External Access to Monitors

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    • #6951

      As you know we are treating patients with life threatening conditions and want to go on accessing trial treatments for them. We have prioritised trials and will not recruit to trials where the risk of exposure to the plague outweighs the possible benefit to the participants.

      We cannot have external visitors to the site, so monitors cannot attend and perform Source Document Verification of patient records against the recorded data.  A sponsor has stopped us recruiting to a trial because we cannot offer external access to patient electronic Medical Record (EMR).

      We have offered other ways of external review such as printing and de-identifying EMR reports and results, but it is against the sponsor’s principles.

      So, what is the opinion on external access to electronic medical records, and has anyone else had this similar experience above?

      I understand that site docs is a good platform in sharing information via external access to monitors, but can I understand further what are the methods/safety measures in place to share information but not compromising on patient confidentiality?

    • #7026

      Hi AMaRC. Unfortunately, in the circumstance you have described , if the Sponsor is not prepared to review the data despite your attempts to permit access, you are stuck.
      Have you had a conversation to discuss why this is not possible?
      What is the risk they are trying to manage internally?
      Do you have institutional permission to share these records? If yes, have you supplied the sponsor with evidence of this permission?
      I would suggest first making sure you fully understand what the barriers are and then try to address them with documented evidence of levels of permission. Good luck.

    • #7027

      One of the regional trial sites is utilising “TeamViewer” to provide secure access to the Electronic Medical Records during the lock-down. This application allows remote access for the monitors using a unique ID and password that only can only be used once and access is blocked at the end of the day.

      SiteDocs is widely used across the regional network and provides the monitors with centralised monitoring of the Investigator Site Files. For older trials that are not on SiteDocs this cannot be done and other ways of source data verification have to be agreed with the sponsor.

      Hope that’s helpful

    • #7159

      I’m seeing a lot more Sponsors doing only very limited SDV, in preference for Centralised Monitoring as part of Risk Based Data Monitoring. The idea is that it’s better at identifying important data issues.

      Although this needs to be set up from the start so doesn’t help your current situation.

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