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United States Army Medical Research and Materiel Command
United States Army Medical Research Institute of Chemical Defense
GOODGOODDOCUMENTATION PRACTICEDOCUMENTATION PRACTICE
Office of Regulated StudiesOffice of Regulated Studies11 February 200911 February 2009
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What is the purpose of GDP?What is the purpose of GDP?• Ensures reliable, consistent transfer of Ensures reliable, consistent transfer of
informationinformation• Fulfills the basic premise that good science is Fulfills the basic premise that good science is
reproducible reproducible • Helps preclude dishonesty and fraudHelps preclude dishonesty and fraud• Essential for producing quality resultsEssential for producing quality results• Helps maintain:Helps maintain:
– AccuracyAccuracy– ClarityClarity– TraceabilityTraceability
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A few GDP specificsA few GDP specifics
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Making data entriesMaking data entries• All handmade entries are written in indelible ink, All handmade entries are written in indelible ink,
preferably blue or blackpreferably blue or black• If it can’t be read, it is not legibleIf it can’t be read, it is not legible• All data are reportedAll data are reported• Don’t “scrunch” dataDon’t “scrunch” data
– Avoid writing in borders or margins – use Avoid writing in borders or margins – use additional paperadditional paper
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Making data entriesMaking data entries• All abbreviations are explainedAll abbreviations are explained• Unusual responses noted and reportedUnusual responses noted and reported• Record what is meaningful; leave off the restRecord what is meaningful; leave off the rest• Entries are made immediately or as soon as Entries are made immediately or as soon as
possible after they occur possible after they occur
The FDA considers “immediately” to mean The FDA considers “immediately” to mean “within 24 hours”“within 24 hours” (Q & A with the FDA, 2003)(Q & A with the FDA, 2003)
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Making correctionsMaking corrections• Any changes to GLP records are done in a Any changes to GLP records are done in a
manner that does not render the original entry manner that does not render the original entry illegibleillegible
• Do not write over a number or letter to correct itDo 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 8Do not try to make a 5 into a 6 or a 6 into an 8
The use of pencils, White Out®, Post-It® Notes The use of pencils, White Out®, Post-It® Notes or correction tape is unacceptableor correction tape is unacceptable
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Making correctionsMaking corrections• The error maker should be the one to correct The error maker should be the one to correct
the errorthe error– If that person cannot be found, then If that person cannot be found, then
management approval is required for the management approval is required for the correctioncorrection
• If you’re sloppy, slow down and printIf you’re sloppy, slow down and print• Don’t recopy data just to make it look “nice”Don’t recopy data just to make it look “nice”
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Making correctionsMaking corrections• Draw a single line through item to be correctedDraw a single line through item to be corrected• Place your initials next to the corrected itemPlace your initials next to the corrected item• Add date of correctionAdd date of correction• State reason for correctionState reason for correction
RE: recording error SE: spelling errorRE: recording error SE: spelling errorTE: technical error LE: late entryTE: technical error LE: late entryDE: dosing error WD: wrong dateDE: dosing error WD: wrong dateCE: calculation error TRE: transcription errorCE: calculation error TRE: transcription errorMI: malfunctioning instrumentMI: malfunctioning instrument
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Maintaining accuracyMaintaining accuracy
• Balance values recorded as displayed and Balance values recorded as displayed and rounded laterrounded later
• No documentation by exceptionNo documentation by exception• Numbers recorded to the appropriate Numbers recorded to the appropriate
significancesignificance• If estimating, so designateIf estimating, so designate• If multiple measuring devices are employed, If multiple measuring devices are employed,
use the significance of the least critical device use the significance of the least critical device
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Maintaining clarityMaintaining clarity• No filling out data sheets at the end of the No filling out data sheets at the end of the
day/week/month or “when time allows”day/week/month or “when time allows”• Don’t leave blank or “white” spaces in forms Don’t leave blank or “white” spaces in forms
and documentationand documentation– Mark through with a line or use “N/A”Mark through with a line or use “N/A”– Blank spaces need clarification so no one can Blank spaces need clarification so no one can
come back and insert data “after the fact”come back and insert data “after the fact” • Document corrective actionsDocument corrective actions• Don’t use arrows or “ditto” marksDon’t use arrows or “ditto” marks
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Maintaining traceabilityMaintaining traceability• Data recorded onto appropriate forms or into Data recorded onto appropriate forms or into
appropriate logsappropriate logs• Place extraneous observations in notes or on a Place extraneous observations in notes or on a
supplemental formsupplemental form• If data is transcribed, so stateIf data is transcribed, so state
– Reference the original sourceReference the original source– Include photocopy of original or source Include photocopy of original or source
whenever possiblewhenever possible– Photocopy must be audited and verifiedPhotocopy must be audited and verified
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Maintaining traceabilityMaintaining traceability
• All data sheets contain protocol # or unique All data sheets contain protocol # or unique identifieridentifier
• Don’t forget to sign and/or initial and date Don’t forget to sign and/or initial and date where requestedwhere requested– If data is recorded by a different individual If data is recorded by a different individual
than the one performing the procedure or task, than the one performing the procedure or task, identify both persons on the data form(s)identify both persons on the data form(s)
What do you What do you think?think?
What do you What do you think?think?
How about this one?How about this one?
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Statistics and calculationsStatistics and calculations• Describe all calculations and formulasDescribe all calculations and formulas• Describe statistical methodsDescribe statistical methods
– Test them and document such testingTest them and document such testing• Distinguish between raw and corrected dataDistinguish between raw and corrected data• Rejection or reanalysis of data pointsRejection or reanalysis of data points
– Accompanied by scientifically valid reasonsAccompanied by scientifically valid reasons– Outlier tests conductedOutlier tests conducted– Reported but excluded from analysisReported but excluded from analysis
• Values averaged or otherwise identifiedValues averaged or otherwise identified
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Computer software Computer software
If raw data are collected and manipulated by a If raw data are collected and manipulated by a software program, so statesoftware program, so state– Explain how the software manipulates dataExplain how the software manipulates data– Reference software validation recordsReference software validation records
• The use of computer software in GLP research The use of computer software in GLP research comes with its own set of requirementscomes with its own set of requirements– The “Electronic Rule,” 21 CFR 11The “Electronic Rule,” 21 CFR 11
Don’t allow for assumptions!Don’t allow for assumptions!
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Significant figuresSignificant figures
• What is a “significant figure”?What is a “significant figure”?• How does one go about deciding which figure How does one go about deciding which figure
is significant?is significant?• Significant figures in complex calculations and Significant figures in complex calculations and
formulasformulas• Significant figures in calculators and Significant figures in calculators and
spreadsheetsspreadsheets
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Bad documentation practiceBad documentation practice
• Entering data results when testing has not been Entering data results when testing has not been performedperformed– Example: “I never see sick animals during Example: “I never see sick animals during
observation periods. I will just write down that observation periods. I will just write down that all animals appeared normal.”all animals appeared normal.”
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Bad documentation practiceBad documentation practice
• Entering data results which are not reflective of Entering data results which are not reflective of the actual observationthe actual observation– Example: “Gee, the body weight is supposed to Example: “Gee, the body weight is supposed to
be between 120 and 145 grams, but its’ 148 be between 120 and 145 grams, but its’ 148 grams. I’ll write 145 grams. That’s close grams. I’ll write 145 grams. That’s close enough.”enough.”
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Bad documentation practiceBad documentation practice
• Signing for work prior to that work being Signing for work prior to that work being performedperformed– Example: “I am going on break at 10 AM and Example: “I am going on break at 10 AM and
have an observation check due. So, I will just have an observation check due. So, I will just write the 10 AM check in on my documentation write the 10 AM check in on my documentation now (9:40 AM), and therefore I can still have a now (9:40 AM), and therefore I can still have a break at 10 AM.”break at 10 AM.”
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Bad documentation practiceBad documentation practice
• Entering a date other than the current date Entering a date other than the current date when documenting completion of a task or when documenting completion of a task or commentcomment– Example: “Oops, I forgot to write in that date for Example: “Oops, I forgot to write in that date for
the results I took 3 weeks ago. I know I did it, the results I took 3 weeks ago. I know I did it, but just forgot to put the darn date. I will just but just forgot to put the darn date. I will just backdate it.”backdate it.”
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Bad documentation practiceBad documentation practice
• Destroying original data or voiding original data Destroying original data or voiding original data without supporting documentation and proper without supporting documentation and proper approvalapproval– Example: “These lab results really look funky. Example: “These lab results really look funky.
They can’t be right. I will just get a clean sheet They can’t be right. I will just get a clean sheet and start over. No need to keep that original and start over. No need to keep that original data.”data.”
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Bad documentation practiceBad documentation practice
• Verifying a step, task, calculation or other entry Verifying a step, task, calculation or other entry without individual observationwithout individual observation– Example: “Gee whiz, Mike left me alone to add Example: “Gee whiz, Mike left me alone to add
these ingredients to the blender. It calls for him these ingredients to the blender. It calls for him to verify me doing this. Oh well, I have been to verify me doing this. Oh well, I have been doing this for 3 months and never made a doing this for 3 months and never made a mistake. I will just initial for Mike. I know it’s mistake. I will just initial for Mike. I know it’s okay.”okay.”
What do you What do you think?think?
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Where to go when you have questions Where to go when you have questions • ICD IntranetICD Intranet
– \Organization\Office of Regulated Studies\\Organization\Office of Regulated Studies\Analytical ProceduresAnalytical Procedures
– \Organization\Office of Regulated Studies\General \Organization\Office of Regulated Studies\General Laboratory ProceduresLaboratory Procedures
– \Organization\Office of Regulated Studies\Quality \Organization\Office of Regulated Studies\Quality Assurance ProceduresAssurance Procedures
– \Organization\Office of Regulated Studies\GLP \Organization\Office of Regulated Studies\GLP FormsForms
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Where to go when you have questions Where to go when you have questions
• Office of Regulated Studies, E3100 room 11Office of Regulated Studies, E3100 room 11– CPT Jennifer Evans, GLP Compliance Officer CPT Jennifer Evans, GLP Compliance Officer
Phone: 5-1727; E-mail: Phone: 5-1727; E-mail: [email protected]@us.army.mil
– Connie Clark, Quality Assurance Specialist Connie Clark, Quality Assurance Specialist Phone: 5-1830; E-mail: Phone: 5-1830; E-mail: [email protected]@us.army.mil
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Thank you!Thank you!