of a study. The patient signs this in order to give consent to be treated and undergo a clinical trial.
What is the informed consent form?
This is filed if there is an unexpected change or departure from the approved protocol or procedure used in treatment, scheduling, dosing, or Investigator approach made with or without prior IRB approval.
What is a protocol deviation?
Regulatory gives this once the sponsor, finance team and PI have agreed that the study is qualified to begin enrolling subjects and everything is prepared and ready to proceed with the study.
What is the green light?
This regulatory coordinator recently went to the Grand Canyon, the beach is her happy place, and she has 6 children!
This regulatory coordinator is afraid of snakes, has four children, and used to teach first graders.
Who is Kim?
Who is Jenni?
Manages the start up of a clinical trial, SQV, SIV, Post SIV, on boarding staff, DOA's, safety reports, protocol amendments, Investigator brochures, document filing, Continuing reviews, study maintenance, and various duties required by the IRB and PI for a study.
What is the Regulatory Team?
This is where all study related documents are stored, such as the Protocols, Investigator brochures, 1572, FDFs and DOA logs
Where is E-File Cabinet and XCancer Suite
Review of the SIV, protocol, Investigator brochure and any lab manuals that are required for the delegated role. All staff must complete this before being added to a study.
The completion of a study when no more patients are allowed to enroll, follow up is completed and the study is no longer active
What is Close out visit?
This regulatory coordinator really missed football during Covid, absolutely loves dogs, and completes annual Omaha Public Library reading challenges.
Who is Sherry?