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Data Collection

Requirements

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

Refer to attached guidance to ensure appropriate source documentation

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. 

  • 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

Applicable GCP sections:

  • 8.3.14

  • 8.3.15

  • 4.9.3

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