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