Virtual Regulatory Binder: Data Collection

Last revised: 


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

Refer to attached guidance to ensure appropriate source documentation

QIU 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: