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Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF: Difference between revisions

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|tags=TAG-00124-Cas-PrΓΌ ++ TAG-00150-Sou-eUr ++ TAG-00033-Pro-oto
== Document Information ==
|tags_display=[[Glossary:TAG-00124-Cas-PrΓΌ|Case report form]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
{{:Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025}}
|comment=CRFs used as source documents
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|content=[...]
== Reference Details ==
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! scope="row" style="width:200px;" | Scope
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! scope="row" style="width:200px;" | Document part
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== Text ==
[...]
Case Report Forms Used as Source Documents
Case Report Forms Used as Source Documents


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Original CRFs used as source documents must be signed/initialed and dated (handwritten/or electronically, as applicable) by the individual recording the data to ensure a clear audit trail of who completed the document.
Original CRFs used as source documents must be signed/initialed and dated (handwritten/or electronically, as applicable) by the individual recording the data to ensure a clear audit trail of who completed the document.
[...]
[...]
}}

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 - CRF
Language EN
Original entry by Florian Adragna
Contributors
Tags Case report form, Source documents, Protocol

Content

[...] Case Report Forms Used as Source Documents

Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated in the protocol; however, it should not be general practice for all data collected during a clinical trial.

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.

Original CRFs used as source documents must be signed/initialed and dated (handwritten/or electronically, as applicable) by the individual recording the data to ensure a clear audit trail of who completed the document. [...]

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