Acronyms
What does the shorthand "c/o" in healthcare mean?
Complains of
What oral supportive therapy might be given to a patient who is anemic?
Iron supplement
Neoadjuvant
What is the CTCAE term that describes "Loss of appetite"?
Anorexia
What form do investigators and sub-investigators need to submit if they are listed on the 1572?
Financial Disclosure Form (FDF)
NED
What drug, starting with Z or O (generic name), is often prescribed alongside chemotherapy to prevent nausea and vomiting?
Zofran / Ondansetron
What is the generic name for Avastin?
Bevacizumab
Which adverse event term is used when there are low levels of all three blood cell types (red, white, and platelets)?
Pancytopenia
What does the IRB approval date link back to?
IRB Meeting / IRB Meeting date
UPIRTSO
Unanticipated Problems Involving Risks to Subjects or Others
What type of care focuses on relieving symptoms and improving the quality of life for cancer patients when curative or therapeutic treatment is no longer viable?
Palliative care
What class of chemotherapy has a common side effect of neuropathy?
Platinum-based Chemotherapies
What is the CTCAE term for this Grade 3 adverse event?
ANC <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour
Febrile neutropenia
What type of study staff update requires a COI ancillary review in eIRB?
Sub-I additions
PE (Hint - type of medical event)
Pulmonary Embolism
Drugs with these prefixes (-cef or -ceph) or these suffixes (-mycin, -cycline, -floxacin, -azole) belong to what drug classification?
Antibiotics
What therapy involves modifying a patient’s T cells to express a receptor that targets cancer cells?
CAR-T cell therapy
What 'law' or rule of thumb indicates whether a patient is at high risk of a fatal drug-induced liver injury?
The FDA set the following criteria: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of >3× the upper limit of normal (ULN); (2) total bilirubin (TBL) elevation of >2× ULN; (3) absence of initial findings of cholestasis (ie, absence of elevation of alkaline phosphatase [ALP] to >2× ULN); and (4) no other reason can be found to explain the combination of increased ALT and TBL, such as viral hepatitis A through E; other preexisting or acute liver disease; or another drug capable of causing the observed injury.
Hy's law
What type of eIRB submission would you need to complete if an SAE was deemed at least possibly related and unexpected?
Reportable New Information (RNI)
AUC (Hint - Carboplatin AUC 5)
area under the curve (a figure that reflects the concentration of a drug in the body that doctors want to achieve)
Dexamethasone is what kind of drug?
Corticosteroid (anti-inflammatory)
What type of drug blocks proteins that prevent the immune system from attacking cancer cells? (Hint - Pembrolizumab blocks PD-1)
Checkpoint inhibitors
What potentially life-threatening condition, often associated with CAR-T cell therapy, involves a massive release of cytokines into the bloodstream, leading to symptoms such as fever, low blood pressure, and organ dysfunction?
Cytokine Release Syndrome (CRS)
ISRU does not have a medical monitor. What entity could serve as a third-party reviewer for questions or concerns that would typically go to a medical monitor?
IRB