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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
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DURING THE COVID-19 (CORONAVIRUS) PANDEMIC  v5
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== References ==
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! Reference !! Scope !! Document part !! Language !! Preview
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| [[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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Latest revision as of 14:15, 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 […]

- …
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