FDA/IRB
This board reviews and approves research involving human subjects.
What is the Institutional Review Board (IRB).
This cancer center provides care to patients from all 99 counties in Iowa and the surrounding area.
What is the Holden Comprehensive Cancer Center.
This document provides participants with key information about a study.
What is a consent form.
This list, frequently included in NCI trials, includes reported and/or potential adverse events associate with an agent using a uniform presentation of events by body system .
What is CAEPRs or Comprehensive Adverse Events and Potential Risks Lists .
What does PSV stand for.
What is 'Pre-site Visit'
An unapproved drug used in a clinical study is called this.
What is an investigational drug.
Before replying to an email that frustrates you, it's often best to do this first.
What is take a moment before responding?
This must be disclosed if it could affect a participant’s decision to enroll.
What are risks.
This form is sent home with your patient on oral investigational drug therapy, and if not available in the “study packet,” should be requested.
What is an oral drug diary?
A patient is paid a $100 flat rate per study Visit.
What is a stipend.
Approval required before beginning many FDA-regulated clinical trials.
What is an IND (Investigational New Drug application).
Speaking and emailing respectfully, listening actively, and choosing appropriate words and tone when interacting with coworkers, patients, or sponsors.
What is professional communication?
Information that can identify an individual.
What is identifiable data.
This AI technology is known to have increased the ability of the coordination team to pre-screen each clinic for potential patients.
What is Triomics?
This department negotiates the CDA.
Who is the Division of Sponsor Programs and the Sponsor.
Adverse events that are unexpected, related, and serious must be reported as this.
What is an unanticipated problem.
This Iowa-based coalition of health professionals, caregivers, researchers, and community members has worked with Holden for years to reduce the statewide burden of cancer.
What is the Iowa Cancer Consortium.
This group requires additional regulatory protections.
Who are vulnerable populations.
This systematic inflammatory response, often seen as a low fever, rash, low blood pressure, high heart rate or rapid, shallow breathing, triggered by an overactive immune system, is, if a low grade, cause for celebration following CAR-T or bi-specific T cell therapies.
What is CRS or cytokine release syndrome (extra credit for using full words) .
Prevention of this issue is a cornerstone of the existence of the RBC team .
What is double billing .
Failing to obtain IRB approval before starting research is considered this.
What is noncompliance.
This major early 2000s research grant, awarded jointly to Holden and Mayo Clinic, supported groundbreaking work in lymphoma research.
What is the SPORE grant.
This federal law protects medical information used in research.
What is HIPAA.
This electronic order is used to instruct inpatient and outpatient nursing staff on the specifics needed to administer oncology non-oral medication to patients. Depending on the location of the patient at the time of consent, this is needed prior to OTA or after.
What is a beacon plan?
This uniform methodology of analyzing the items and services provided in a clinical research study, helps identify the appropriate payor for each study service, per federal agency guidelines.
What is the medicare coverage analysis .