Recently, the Spanish Data Protection Agency published a favourable response to the consultation on the possibility of remote monitoring of clinical trials with medicinal products during the pandemic, as an exceptional measure to ensure the continuity of the monitoring during the health crisis. This consultation was carried out within the framework of exceptional measures applicable to clinical trials to manage problems arising from the COVID-19 emergency established by the AEMPS (Spanish Agency of Medicines and Medical Devices) which are specified in the version from 29 June 2020 of the AEMPS Instruction Document for conducting clinical trials in Spain, available at this link.
These exceptional measures include remote monitoring, in which the AEMPS recommends that the sponsor update the trial monitoring plans prioritizing centralized monitoring and remote monitoring at the participating centres that does not involve overloading the staff of the centre and postponing source data verification as far as possible until the medical history can be accessed in person. The sponsor will agree these monitoring conditions with the participating centres and teams.
It should be noted that in accordance with the AEMPS Instruction Document, remote source data verification may only be used for clinical trials investigating the prevention or treatment of COVID-19, and for phase I of first-in-human trials and for all others investigating treatments for serious diseases with no therapeutic alternatives.
This verification will also be carried out with the safeguards and precautions indicated in the EU directives
and with the requirements established by the Spanish Data Protection Agency, and will therefore require the prior approval of each centre of the data protection officer of the centre, which will need to be properly documented. However, it will not require the prior approval of the Ethics Committees for investigation with medicinal products (CEIm) or the authorization of the AEMPS.
Meanwhile, the response of the Spanish Data Protection Agency implies that, as well as the requirements established by the AEMPS indicated in the previous paragraph, for these remote source data verifications an addendum to the contract must be signed between the sponsor and the centre where the trial is carried out which provides for the following:
i. That the centre where the trial is carried out enables the use of the remote access system;
ii. That source data verification is allowed as an alternative to face-to-face monitoring only in the context of the current health crisis;
iii. That remote verification is justified in cases where postponing source data verification may cause harm to participants;
iv. That the parties undertake to comply with the criteria established by the AEMPS as part of the excepcional measures applicable to clinical trials to manage problems arising from the COVID-19 emergency, including the approval by of the Data Protection Officer of the remote access system.
v. That the monitoring tasks will be carried out in accordance with standard working procedures and only information that is strictly necessary will be accessed, and in accordance with the measures implemented by the centre in terms of security protocols, assuming full liability in case of non-compliance.
In those cases in which the monitor is established as the data processor for the centre where the research is carried out, these commitments must also be recorded in an addendum to the treatment data processing agreement with this third party, since there is a modification of the processing conditions.
Regarding the security measures applicable to the remote connection system, we must mention the Farmaindustria document “Remote connection security protocol during clinical trial monitoring”,
which details the security controls that must be followed.
For more information
For any additional questions or clarifications you can contact the Ministry of Health DPO:
Tel.: 93 553 26 42 (9 am to 2 pm) – TEMPORARILY INACTIVE
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