Abbreviations
DSMB
What is Data Safety Monitoring Board?
Person responsible for the overall conduct of the study.
What is the Principal Investigator?
Term for when blood pressure is too low.
What is Hypotension?
The protocol calls for brain imaging, which is most common CT Brain or MRI Brain?
What is MRI Brain?
Cancer known to be associated with BRCA.
What is breast cancer?
ADR
What is an Adverse Drug Reaction?
The study phase that observes the effectiveness of a drug.
What is Phase II?
Lab test that is used as a primary indicator of kidney function.
What is Creatinine Clearance (CrCl)?
Must be at least 1.5cm (shortest axis); measurable disease or malignant lymph nodes?
What is malignant lymph nodes?
Patient intermittently requires thoracenteses, which cancer do they most likely have?
What is lung cancer?
LAR
What is a Legally Acceptable Representative?
Document that's created in response to a deviation or safety concern, typically issued by the monitor.
What is a CAPA?
Combination of attributions for an SAE that warrants IRB and FDA reporting.
What is at least Possibly related and Unexpected?
Patient is transfused for Grade 2 anemia, is the anemia clinically significant (CS) or not clinically significant (NCS)?
What is clinically significant (CS)?
Cancer that utilizes the Lugano Classification rather than RECIST.
What is lymphoma or hematologic cancers?
SUSAR
What is a Suspected Unexpected Serious Adverse Reaction?
Document that a non-English speaker signs in lieu of an English ICF.
What is a Short Form?
Type of appointment a patient must have if getting their port accessed.
What is an infusion appointment?
A monitor is looking for the clinical staging of a patient, should they look in the pathology report or the physician's note?
What is the physician's note?
Cancer that utilizes a black ribbon.
What is melanoma?
UPIRTSO
What is an Unanticipated Problem Involving Risks to Subjects or Others?
Main guidelines to study when preparing for the ACRP exam.
What is the ICH Guidelines?
Value of hemoglobin that usually requires transfusion or holding drug.
What is hemoglobin less than 8.0 g/dL or Grade 3 anemia?
A reportable SAE would be submitted to the IRB via a RNI or Modification?
What is a RNI?
Second most fatal cancer.
What is colorectal cancer?