Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note: Difference between revisions
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| | |has_document=Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 | ||
| | |module=4 | ||
| | |unit=4.2.2 | ||
| | |scope=G | ||
| | |doc_part=Page 3 - Note | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00124-Cas-PrΓΌ ++ TAG-00150-Sou-eUr ++ TAG-00064-Ele-eUn ++ TAG-00033-Pro-oto | ||
|tags_display=[[Glossary:TAG-00124-Cas-PrΓΌ|Case report form]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00064-Ele-eUn|Electronic records]], [[Glossary:TAG-00033-Pro-oto|Protocol]] | |||
Β | |comment=Direct entry vs. transcribed CRF data | ||
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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. | 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. | ||
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β’ Not following Good Documentation Practices (GDP) when making corrections (i.e., obliterating data, using pencil instead of pen) | β’ Not following Good Documentation Practices (GDP) when making corrections (i.e., obliterating data, using pencil instead of pen) | ||
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Latest revision as of 13:50, 16 July 2026
| 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 |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 β Unit 4.2.2 |
| Scope | G |
| Document part | Page 3 - Note |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Case report form, Source documents, Electronic records, Protocol |
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 β’ 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 β’ Missing standard of care elements due to staff only focusing on study-specific CRF data/requirements β’ Study CRF being used as source document but not identified in the protocol to be used as such β’ Not following Good Documentation Practices (GDP) when making corrections (i.e., obliterating data, using pencil instead of pen) [...]
