The Challenge
Biomedical Research Alliance of New York (BRANY) sought a new online subscription platform that would simplify the complex process of writing research study protocols. Medical professionals needed to be able to answer a series of questions to help choose from a set of templates previously approved by their medical institution.
Writers also needed to upload tables and charts, import references and footnotes from third-party research tools. Most importantly every protocol needed to be vetted with their peers allowing for commenting and editing with all changes tracked similar to MS Word.
Finally the protocol needed to be easily exported to PDF or Word for submission to the Institutional Review Board (IRB).
Sourcetop’s Solution
We began by creating the platform in Drupal, a powerful content management system (CMS) ideal for complex publishing requirements. We also developed a custom iOS app for users on iPads. From the desktop site or the iOS application, users can seamlessly write, manage and invite stakeholders to edit and review medical protocols.
The system enables users to upload images, Excel charts and PDF documents for insertion, and includes tools for adding dynamic references, footnotes, definitions and abbreviation tables. Users can track revisions, make comments, import references into a master library and output a formatted Word doc or PDF with an automated Table of Contents and revision history for easy IRB submission.
With pre-approved templates, sample text, online help and topic-by-topic guidance users can quickly flush out their study knowing their paper will pass the rigorous review process.
The Results
Thousands of users from hospitals and medical universities across the US now use Protocol Builder to manage their protocol writing process.
Institutions can create custom landing pages with IP based restricted access for self-registration of users and with the addition of single sign on (SSO) Protocol Builder has been seamlessly woven into IT infrastructures ensuring long-term partnerships.
Since launch new templates and custom templates per Institution have been added knowing that all documents created in Protocol Builder meet IRB and regulatory standards, supporting BRANY's goal of providing hospitals and medical schools IRB and clinical research support service.
An independant study found an administrative cost decrease of 85% compared to MS Word.Ascension Healthcare
An independent study by Ascension Healthcare found that when comparing two protocols of similar complexity Protocol Builder users required less assistance from administrative support staff than Microsoft Word users, resulting in an administrative cost decrease of 85%. Specifically, Protocol Builder reduced the time that administrative support personnel had to devote to formatting, organizing, and citation review of an investigator’s submitted protocol.