Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1
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 | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.3.4 |
| Scope | G |
| Document part | Annex 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Remote SDV, Source data verification, Trial participant, Training, Risk |
| Comment | Created to be valid during COVID-19 pandemic. |
Content
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 remote SDV process. […] - Site staff should inform each trial participant or designated legal representative and ensure that they do not object to the remote review of their records for trial purposes and document this process in the trial participant’s medical records. If a trial participant objects to remote review of their records, no remote SDV will occur for that trial participant. - Performance of remote SDV by the monitor may only occur in locations that prevent viewing by any unauthorised person, through a secure internet connection and on a computer appropriately protected against unauthorised access to the data. - Monitors should sign a written confidentiality agreement committing to securely destroy any copy of redacted documents, whether paper or electronic, as soon as they have been used for source data verification and committing not to make any copy (or recording in the case of video access) of any non-pseudonymised document. - If the agreed remote SDV process involves redaction by the site staff (pseudonymisation) of source records [...] - If the agreed remote SDV process involves a video review of records: [...] - If the agreed remote SDV process involves the site providing the monitor remote access to the site electronic medical record (EMR) system: [...] - It should not be possible to make local copies of trial participants' health records. Users should be aware of the automatic creation of temporary files on their computer when reviewing trial participant data, and should securely delete such files immediately after each source data verification session.
