Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF
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| 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 â 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. [...]
