CRC Basic 2.0 Study Documentation
Good, Better, Best and How to Reach the Top
When to start?
12
4 3
Phases of Documentation
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
Recognizing -Good -Better-Best
Informed Consent
Source Docs
Notes to file and other
documen-tation
StudyDocumentation
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
Scribble over
mistake
White out
mistake
Write over
mistake
Back date note
Corrections
Single line
through
Correct data
Today’s date & initials
Brief Reason
Corrections
Corrections
Study Documentation
Resources for checklists– http://www.partners.org/phsqi/Tools
Page.htm– http://www.partners.org/phsqi/vrb/fi
les/index.htm
References
1. http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133749.pdf
2. http://tjkuhn.wordpress.com/2008/07/23/alcoa/3. http://www.partners.org/phsqi/ToolsPage.htm4. http://www.partners.org/phsqi/vrb/files/index.htm
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