This controversial topic has come to the fore again with the Medicines and Healthcare products Regulatory Agency’s (MHRA) publication of its guidance on access to electronic Health Records (eHR’s) in the UK (1).
To summarise the regulatory situation the Food and Drug Administration (FDA) and the MHRA are both accepting of remote Source Data Verification (SDV), whereas the European Medicines Agency (EMA) and local European Union regulatory authorities are not in favour. The EMA has allowed it under the exceptional circumstances of the current pandemic, but only as an emergency measure and under specific requirements. (2)
This presents a challenge for Sponsor organisations running international clinical trials and may well mean that monitoring plans will need to be different for different countries and regions.
Bearing this in mind this blog post is intended to summarise the key points of the MHRAs guidance.
- eHR systems should allow appropriate access to sponsor representatives, and if not currently set up for this need to be updated accordingly. Interim measures can be taken where necessary pending these updates.
- MHRA do not like printouts of eHRs being used for review by sponsor representatives
- Remote access to eHRs by monitors should be direct login access not via video call or screen sharing. If sites upload copies of eHRs to a secure portal for review these must be certified copies in line with ICH E6(R2)
- Use of secure portals for review should take into account the owner of the portal and the consequent need for redaction of information which could identify the participant
- Information on access to all participant records must be included in the Informed Consent documentation
- There are sections on eHR functionality and security measures required to allow limited, secure, controlled and monitored access for sponsor representatives
It will be interesting to see how this topic continues to be viewed by regulators and how attitudes, processes and systems adapt in future.
Do you have an opinion? Have you been involved in remote SDV? I’d love to hear your thoughts and experiences – please comment below.
1. MHRA guidance on access to electronic Health records by sponsor representatives in clinical trials
2. EMA guidance on management of clinical trials during the covid-19 pandemic