Computer Down
What are the columns of a dosing compliance computer down?
What are time and conditions.
What is one thing vitals computer prep will make you do?
What is answer questions, scan machine, perform an acquisition of temperature or BP on yourself.
What is the standard meal time for breakfast?
What is 30 minutes
What system is used to measure ECGs?
What is M12
How long are restrooms and dorms locked for dosing?
What information needs to be written on a lab tube when computer down?
When should the SpO2 device be taken off?
What is before saving data
What is the proper procedure to replace an SD card on a holter machine?
What is remove the batteries first, then remove the SD card
How many sheets are needed to prep for a dosing?
What is at least 2 copies of source data and 2 copies of the medication sheets
What is a time column, weight column(lbs), scale number, and title.
What is different about orthostatic vitals?
What is the difference between critical meals and content critical meals?
What is critical meals don't need to be eaten in their entirety, content critical meals do
What is the difference between Holter tab placement and ECG tab placement?
What is holter tabs differ in limb leads, they are placed on the torso instead
What is the medication being dosed called?
What is the investigational product (IP)
How many computer downs should be created for vitals?
What is it depends on the number of positions (3 positions- 3 computer downs)
What is different about Ginger vitals prep?
What is a spreadsheet and flowchart are needed
What happens if you forget to prep for meals?
What are fuzzy lines
What are the three sections required for the dosing in the spec
What are the test compounds, the FFAT, and the ACR.
What should the columns be on an ECG computer down?
What is there are no ECG computer downs
What are the celerion standard ranges for BP, HR, Respiration and SpO2?
What is BP: 90-155 (systolic), 40-95 (diastolic)
HR: 40-95
Respiration: 8-24
SpO2: 95-100%
A participant is showing you their tray after a content critical meal and everything besides their ketchup has been consumed. What do you do?
What is tell the participant to eat their ketchup. If refused, contact CSM.
What do you do if the holter extraction is disturbed?
What is document the time of start as well as when/how the disruption was resolved
What is the procedure for preparing water for the dosing event?
What is fill cups using a graduated cylinder