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

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Presentation on theme: "CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top."— Presentation transcript:

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” 

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 – olsPage.htm olsPage.htm – b/files/index.htm b/files/index.htm

19 References 1.http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UC M pdfhttp://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UC M 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


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