Good Documentation Practice

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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
  • 3. A few GDP specifics USAMRICD
  • 4. 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 USAMRICD
  • 5. 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
  • 6. 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
  • 7. 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 USAMRICD
  • 8. 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
  • 9. 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
  • 10. 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 USAMRICD
  • 11. 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
  • 12. 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) USAMRICD
  • 13. W t d yo ha o u think?
  • 14. W t d yo ha o u think?
  • 15. Ho a o thiso ? w b ut ne
  • 16. 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
  • 17. 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! USAMRICD
  • 18. 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
  • 19. 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
  • 20. 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. USAMRICD
  • 21. 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
  • 22. 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
  • 23. 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. USAMRICD
  • 24. 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 ju


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