Prepping for Events
The first thing we look at to start our day?
What is a 'Personal Schedule'
Record Start/Stop do not need
What is
- to be distributed on the dosing interval
- no restriction on time (unless you have an event to go to)
What is
- Computer Down
F10
What is an Event Menu
Open to start ECGs
What is M12A
DAILY DOUBLE
(see questions on following slide)
Question: Location of the timepoint?
(answer below)
What is the T/E
Clinical Research>Reports>T/E Schedule>T/E Reports
select Option 2
Event screen set-up
What is
Clinical Research>Operations>BarCoding>Electronic Labels>Meals>F10> and scroll down to 'prepare for meals'
* Type in Study info and Select Event
Shortcut used to enter comments when correcting electronic data?
What is "<CTRL+O">
PHL
What is a Phlebotomist
What locations are V1 & V2 TABS placed?
What is the '4th intercoastal space' (between the 4th and 5th rib)
Buttons hit to obtain the SPEC for a study
what is
F12>F10> and scroll down to 'print entire spec'
Study menus
What is
Veeva >Celerion Quality>Celerion Enterprise
input "study # + menu" in search bar
Correction placement on Handwritten Source Data paper; when multiple pages
What is
- corrections are done in the footnote of the page where corrections have been made.
F9
What is a 'Reject Tube'
Flowsheet requirements
What is
-day
-timepoint
-database
-ranges
-before event
-after event
-position & duration
-spreadsheet (if specified)
Core event does not require a Computer Down?
What is
- ECG
Meals on dosing interval
What is
Critical
- timed start/timed stop
- time start/no stop
used to collect data for water restrictions
Dynamic eSource
IP
What is an Investigational Product
Database can be found here
What is
- in your event section [found in SPEC]
A reason for calling your CCO before an event?
What is
-15 minutes 'til event and they have not shown up yet.
Critical Meal; meal declined
Key principle that ensures that data is recorded in real-time (ALCOAC)
What is
(1st C) - 'Contemporaneous'
CSM
Clinical Study Manager
DOUBLE JEOPARDY
(see question on following slide)
QUESTION: Celerion Standards for QTc?
(see answer below)
What is '>470 for Females'
What is '>460 for Males'