Guidelines for Lab Notebooks
The Medical College of Wisconsin Quality Improvement (QI) Program started in 2003. The purpose of the program is to provide feedback regarding the conduct of human subject research. QI provides feedback and information through many activities including routine reviews, for cause audits, and summaries of activities at other institutions as reported by federal agencies. Recipients of the feedback and other information include the MCW/FH investigators and study team members, and MCW/FH IRBs.
The IRB and QI Program are components of the Human Research Protection Program within the Office of Research. The QI Program provides checklists and assist with the creation and organization of regulatory files and subject files.
Specifically, the Regulatory File Checklist includes items that should be included in the investigator's regulatory study file for any study, in addition to additional items required for an FDA-governed study.
As the study coordinator, what can I do to ensure that my study subject files and regulatory files are complete?
Know your protocol, make checklists for the subject files based on the procedures of the study and applicable visit schedule, etc. Create a system to maintain current and complete regulatory, and if applicable, study subject files and train the study staff on the maintenance and use of the system. Use the template checklists on QI’s website and review your files for the appropriate contents.