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Data Collection

Blank set of case report forms (CRFs), data collection sheets and or study questionnaires

Refer to attached guidance to ensure appropriate source documentation

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.
If documents are filed electronically, write a signed and dated note to file indicating the location.
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.
Regulations/Guidelines: 21 CFR 312