Committees
This Committee comprises of department and team leads who determine the operational aspects of a new study.
What is FROC (Feasibility Review and Operations Committee)
This document reports an Investigator's Conflict of Interest with a particular sponsor.
What is an FDF (Financial Disclosure Form)?
This policy outlines the assignment of study responsibilities on a clinical trial.
What is Policy 28 - Delegation of Authority Log?
This initial research, ethics, compliance and safety training is completed by all research staff to be approved at the IRB.
What is CITI Training?
Pembrolizumab was FDA approved in 2014 for the treatment of Melanoma and marketed under this name.
What is KeyTruda?
Spring begins in this month in the Southern Hemisphere of the Earth.
What is September?
This Committee reviews the scientific validity of all protocols involving human subjects as a mandate of the NCI.
What is the PRMC (Protocol Review and Monitoring Committee)?
This document is an agreement with the investigator that he/she will comply with FDA regulations related to conduct of the investigational drug or biologic.
What is the FDA 1572 Form?
The Protocol Training Policy outlines the process for sending out training to staff in the case of a protocol amendment. What document is to be routed to all staff for training?
What is the Protocol Summary of Changes?
This regulation is divided into 50 titles that represent broad areas, clinical trials largely comprise section 21.
What are the Code of Federal Regulations?
Atezolizumab is FDA approved in Melanoma, non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma and is marketed under this name.
What is Tecentriq?
In Greek mythology, this is the goddess of spring and nature.
This Committee conducts routine audits to ensure data integrity and compliance on KCI's Investigator Initiated Protocols.
What is the QAC (Quality Assurance Committee)?
This document is a legally binding agreement that manages the relationship between the sponsor that may be providing the investigation drug or device.
What is a Clinical Trial Agreement (CTA)?
What is two weeks?
This document was created as a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA).
What is the Declaration of Helsinki?
Tisagenlecleucel is approved to treat B-cell non-Hodgkin lymphoma and is marketed as this name.
What is Kymriah?
This Hindu festival is celebrated as the festival of colors, love and spring.
What is Holi?
This Committee routinely monitors the data quality, patient safety and safety reporting on KCI's Investigator Initiated Protocols.
What is the DSMC (Data Safety Monitoring Committee)?
This FDA submission form is used for individual patient access INDs outside of a clinical trial.
What is the FDA Form 3926?
Our FDA 1572 Policy outlines the need to add an outside local lab if used how many times by a patient on trial?
What is more than once?
This document was published in 1974, which identifies the basic ethic principles and guidelines that address ethical issues arising from the conduct of research with human subjects
What is the Belmont report?
What is Yervoy?
This country originated the tradition of the Easter Bunny.
What is Germany?
This previous WSU IRB Committee board was dismantled in 2021 and had board meetings every other Wednesday allowing a faster turn around for the fast paced studies they reviewed.
What is the Phase 1 (PH1) IRB Committee?
This document is often updated on a yearly basis to include a comprehensive compilation of clinical and nonclinical data in relation to the drug.
What is an Investigator's Brochure?
This procedure manual outlining all KCI site capabilities and processes is given to all sponsors at the time of initial outreach of participation.
What is the KCI Site Feasibility Document?
This rule of ethics calls for respect for persons, beneficence and justice as well as the need for human subject protections by obtaining consent and review by an IRB.
What is The Common Rule?
Talazoparib is FDA approved in the treatment of Breast and Prostate cancer and is marketed under this name.
What is Talzenna?
This is the most common spring allergy trigger.
What is pollen?