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Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022: Difference between revisions

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DURING THE COVID-19 (CORONAVIRUS) PANDEMIC  v5

Revision as of 12:54, 16 July 2026


Document information
Reference EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS

DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022

Validity area EU
Scope(s) G
Document name GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS

DURING THE COVID-19 (CORONAVIRUS) PANDEMIC

Version / Revision v5

10-Feb-2022

Status Current
Document type Official recommendation
Language(s) EN
Description GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d)G11 d)ENd) Remote source data verification

[…] Remote SDV may be considered for trials: - involving COVID-19 treatment or prevention;

- investigating serious …
EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1GAnnex 1ENAnnex 1: Protection of trial participants’ rights during remote source data verification

[…] - A documented risk assessment should be performed […]

- …


References

Reference Scope Document part Language Preview
Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) G 11

d) || EN || d) Remote source data verification […] Remote SDV may be considered for trials: - involving COVID-19 treatment or prevention; - investigating serious or life-threatening conditions; - where the ...

Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 G Annex 1 EN Annex 1: Protection of trial participants’ rights during remote source data verification […] - A documented risk assessment should be performed […] - Site staff and monitors should be trained on the ...
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