Requirements

• Blank set of CRFs, data collection sheets, and IRB-approved study questionnaires
• Refer to attached guidance to ensure appropriate source documentation: http://www.partners.org/phsqi/vrb/files/source%20documentation.doc

QI Tips/Additional Information

• Source documents are original recordings of subject or study data.
• Data collection sheets can act as source documentation.  For instance, during study visits, subject information is written directly onto worksheets. 
• An industry sponsor will usually provide CRFs to sites.  All protocol-required information is transferred from source documents onto CRFs.
• Annotated CRFs or data collection sheets are available on the QI website for Inclusion/Exclusion Criteria, Demographics, Medical History, Physical Exam, Con-meds, Labs, Adverse Events and Off Study Form: http://http://www.partners.org/phsqi/ToolsPage.htm