During this pandemic, a key aspect of remote monitoring that seems to be a source of struggle for the industry is source document review and verification. This is an extremely important aspect of this work, but also an extremely risky one, as sensitive PHI is shared across virtual organizational walls. Fortunately, there is a very simple solution if the right eRegulatory solution is used.
Here are the three primary requirements when looking for a remote source document review solution:
1) HIPAA Compliance – This should be top of mind. Confirm with the eRegulatory solution provider the platform complies with the provisions of the HIPAA Security Rule and can securely store patient information. The system should only require a single electronic copy of a document — even when that document is applicable to multiple studies — to eliminate the chaos and risk of endless copies. The system should also include a standard way of naming, filing, and tracking all document activity for easy access and auditability.
2) Easy and controlled access: The platform should provide customizable and granular control over exactly who has access to these documents, including external monitors. Monitor access should be read-only so they are unable to receive any copies, making redaction unnecessary. They [monitors] should be able to view all PHI just as if they were onsite viewing the original source document, including all patient identifiers.
3) No required redaction! The burden of redaction falls entirely on the site staff, which can take up precious time and leave room for error. The right eRegulatory system will have access controls in place to allow those with specific permissions to view all relevant information on these documents including PHI. With those controls and direct access within the system, redaction is completely unnecessary. This approach can actually reduce the risk of PHI getting into the wrong hands and simplifies the work overall.
The right eRegulatory solution will empower the sites to have more efficient and effective regulatory processes while enabling monitors and sponsors to have the oversight they need, all while remaining compliant. This is not about simply digitizing manual, tedious processes – it is about transforming and simplifying the management and review of regulatory work, even extending to include critically important source documents.
Complion has already implemented a number of source document monitoring solutions during the pandemic and is here to help identify the right solution for your sites. Be sure to read, “An Alternative Source Document Solution for COVID-19 and the Future.”