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Florence eBinders: Blinded Study Management UW User Guide

A blinded study is a type of study in which the participants (single-blinded) or the participants and the study team (double-blinded) do not know which drug or treatment is being given. Occasionally, there are studies where only some members of the study team are blinded and this user guide addresses the use of Florence eBindersTM for these studies.

Who is responsible for maintaining the blind within eBinders?

The burden of maintaining the blind within eBinders falls upon the user(s). Due to the complexity of managing the blind, it cannot be managed by the Application Support team via changes to the system (e.g., manual role mapping, folder structure alterations). If the study team members who must remain blinded are given mapped roles within OnCore, it is their responsibility to avoid accessing folders that may contain documentation that would break the blind. Refer to Florence eBinders: Roles and Permissions for more information.

What can the study team do within eBinders to support the blind?

The following actions are recommended:

  • If the documentation that would break the blind is limited to the top-level Subjects folder, update the folder name to contain a warning. For example, Subjects_If blinded, do not enter.
  • When obtaining signatures from blinded study team members, such as on a Delegation of Authority (DOA) electronic log (elog), send a signature request to ensure they receive a direct link to the log/document. You could also remind them of the blind and tell them to refrain from engaging with documentation other than that for which a signature is being requested.
  • Have blinded study team members use deeplinks to access study documents (e.g., protocol, consent documents) whenever possible to avoid erroneously navigating to documentation that would break the blind. Refer to Florence eBinders: Deeplinks in OnCore UW User Guide for more information.
  • Use the Tasks functionality to provide a direct link to a document that requires a non-signature action.
  • Document who is and is not blinded in an easily accessible location for quick reference, such as the DOA elog.
    • To do this, update the elog legend to include a letter assignment for Blinded to Study Treatment and then be sure to assign that letter to applicable study team members on the elog.
  • Identify and document which study team member(s), preferably someone who is NOT blinded, to routinely check the audit trail for the folder(s) that may contain documentation that would break the blind to ensure blinded study team members have NOT accessed it. The checks are to occur more frequently for the first 1-3 months (e.g., weekly, bi-weekly) of the study, and then can occur less frequently (e.g., monthly, quarterly). 

What can the study team do beyond eBinders to support the blind?

  • Ensure all study team members, including those who are not blinded, are aware of the audit trail functionality within the system.
  • When appropriate, refer to visit related documentation within the participants electronic medical records instead of eBinders.
  • If the blind is broken, immediately report this to the Principal Investigator, sponsor, etc. as appropriate.

KeywordsFlorence, blind   Doc ID136151
OwnerJill K.GroupSMPH Research Informatics
Created2024-03-20 10:34:24Updated2024-04-26 13:10:59
SitesSMPH Research Informatics
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