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

2. When to start? 12 43

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 Recognizing -Good -Better -Best Informed Consent Source Docs Notes to file and other documen- tation Study Documentation

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 Scribble over mistake White out mistake Write over mistake Back date note

15. Corrections Single line through Correct data Today’s date & initials Brief Reason

16. Corrections

17. Corrections

18. Study Documentation  Resources for checklists – http://www.partners.org/phsqi/To olsPage.htm http://www.partners.org/phsqi/To olsPage.htm – http://www.partners.org/phsqi/vr b/files/index.htm http://www.partners.org/phsqi/vr b/files/index.htm

19. References 1.http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UC M133749.pdfhttp://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UC M133749.pdf 2.http://tjkuhn.wordpress.com/2008/07/23/alcoa/http://tjkuhn.wordpress.com/2008/07/23/alcoa/ 3.http://www.partners.org/phsqi/ToolsPage.htmhttp://www.partners.org/phsqi/ToolsPage.htm 4.http://www.partners.org/phsqi/vrb/files/index.htmhttp://www.partners.org/phsqi/vrb/files/index.htm