PowerPoint slide show on best practices for documenting raw data in GLP studies

1. 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
USAMRICD

2. 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
USAMRICD

4. A few GDP specifics
USAMRICD

5. Making data entries
• All handmade entries are written in indelible ink,
preferably blue or black
• If it can’t be read, it is not legible
• All data are reported
• Don’t “scrunch” data
– Avoid writing in borders or margins – use
additional paper
USAMRICD

6. 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)
USAMRICD

8. 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
USAMRICD

10. 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 you’re sloppy, slow down and print
• Don’t recopy data just to make it look “nice”
USAMRICD

11. 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
USAMRICD

13. 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
USAMRICD

14. Maintaining clarity
• No filling out data sheets at the end of the
day/week/month or “when time allows”
• Don’t 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
• Don’t use arrows or “ditto” marks
USAMRICD

16. 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
USAMRICD

17. Maintaining traceability
• All data sheets contain protocol # or unique
identifier
• Don’t 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)
USAMRICD

18. W t d yo
ha o u
think?

19. W t d yo
ha o u
think?

20. Ho a o thiso ?
w b ut ne

21. 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
USAMRICD

23. 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
Don’t allow for assumptions!
USAMRICD

24. 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
USAMRICD

26. 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.”
USAMRICD

27. 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. I’ll write 145 grams. That’s close
enough.”
USAMRICD

28. 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.”
USAMRICD

29. 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.”
USAMRICD

30. Bad documentation practice
• Destroying original data or voiding original data
without supporting documentation and proper
approval
– Example: “These lab results really look funky.
They can’t be right. I will just get a clean sheet
and start over. No need to keep that original
data.”
USAMRICD

31. 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 it’s
okay.”
USAMRICD

32. W t d yo
ha o u
think?

33. Where to go when you have questions
• ICD Intranet
– OrganizationOffice of Regulated
StudiesAnalytical Procedures
– OrganizationOffice of Regulated StudiesGeneral
Laboratory Procedures
– OrganizationOffice of Regulated StudiesQuality
Assurance Procedures
– OrganizationOffice of Regulated StudiesGLP
Forms
USAMRICD

35. 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
USAMRICD

37. Thank you!
USAMRICD