• The TheraScan servers are hosted in an SSAE 16 Type II certified data facility.
     
  • The TheraScan servers are in a secure/locked cabinet behind a dedicated Cisco ASA firewall.
     
  • The systems run in a virtualized environment with the certification and repository functions on separate physical servers. Development and test environments are also on separate physical servers.
     
  • Records with PHI have field-level encryption via SSL with a randomized initialization vector stored on the host server and the randomized key on the remote certification server.
     
  • PHI, which can be included as part of the certified source document copy, is always encrypted when “at rest” in the system.
     
  • The decryption process is individually logged; recording the specific decrypted record id, the authorized requester as well as a date-time stamp. This log is viewable by the trial investigator.
     
  • Decryption can only be accomplished by the user who loaded the information, other site staff or the investigator-authorized monitor. Exceptions include study-specific documents without PHI such as the protocol or blank CRFs and documents loaded as part of a severe adverse event.
     
  • No direct database access is allowed to users. Access is via the secure web site.
     
  • All communication over the public internet is via the HTTPS, SSL or SSH protocols.
     
  • Access to the certification server is only via the RESTful web interface from known locations.
     
  • Daily backups are encrypted with a public key and then securely uploaded to a remote repository.
     
  • Incremental (record-level backups) are encrypted with a public key and uploaded to a remote database. Redundant records are regularly purged from the remote database.
     
  • The password-protected private keys needed for decryption are kept on an FIPS 140-2-validated encrypted flash drive in a secure location.
     
  • Monitors are required to use two-factor authentication. TheraScan uses a FIPS 140-2-validated system from Duo Security that utilizes mobile phones as the token.
     
  • Source document certification is made using SSL with a user-specific, password-protected, private key and SHA-256 signature algorithm. This is countersigned by the certification server with a server-specific private key and SHA-256 signature algorithm.
     
  • The user-specific public key, the certification-server public key and the SHA-256 hash “fingerprint” are stored on the certification server for use in verifying the authenticity of the certified source document copy.
     
  • The TheraScan system uses Oracle databases with an option for distributed repositories to utilize PostgreSQL.
     
  • Access-control to the system is processed through the database. A user may only access one study at a time.
     
  • TheraScan utilizes an “insert-only” model such that data records are neither updated nor deleted once in the table.
     
  • Access to specific information in the repository is granted via dynamic, user-specific, views that grant access based on the logged in user. These views do not contain PHI.
     
  • The primary table in the repository contains the encrypted certified object in a BLOB field and the related metadata in an XMLType field. The metadata does not contain PHI.
     
  • Authorization is managed via a two-factor process requiring both email and SMS tokens in order to activate a new user. Passwords require eight characters and must include upper and lowercase letters, numbers and special characters.
     
  • TheraScan uses HTML5 websockets for communication with the TWAIN device (scanner).
     
  • A study’s Informed Consent should include a section to recognize the loading of source documents to the TheraScan system for review by study monitors.

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