Definitions
General Practices
Errors and Corrections
ALCOA Gone Awry
True or False
100
GDP
Good Documentation Practices
100
The only colors of ink allowed in the Sterility Testing Service.
Black and Blue
100
Which of these is NOT an approved error reason code?
CE, DE, EE, TE, WD
DE
100
Quincy has finished recording on a testing worksheet but the reviewing analyst can't tell the difference between his 1's and 7's.
Legible
100
It is okay to leave a space blank as long as you check the N/A box, and initial/date.
True
(As long as there is an N/A checkbox applicable to the space.)
200
ALCOA
Attributable, Legible, Contemporaneous, Original, and Accurate
200
The GDP SOP for the Sterility Testing Service.
STER-QSM-003
200
Which error code is used for this error?
6.8 / 2 = 4.1
CE (calculation error)
200
On a new FORM, there is a table to enter data but there is no box to record initials or signature.
Attributable
200
When correcting an error a footnote is not always required.
True
If there is space near the cross-out, the correction and error comment may be written there.
300
This is the prohibited practice of recording an earlier date instead of the current date.
Backdating
300
The golden rule of GDP.
If it wasn't written down, it didn't happen!
300
This error code may be used if the date format is incorrect.
WD (wrong date) or EE/RE
300
Dr. Gram is in a hurry to record staining results but does not have any forms nearby, so he writes the data on his glove for later transcription to the form.
Original
300
Bartholomew gets married and changes his last name to match his wife's. He is okay to start using his new initials on testing forms because his name has legally been changed.
False
He must fill out a new STER-FORM-023 with his new initials.
400
The term for an in-full copy of a record that has been verified to ensure it is an exact and complete copy of the original.
True copy
400
This is required when attaching a label or small printout to a testing worksheet.
Initials/date across one juncture. (Printouts also need to be taped down on all four sides)
400
What is wrong with this cross out?
Cross outs should be a single line so that the original entry is still legible.
400
While turning in GPT forms for review, Guinevere notices that she forgot to write the date prepared for B. subtilis. She quickly writes in last Monday's date, then hands the packet to the reviewer.
Contemporaneous
400
If a late entry is made, verification of the data accuracy is required to be documented.
True
A comment such as "Late entry. Transcribed from logbook LB-0099" clearly shows where the data came from.
500
The underlying requirements for GDP, as enforced by the Food and Drug Administration, are set forth in these regulations.
21CFR ยงยง 211 and 212
500
Ensure you are using the most current version of a document by doing this.
Search for it in MasterControl and verifying the effective date.
500
These 4 things are required when correcting an error.
Line-through incorrect entry, correct entry, error comment, and initials/date.
500
Archibald is recording observations of mice that were given "super caffeine". He wants to add credibility to his theory that it is safe, so he fudges the numbers to support his conclusion.
Accurate
500
Even if the same type of error is made by the same person on the same day, each error on a page must have a separate error comment.
False
The same footnote may be used.