View source for Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF

{{#set:
|HasDocument=Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025
|RefScope=G
|RefDocPart=Page 3 - CRF
|RefLanguage=EN
|RefTagsEN=
|RefTagsOriginal=
|RefTagsFR=
}}

== Document Information ==
{{:Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025}}

== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| G
|-
! scope="row" style="width:200px;" | Document part
| Page 3 - CRF
|-
! scope="row" style="width:200px;" | Language
| EN
|-
! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
|-
! scope="row" style="width:200px;" | Contributors
| 
|-
! scope="row" style="width:200px;" | Tags (EN)
| 
|-
! scope="row" style="width:200px;" | Tags (original language)
| 
|-
! scope="row" style="width:200px;" | Tags (FR)
| 
|-
! scope="row" | Comment
| CRFs used as source documents
|}

== Text ==
[...]
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.
[...]