Requirements
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: