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Good Documentation Practice

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

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Good Documentation Practice

  1. 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. 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. 3. A few GDP specifics USAMRICD
  4. 4. 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
  5. 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. 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. 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 you’re sloppy, slow down and print • Don’t recopy data just to make it look “nice” USAMRICD
  8. 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. 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. 10. 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
  11. 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. 12. 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
  13. 13. W t d yo ha o u think?
  14. 14. W t d yo ha o u think?
  15. 15. Ho a o thiso ? w b ut ne
  16. 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. 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 Don’t allow for assumptions! USAMRICD
  18. 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. 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. 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. I’ll write 145 grams. That’s close enough.” USAMRICD
  21. 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. 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. 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 can’t be right. I will just get a clean sheet and start over. No need to keep that original data.” USAMRICD
  24. 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 just initial for Mike. I know it’s okay.” USAMRICD
  25. 25. W t d yo ha o u think?
  26. 26. 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
  27. 27. 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
  28. 28. Thank you! USAMRICD

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