Look at Picture # 1
Best description of placement of tamper-seal
What is "vertically centered"?
100
Global methods must be used at all sites per SOP
What is "false"?
100
Parallel to the top or bottom edge
What is "Horizontal?"
100
Look at Picture #1
What is "unblinding"? Tamper seal placement inconsistent.
100
All treatment groups are manufactured in the same operation so compare patient packs directly.
What is Blinding Type 1?
200
Look at Picture #2
Best description of the placement of label
What is "vertically centered"?
200
Visually identical products are items which can not be distinguished from each other, but may still have subtle differences that are difficult to easily notice.
What is FALSE?
200
Completely even with another surface
What is "Flush"?
200
Look at Picture #2
What is "unblinding"? Label placement inconsistent.
200
Sample is retained and used for direct comparison with subsequent operations.
What is Blinding Type 3?
300
Look at Picture #3
Best description of placement of tamper seal.
What is "Place the tamper seal on the bottom of the carton centered horizontally as shown"?
300
Visually identical products can NOT be issued to the Production room at the same time but visually similar products can as long as you keep them on opposite sides of the room.
What is FALSE?
300
To move the end of the label so that it is no longer coiled around a bottle but is straight
What is "unwound"?
300
Look at Pictures #3 and #4.
What is "blinding"? Correct label placement to cover all text.
300
Patient kit from the first operation is compared to a patient kit in another output.
What is Blinding Type 2?
400
Look at Picture #4
Best and most complete description of placement of label
What is "Apply kit label, Label Code IDKY, to the front of the carton, flush with the lower left corner"?
400
Products that are clearly visually distinguishable from each other may be issued to the room at the same time for processing in a single step.
What is TRUE?
400
*****DOUBLE JEOPARDY*****
Pre-printed text or image that changes location from product to product
What is "floating"?
400
Look at Picture #5.
What is "unblinding"? Bottle caps are different!
400
*****DOUBLE JEOPARDY*****
When Digital photos from initial treatment group required.
What is "when the material and labels are not available to produce a dedicated blinding sample?"
500
Look at Picture #5
Best description of placement of label
What is "vertically centered to the front of the carton and flush with the front left edge"?
500
See Picture #1 .
The type of product illustrated in picture would require a staged build.
What is TRUE?
500
The area which allows the pharmacist to see contents inside of a glass vial or other container
What is a "viewing window"?
500
Look at Pictures #6 and #7.
What is "unblinding"? Floating key.
500
Unique reference number format for templates and blinding samples.
What is “DU” – Almac Clinical Services site
“REF” – Reference
“10” – Current year
“0001” – Sequential number
DUREF1600001