CRC Basic 2.0 Study Documentation
This document outlines the essential phases of study documentation, emphasizing the concepts of "Good," "Better," and "Best." It delineates what quality documentation entails, including the importance of accuracy, completeness, and reliability in records. The ALCOA principles—Attributable, Legible, Contemporaneous, Original, Accurate—are highlighted as standards for effective documentation. This resource also provides links to useful checklists and materials for improving documentation practices across study execution, informed consent processes, and source documentation.
CRC Basic 2.0 Study Documentation
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Presentation Transcript
CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top
When to start? 4 3 2 1
What does “best” look like? • “Adequate and accurate” • “Ensure accuracy and completeness” http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133749.pdf
Definitions • A-Who created record • L-Readable • C-Timely • O-First time written • A-Correct, “whole truth”
Study Execution and ALCOA • Informed Consent Recognizing -Good -Better -Best Study Documentation • Source Docs • Notes to file and other documen-tation
Informed Consent ⃝ Attributable ⃝ Legible ⃝ Contemporaneous ⃝ Original ⃝ Accurate
Informed Consent ⃝ Attributable ⃝ Legible ⃝ Contemporaneous ⃝ Original ⃝ Accurate
Informed Consent ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A
Source Documenation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A
Source Documentation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A
Other Documentation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A
Other Documentation ⃝ A ⃝ L ⃝ C ⃝ O ⃝ A
Corrections •
Study Documentation • Resources for checklists • http://www.partners.org/phsqi/ToolsPage.htm • http://www.partners.org/phsqi/vrb/files/index.htm
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
