Remote Data Monitoring
Traditionally, industry sponsors have performed quality oversight responsibilities through on-site monitoring. This activity includes a combination of Source Data Verification (SDV) for accuracy as well as Source Data Review (SDR) for quality. To ensure safety during the pandemic, access to sites has been restricted and remote data monitoring methods have been adopted. Below is a collection of considerations, best practices and resources related to ensuring data accuracy and quality, as well as technology resources that can support the secure viewing of data and documents.
- Considerations and Best Practices
- The ideal solution to remote monitoring is well controlled, direct access to electronic medical records (EMR) by the sponsor that is restricted to only the participants that need to be monitored.
- If EMR access is not available, consider a platform to support sharing of non-electronic documents (Veeva Site Vault, MS Teams, etc).
- Ideally solutions for remote monitoring should seek to minimize site burden. Physically scanning all the source documents is manual and time intensive. Many sites may not have the resources to support.
- Transfer of redacted documents to the sponsor increases risk of privacy breach.
- Ongoing read-only access for the sponsor to the Investigator Site File (ISF) documents, that do not contain participant information, may decrease monitoring burden on the research team.
- Remote data monitoring may require additional IT support and, in some cases, incur extra expense if software licenses have per user fees.
- SOPs may need to be amended to allow remote monitoring .
- Strategies adopted should be in compliance with ALCOA+ principles, specifically the “enduring” and “availability” components.
- Determine institutional policies for allowing remote monitoring and communicate system requirements to sponsors to support the selection of acceptable platforms.
- Essential elements of the privacy assessment to consider
- Canadian housed database may be an important consideration
- Validation of systems (21CFR and GCP compliant) is necessary. Checklists have been developed to support this assessment.
- Solutions must have a robust record retention policy.
- If the site does not have an EMR with remote access, SDV may be completed through video conferencing. Some important instructions include:
- Paper documents must be scanned and shared through a secure program (e.g., Sharepoint/MS Teams).
- No recording or screen shots is allowed.
- The research staff member and the sponsor must both be in a private location when video conferencing, screen sharing or reviewing confidential documents.
- If only de-identified redacted copies of the source are allowed to be provided, a 2nd member of the study team may need to verify copies. This approach may require in-person monitoring by the sponsor (at some time) to be repeated to verify full source documents. The EMA guidance released 2020Apr28 suggests, “the monitor should verify at the earliest opportunity that the provided pseudonymised (coded) data are indeed data related to the trial participant with the provided code”. In some cases, further monitoring may not be required based on this EMA guidance.
- The study team must log each transfer.
- Patient informed consent documents should address the obligations and manner of access for patients’ medical records. Re-consent/re-notification of the patient should not be required if this information is already included in the ICF.
- The clinical trial agreement should cover access and privacy obligations of the sponsor. Have the sponsor CRA sign a confidentiality agreement with any sites offering remote access and complete all essential privacy or platform training prior to the monitoring visit.
- Create an instructional sheet for CRAs to clearly instruct on proper procedures and access to data.
- Ensure the sponsor CRA has access to the EMR and other platforms prior to the visit.
- Platforms that enable compliant document or data sharing, or access to EMR
- Citrix Meditech
- Resources from stakeholder institutions including sample guidance and template documents.
- UHN guidance documents on remote monitoring processes:
- Lawson Health Research Institute guidance documents on remote monitoring processes
- Webinar – Research Ready Mentor spotlight -Remote Monitoring
- Transcelerate Biopharma toolkit and recommendations
- Other toolkits
- Federal agency guidance documents