BRANY's Protocol Builder and Informed Consent Builder Demonstration from June 14th, 2024.

 

 

Please see below for the answers to the questions from the UVA research community that we ran out of time to cover at the presentation with minor edits for clarity and similar questions combined (answers are in blue and italics for distinction):

  • To confirm, can you import your own template that is already approved by the IRB and the system is able to adapt the naming conventions to your sections?  Can you revise section titles of a pre-existing template? All Protocol Builder templates can be modified. This would currently be accomplished by UVA Protocol Builder administrators providing the desired templates and/or changes to existing templates to the Protocol Builder team for implementation. It is soon expected that Protocol Builder client administrators will have the ability to do this without interaction with the Protocol Builder team.

  • What I'm seeing is a way to write a new protocol and ICF for an Investigator Initiated Trial. How will pharma (industry sponsored) studies be handled (for protocol and consent)? Protocols (and subsequent protocol amendments) are provided by the sponsors for industry-sponsored studies. Protocol Builder is a protocol development and writing tool.

  • Will this system be updated with any NIH changes in requirements? Any updates and changes to Protocol Builder templates can be requested by UVA Protocol Builder administrators and incorporated by the Protocol Builder team. 

  • Will the researcher's CITI training be visible? There is currently there is no interface to link protocols with CITI profiles. This is usually done via the organization’s electronic IRB review and submission system. We can certainly explore customizations to link CITI training accounts to Protocol Builder. 

  • Could these systems be used for reliance agreements? I’m not sure exactly how it is envisioned for Protocol Builder to be used for reliance agreements, but the system is very flexible, and this can certainly be explored. We would just need some more information and understanding exactly what is trying to be achieved.

  • Does the system have spelling and grammar check? Spelling and grammar check is achieved by turning this function on in the browser the user is accessing Protocol Builder through.

  • How do you hyperlink within the document? There is hyperlink icon within each section’s text editor where you are able to highlight text and hyperlink. See screenshot and highlighted icon below. 

 

  • How do you add captions to tables and figures?  Captions are built in to both tables and figure functionality.  In both cases, the captions are captured and showed as part of the table/figure but also in the List of Tables or List of Figures.

  • Can you resolve comments within the system, similar to how Word functions for comments? Yes, please see screenshot below. 

 

 

  • Is it easy to change the reference list format to another format?  Currently, the reference list format is in MLA format. Other formats are being considered for Protocol Builder version 2.0.

  • Can you import easily from EndNote? Yes, you can import from any online library that exports files as .ris or .nbib files. These files are then uploaded to Protocol Builder to build your library.