CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top.
-
Upload
josie-levick -
Category
Documents
-
view
220 -
download
2
Transcript of CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top.
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