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CRC Basic 2.0 Study Documentation

CRC Basic 2.0 Study Documentation. Good, Better, Best and How to Reach the Top. When to start?. 4. 3. 2. 1. Phases of Documentation. What does “best” look like?. “Adequate and accurate” “Ensure accuracy and completeness”.

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CRC Basic 2.0 Study Documentation

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  1. CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top

  2. When to start? 4 3 2 1

  3. Phases of Documentation

  4. What does “best” look like? • “Adequate and accurate” • “Ensure accuracy and completeness” http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133749.pdf

  5. Definitions • A-Who created record • L-Readable • C-Timely • O-First time written • A-Correct, “whole truth”

  6. Study Execution and ALCOA • Informed Consent Recognizing -Good -Better -Best Study Documentation • Source Docs • Notes to file and other documen-tation

  7. Informed Consent ⃝ Attributable ⃝ Legible ⃝ Contemporaneous ⃝ Original ⃝ Accurate

  8. Informed Consent ⃝ Attributable ⃝ Legible ⃝ Contemporaneous ⃝ Original ⃝ Accurate

  9. Informed Consent ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A

  10. Source Documenation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A

  11. Source Documentation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A

  12. Other Documentation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A

  13. Other Documentation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A

  14. Corrections

  15. Corrections • 

  16. Corrections

  17. Corrections

  18. Study Documentation • Resources for checklists • http://www.partners.org/phsqi/ToolsPage.htm • http://www.partners.org/phsqi/vrb/files/index.htm

  19. References • http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133749.pdf • http://tjkuhn.wordpress.com/2008/07/23/alcoa/ • http://www.partners.org/phsqi/ToolsPage.htm • http://www.partners.org/phsqi/vrb/files/index.htm

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