Good Documentation Practices - FDA Reference

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unable to find the original document of following reference from FDA...
?The Facts About Source Documents" Stan W. Woollen, Deputy Director, Division of Scientific Investigations in June 199

Ensure ALCOA* to achieve data quality.
1. Attributable: is it obvious who wrote it?
- Who entered the data?
- Audit trail!

2. Legible: can it be read?
- Electronic data & metadata in human-readable form
- Modifications should not obscure prior entries
- Audit trail!

3. Contemporaneous: is the information current and in the correct time frame?
- The time of data entry into the ...form ...should be close proximity to the time of ...activity.
- Audit trail!

4. Original: is it a copy; has it been altered?
- Earliest record
- Changes and / or corrections should not obscure prior entries.
- Audit trail!

5. Accurate: are conflicting data recorded elsewhere?
- valid representation of the source data.
- Corrections should be documented.
- Quality control measures / processes.
- Audit trail!
http://www.fda.gov/downloads/training/guidancewebinars/ucm383657.pdf

http://www.mtnstopshiv.org/sites/default/files/attachments/SourceDocSOPv2.pdf

thought of sharing the same and getting lucky to trace the original document,...
 
I

isoalchemist

That was shared at a conference so I'm not sure it will be easy to get at.

The Facts About Source Documents” by Stan W. Woollen, Presented at the 1999 DIA Annual Meeting
 
M

MIREGMGR

Mr. Woollen was at FDA for 29 years, retiring in 2006. Per his LinkedIn info, he's currently a consultant with his own firm, Stan Woollen and Associates.

Perhaps you could contact him directly through LinkedIn or Facebook, and ask if the original guidance was published.

Or, you could hire him as a consultant, or through the speaker bureau that represents him.
 

v9991

Trusted Information Resource
Perhaps you could contact him directly through LinkedIn or Facebook, and ask if the original guidance was published.

Or, you could hire him as a consultant, or through the speaker bureau that represents him.

Yes that is a good idea, but interesting point to note is that,

i got the reference to the above document from internet-forum, directing to a fda-page; (its not available anymore...)
fda.gov has other ppts referring/citing the above document, (like the ones i quoted above) but original doc is missing!?)
 
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Ronen E

Problem Solver
Moderator
Yes that is a good idea, but interesting point to note is that,

i got the reference to the above document from internet-forum, directing to a fda-page; (its not available anymore...)
fda.gov has other ppts referring/citing the above document, (like the ones i quoted above) but original doc is missing!?)

It's not uncommon for the FDA to remove content from its website, even if parts of it are still utilized somewhere else in the system.
 
C

channelr

good documentation practices- hello can anyone tell me is is acceptable to just initial and date after a writing error, or do you need to spell out your entire name? Any help is appreciated!!!! THANKS!
 

v9991

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good documentation practices- hello can anyone tell me is is acceptable to just initial and date after a writing error, or do you need to spell out your entire name? Any help is appreciated!!!! THANKS!
Yes, you could use initial (/ short signature), if the same is recorded in the GMP documentation. (usually, its recorded&maintained through 'specimen signatures' of all concerned)

if corrections are made in real time, (immediate corrections), its common practice to write a initial&date, ( reviewer could comment on correction, if required)
if corrections are made after completion of activity (considerable time lapse, or viz., after reviewer), then it is appropriate to go through appropriate procedure. ( viz., ratification procedure, if nothing is affected, or a proper deviation/incident mechanism)
 
C

channelr

When would the reason of the error be documented (ie: Mistake) versus maybe a line through the word spelled wrong and then spell the word accurately? Thank you!
 

v9991

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When would the reason of the error be documented (ie: Mistake) versus maybe a line through the word spelled wrong and then spell the word accurately? Thank you!

typo errors definitely wont need to be any further justified, (they are too obvious, UNLESS they are implying exact or opposite meaning) (not/note, whole/partial, and more functional words which are loosely used, recommended/approved vs not approved/recommended etc)

as a principle, any correction done after completion of activity shall accompany a reason / justification for authenticity of updated value. (through a formal correction/ratification format and approval procedures, where appropriate)
 
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