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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

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

A few GDP specifics USAMRICD .

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

2003) USAMRICD . 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. Making data entries • All abbreviations are explained • Unusual responses noted and reported • Record what is meaningful.

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White Out®. Post-It® Notes or correction tape is unacceptable USAMRICD . 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.

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Making corrections • The error maker should be the one to correct the error – If that person cannot be found. slow down and print • Don’t recopy data just to make it look “nice” USAMRICD . then management approval is required for the correction • If you’re sloppy.

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 .

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

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 .

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so state – Reference the original source – Include photocopy of original or source whenever possible – Photocopy must be audited and verified USAMRICD . 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.

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 .

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 USAMRICD .

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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 . Computer software If raw data are collected and manipulated by a software program.

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 .

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

I’ll write 145 grams. Bad documentation practice • Entering data results which are not reflective of the actual observation – Example: “Gee.” USAMRICD . That’s close enough. the body weight is supposed to be between 120 and 145 grams. but its’ 148 grams.

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. I will just write the 10 AM check in on my documentation now (9:40 AM). So. and therefore I can still have a break at 10 AM.” USAMRICD .

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

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

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

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 USAMRICD .

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mil – Connie Clark.Where to go when you have questions • Office of Regulated Studies.mil USAMRICD . E-mail: connie.clark1@us. E3100 room 11 – CPT Jennifer Evans. E-mail: jennifer.army. Quality Assurance Specialist Phone: 5-1830.evans1@us. GLP Compliance Officer Phone: 5-1727.army.

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Thank you! USAMRICD .