United States Army Medical Research and Materiel Command

United States Army Medical Research Institute of Chemical Defense

GOOD
DOCUMENTATION PRACTICE
Office of Regulated Studies
11 February 2009

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 What is the purpose of GDP?
Ensures reliable, consistent transfer of
information
Fulfills the basic premise that good science is
reproducible
Helps preclude dishonesty and fraud
Essential for producing quality results
Helps maintain:
Accuracy
Clarity
Traceability

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 A few GDP specifics

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 Making data entries
All handmade entries are written in indelible ink,
preferably blue or black
If it cant be read, it is not legible
All data are reported
Dont scrunch data
Avoid writing in borders or margins use
additional paper

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 Making data entries
All abbreviations are explained
Unusual responses noted and reported
Record what is meaningful; leave off the rest
Entries are made immediately or as soon as
possible after they occur
The FDA considers immediately to mean
within 24 hours (Q & A with the FDA, 2003)

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 Making corrections
Any changes to GLP records are done in a
manner that does not render the original entry
illegible
Do not write over a number or letter to correct
it
Do not try to make a 5 into a 6 or a 6 into an 8

The use of pencils, White Out, Post-It Notes

or correction tape is unacceptable

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 Making corrections
The error maker should be the one to correct
the error
If that person cannot be found, then
management approval is required for the
correction
If youre sloppy, slow down and print
Dont recopy data just to make it look nice

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 Making corrections
Draw a single line through item to be corrected
Place your initials next to the corrected item
Add date of correction
State reason for correction
RE: recording error SE: spelling error
TE: technical error LE: late entry
DE: dosing error WD: wrong date
CE: calculation error TRE: transcription error
MI: malfunctioning instrument

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 Maintaining accuracy
Balance values recorded as displayed and
rounded later
No documentation by exception
Numbers recorded to the appropriate
significance
If estimating, so designate
If multiple measuring devices are employed,
use the significance of the least critical device

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 Maintaining clarity
No filling out data sheets at the end of the
day/week/month or when time allows
Dont leave blank or white spaces in forms
and documentation
Mark through with a line or use N/A
Blank spaces need clarification so no one can
come back and insert data after the fact
Document corrective actions
Dont use arrows or ditto marks

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 Maintaining traceability
Data recorded onto appropriate forms or into
appropriate logs
Place extraneous observations in notes or on a
supplemental form
If data is transcribed, so state
Reference the original source
Include photocopy of original or source
whenever possible
Photocopy must be audited and verified

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 Maintaining traceability
All data sheets contain protocol # or unique
identifier
Dont forget to sign and/or initial and date
where requested
If data is recorded by a different individual
than the one performing the procedure or task,
identify both persons on the data form(s)

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What do you
think?
What do you
think?
How about this one?
 Statistics and calculations
Describe all calculations and formulas
Describe statistical methods
Test them and document such testing
Distinguish between raw and corrected data
Rejection or reanalysis of data points
Accompanied by scientifically valid reasons
Outlier tests conducted
Reported but excluded from analysis
Values averaged or otherwise identified

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 Computer software
If raw data are collected and manipulated by a
software program, so state
Explain how the software manipulates data
Reference software validation records
The use of computer software in GLP research
comes with its own set of requirements
The Electronic Rule, 21 CFR 11
Dont allow for assumptions!

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 Significant figures
What is a significant figure?
How does one go about deciding which figure
is significant?
Significant figures in complex calculations and
formulas
Significant figures in calculators and
spreadsheets

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 Bad documentation practice
Entering data results when testing has not been
performed
Example: I never see sick animals during
observation periods. I will just write down that
all animals appeared normal.

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 Bad documentation practice
Entering data results which are not reflective of
the actual observation
Example: Gee, the body weight is supposed to
be between 120 and 145 grams, but its 148
grams. Ill write 145 grams. Thats close
enough.

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 Bad documentation practice
Signing for work prior to that work being
performed
Example: I am going on break at 10 AM and
have an observation check due. So, I will just
write the 10 AM check in on my documentation
now (9:40 AM), and therefore I can still have a
break at 10 AM.

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 Bad documentation practice
Entering a date other than the current date
when documenting completion of a task or
comment
Example: Oops, I forgot to write in that date for
the results I took 3 weeks ago. I know I did it,
but just forgot to put the darn date. I will just
backdate it.

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 Bad documentation practice
Destroying original data or voiding original data
without supporting documentation and proper
approval
Example: These lab results really look funky.
They cant be right. I will just get a clean sheet
and start over. No need to keep that original
data.

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 Bad documentation practice
Verifying a step, task, calculation or other entry
without individual observation
Example: Gee whiz, Mike left me alone to add
these ingredients to the blender. It calls for him
to verify me doing this. Oh well, I have been
doing this for 3 months and never made a
mistake. I will just initial for Mike. I know its
okay.

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What do you
think?
Where to go when you have questions
ICD Intranet
\Organization\Office of Regulated
Studies\Analytical Procedures
\Organization\Office of Regulated Studies\General
Laboratory Procedures
\Organization\Office of Regulated Studies\Quality
Assurance Procedures
\Organization\Office of Regulated Studies\GLP
Forms

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Where to go when you have questions

Office of Regulated Studies, E3100 room 11

CPT Jennifer Evans, GLP Compliance Officer
Phone: 5-1727; E-mail: jennifer.evans1@us.army.mil
Connie Clark, Quality Assurance Specialist
Phone: 5-1830; E-mail: connie.clark1@us.army.mil

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 Thank you!

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