Approved Error Codes and Use
IC
What is an Incorrect Calculation?
This refers to the completeness, consistency, and accuracy of data.
What is data integrity?
A substance used to obliterate recorded data.
What is white out?
02NOV2020
What is the correct date format?
Labels attached to documents must have this.
What is a score mark?
LEVB
What is late entry verified by?
Complete, consistent, and accurate data should be attributable, legible contemporaneously recorded, original or a true copy, and accurate is remembered with this acronym.
What is ALCOA?
Entering a date that is not the current date
What is back dating or post dating?
The first step in writing a footnote.
What is a sequential number?
Score marks must also include this.
What is an initial and date?
This can not be used for approved GMP documents.
What is WC? - Worksheet Correction?
Measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.
What is Good Documentation Practices (GDP)?
A typographic symbol indicating that words or figures above it are to be repeated.
What is a ditto mark?
The second step in writing a footnote
What is a circle?
This must also happen to thermal paper print-outs.
What is a photocopy?
These are acceptable corrections that can be made without a reason code.
What are same day changes?
spelling errors?
write overs?
illegible entries?
Blanks?
Wrong dates
Information based on facts that can be proved through a documented measurement, observation, or test that show or prove that something exists
or is true.
What is objective evidence?
A printed form without a watermark
What is an uncontrolled copy?
This happens after completing the footnote.
What is an initial and date?
This can not be done while attaching print-outs to a document.
What is obscuring data?
This person can make changes/corrections to the documentation if the originator is unavailable.
Who is the supervisor, study director, or study specialist?
Record raw data directly into laboratory notebooks or onto controlled forms, as appropriate, is known as this.
What is concurrent documentation?
Unused area on a page.
What is a "NA"?
You do this to correct an error in a footnote.
What is a single line out?
Attachments must contain this information.
What is the appropriate identifying number?
LIMS, sample number, test code, initial date