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

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

Reference Details
Module	Module 4 — Unit 4.3.4
Scope	G
Document part	11 d)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Remote SDV, Source data verification, Remote monitoring, Safety, Trial participant

Content

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 absence of SDV for critical data may likely pose unacceptable risks toparticipants’ safety or the reliability/integrity of trial results; - involving particularly vulnerable participants such as children or thosetemporarily (e.g. trials in emergency situations) or permanently (e.g. trials in patients with advanced dementia) incapable of giving their informed consent or - in pivotal trials. [...] In the case of these trials, principal investigators should make their own determination as to whether or not the situation at their clinical site allows any of the following options for remote SDV: - Sharing pseudonymised copies of trial related source documents with the monitor; this may be done electronically where manageable by the site staff; - Direct, suitably controlled remote access to trial participants’ electronic medical records; - Video review of medical records with clinical site team support, without sending any copy to the monitor and without the monitor recording images during the review. [...] Remote SDV can be carried out only in agreement with the investigators who should not be put under undue pressure to accept remote SDV and should always give priority to the care to be given to trial participants and other patients. Remote SDV should not be carried out if adequate data protection, including data security and protection of personal data even if pseudonymised, is not ensured. Refer to Annex 1 for controls that, where applicable, can protect trial participants’ rights while permitting remote SDV.