CA19

Prepping for Events

100

The first thing we look at to start our day?

What is a 'Personal Schedule' 

200

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

300

Buttons hit to obtain the SPEC for a study

what is 

F12>F10> and scroll down to 'print entire spec'

400

Core event does not require a Computer Down?

What is 

- ECG

500

A reason for calling your CCO before an event?

What is 

-15 minutes 'til event and they have not shown up yet.

Meals

100

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)

200

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

 

300

Study menus

What is 

Veeva >Celerion Quality>Celerion Enterprise

input "study # + menu" in search bar

400

Meals on dosing interval

What is 

Critical

- timed start/timed stop

- time start/no stop

500

Critical Meal; meal declined

What is 

they cannot decline for critical meals

Data Collection

100

Reason for hand-written data collecting

What is 

 - Computer Down 

200

Shortcut used to enter comments when correcting electronic data?

What is "<CTRL+O">

300

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.  

400

used to collect data for water restrictions

Dynamic eSource

500

Key principle that ensures that data is recorded in real-time (ALCOAC)

What is

(1st C) - 'Contemporaneous'

ShortKeys/Abbreviations

100

F10 

What is an Event Menu

200

PHL

What is a Phlebotomist 

300

F9

What is a 'Reject Tube'

400

IP

What is an Investigational Product

500

CSM

Clinical Study Manager 

ECGs

100

Open to start ECGs

What is M12A

200

What locations are V1 & V2 TABS placed?

What is the '4th intercoastal space' (between the 4th and 5th rib) 

300

Flowsheet requirements

What is 

-day

-timepoint

-database

-ranges

-before event

-after event

-position & duration

-spreadsheet (if specified) 

400

Database can be found here

What is 

- in your event section [found in SPEC]

500

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'