Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note

Document information
Reference	USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025
Validity area	USA
Scope(s)	G
Document name	NIH - SCORE Manual: Appendix Source Documents Requirements
Version / Revision	Rev 01 16-Aug-2025
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual Appendix: Source Documentation Requirements
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
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Reference Details
Scope	G
Document part	Page 3 - Note
Language	EN
Original entry by	Florian Adragna
Contributors
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Comment	Direct entry vs. transcribed CRF data

Content

[...] Note: Using CRFs as source documents (direct and real-time entry) is different than using printed copies of electronic or paper CRFs as source documents, and then transcribing the data into the CRFs.

If the CRS uses copies of CRFs (paper or electronic) as source documents, such as a worksheet or template, and will then transcribe this data into the study CRF, the CRS can identify these CRFs to be used as source document worksheets or templates in the CRS procedures.

Clear documentation of which CRFs are being used as source documents should be readily available at the beginning of all monitoring visits. CRFs used as source documents must also be maintained and available for review in the same manner as other source documents.

Common Deficiencies • Inadequately identifying who corrected a document and when it was corrected (missing signature/initials, date), and failing to provide supporting notes to justify the change • Missing standard of care elements due to staff only focusing on study-specific CRF data/requirements • Study CRF being used as source document but not identified in the protocol to be used as such • Not following Good Documentation Practices (GDP) when making corrections (i.e., obliterating data, using pencil instead of pen) [...]