crc basic 2.0 study documentation good, better, best and how to reach the top
TRANSCRIPT
![Page 1: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/1.jpg)
CRC Basic 2.0 Study Documentation
Good, Better, Best and How to Reach the Top
![Page 2: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/2.jpg)
When to start?
12
4 3
![Page 3: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/3.jpg)
Phases of Documentation
![Page 4: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/4.jpg)
What does “best” look like?
“Adequate and accurate” “Ensure accuracy and completeness”
http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133749.pdf
![Page 5: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/5.jpg)
Definitions
A-Who created record L-Readable C-Timely O-First time written A-Correct, “whole truth”
![Page 6: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/6.jpg)
Study Execution and ALCOA
Recognizing -Good -Better-Best
Informed Consent
Source Docs
Notes to file and other
documen-tation
StudyDocumentation
![Page 7: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/7.jpg)
Informed Consent
- Attributable - Legible - Contemporaneous - Original - Accurate
![Page 8: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/8.jpg)
Informed Consent
- Attributable - Legible - Contemporaneous - Original - Accurate
![Page 9: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/9.jpg)
Informed Consent
- A - L - C - O - A
![Page 10: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/10.jpg)
Source Documenation
- A - L - C - O - A
![Page 11: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/11.jpg)
Source Documentation
- A - L - C - O - A
![Page 12: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/12.jpg)
Other Documentation
- A - L - C - O - A
![Page 13: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/13.jpg)
Other Documentation
- A - L - C - O - A
![Page 14: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/14.jpg)
Corrections
Scribble over
mistake
White out
mistake
Write over
mistake
Back date note
![Page 15: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/15.jpg)
Corrections
Single line
through
Correct data
Today’s date & initials
Brief Reason
![Page 16: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/16.jpg)
Corrections
![Page 17: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/17.jpg)
Corrections
![Page 18: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/18.jpg)
Study Documentation
Resources for checklists– http://www.partners.org/phsqi/Tools
Page.htm– http://www.partners.org/phsqi/vrb/fi
les/index.htm
![Page 19: CRC Basic 2.0 Study Documentation Good, Better, Best and How to Reach the Top](https://reader033.vdocuments.site/reader033/viewer/2022052509/56649c9b5503460f94959e6a/html5/thumbnails/19.jpg)
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