Unblinded Solution

Background

An unblinded document is a document that that discloses information about the intervention assignment in a clinical trial. In a double-blind randomized trial, it is required that neither the patient nor the clinician is aware if the patient is recieving treatment or placebo. If that blind is broken, the patient’s trial data is invalidated and cannot be used to prove efficacy. Documents or data that disclose information about this intervention assignment are known as Unblinded information, and must be protected from clinicians and clinical staff. The key challenge inherent in the storage and management of electronic Trial Master File (eTMF) documents for studies that contain blinded documents is maintaining the integrity of the blinding while ensuring proper document accessibility and regulatory compliance. This involves several critical aspects:

  • Segregation of Data: Blinded documents need to be stored separately, ideally in a separate repository, from unblinded documents to prevent accidental unblinding. This requires a robust system for categorizing and segregating documents.
  • Access Control: Strict access controls must be implemented to ensure that only authorized personnel can view blinded documents. This includes setting permissions and audit trails to monitor who accesses what information and when.
  • Regulatory Compliance: Ensuring compliance with regulatory requirements such as Good Clinical Practice (GCP), GDPR, and other relevant guidelines is essential. This includes maintaining secure, traceable, and auditable records.
  • Document Integrity: Maintaining the integrity and confidentiality of blinded documents while enabling necessary updates and collaboration can be challenging, especially in a digital environment where data breaches and unauthorized access are risks.
What is an Unblinded Solution?

Trial Interactive’s Unblinded eTMF solution provides a validated, dedicated repository to electronically store these documents for a trial where the blind has not yet been lifted that keeps these documents separate from other trial documents. Separating unblinded trial documents from blinded trial documents allows for the ability to align document work streams with regulatory compliance practices. It also enables an unblinded study team to follow critical processes for metadata and document approval without revealing restricted trial information.

What does the solution do?
  • Leverages configuration to support TMF completeness and contemporaneousness
  • Allows for segregation of blinded and unblinded documents when used in conjunction with a blinded eTMF solution.
  • Eliminates the need for complex folder- and document-level security. These complex configurations can introduce blinding risk.
  • Provides a quick and easy ability to combine both blinded and unblinded documents into a single space once the blind has been lifted.
  • Contains a streamlined index developed from the CDISC Reference Model highlighting the documents that typically contain unblinded content.
  • Eliminate complex security assignments that introduces risk of unblinding data and documents.
  • Meet regulatory guidance (insert guidance here) that requires unblinded documents to be stored in an independent, seperate repository.
  • Facilitate the ability of a user to identify restricted document content prior to filing.
System/Technical Requirements
  • The Unblinded eTMF solution is assumed to have a limited number of users with approved access to unblinded documents.
  • This solution has a streamlined index targeting unblinded document types.
  • This solution has the ability to set Required Documents to provide accurate TMF completeness.
  • This solution has Event Manager with Trigger Criteria enabled to meticulously track study documentation.
  • This solution has the ability to perform Quality Review for oversight.
High level technical capabilities:
  • Users can view, modify metadata on documents within a workflow
  • Users can Copy/move documents between rooms/Sites
  • Users can perform Quality Review
  • Users can add Event Triggers/Event Manager to rooms to manage placeholders
  • Users can run reports on Inventory, KPIs, User Access
  • Ability to access Audit Trail
  • Ability to add or remove user access
Solutions available for interoperability:
  • Global Learn
  • CTMS
  • TI Connector
  • TransPort Translations