ALCOA Essentials
Which element identifies the recorder?
Attributable - Link work to person
What support study conclusions?
Raw data
How do you note a data error?
One single line through the error
Name as least one prohibited correction method
Whiteout, erasers, overwriting
Recorded when the task occurs or data is first noted?
Contemporaneous - Record as performed
How should handwritten data be captured?
Record directly, promptly, legible in indelible ink
What must retain readable after correction?
The original entry stays readable
Which forms are a common GDP error?
Outdated or uncontrolled forms
What is meant by first information capture?
Original - Preserve first capture
What should accompany data entries?
Data should include entry data plus signature or initials
What accompanies a corrected entry?
Reason for correction, initials of person making the correction, & correction date
Which ensures timely data review?
Timely quality control practices
Which attribute rejects rounded values?
Accurate - Record actual instrument values
What should transcription retain?
Keep original raw data with record
When should a footnote by used and where should it be located?
When adjacent space is insufficient near the error, must remain on the same page
Electronic record changes require what traceability?
A retrievable audit trail and reason