TheraScan offers an efficient method to store, organize and track essential documents that sites must maintain for clinical trials.
Patient-base documents like informed consent releases, inclusion/exclusion criteria and medication lists are easily uploaded to the repository. Sites can easily view the completeness of the electronic “binders” (eBinder) at a glance to see which document are missing. Similarly, monitors can quickly scan a site patient documents from a remote location.
Staff-based documents are similarly managed with TheraScan. Signature records, FDA 1572s, licenses and curricula vitae are easily loaded and viewed by site staff and monitors.
Site-based documents are the third component of the TheraScan eBinder module. Sponsors and sites can easily customize the document types to track in the system. These include those typical documents like IRB approvals, subject logs and the site agreements. Additional document types can be specified to support sites that have labs, manufacturer the investigational product or need to track inventory.
Other useful features support expiry tracking, versioning of documents and site-specific document versions that supersede study-wide masters. Document types are fully customizable by the client.