Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022
From GxPlex
| 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
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| 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 … |
| 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 […] - … |
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 ... |
