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Protocol Builder


***Please Note: Per Children's National Hospital OPHS/IRB, if you are writing an IND/IDE protocol that is subject to FDA regulations you must refer to the official Children's National protocol template ("CNMC IND Protocol Template_5.8.17.docx") located within the "Forms and Templates" section of the IRBear website.***


Protocol Builder is a secure, cloud-based application utilized to simplify the process of writing investigator-initiated protocols.

Accessible online via a desktop or tablet, this tool facilitates the development of protocols that meet institutional research regulations (e.g., IRB, Research Administration, etc.), as well as Federal regulatory standards. Via the user-friendly interface, Protocol Builder helps writers navigate the complexities of protocol development and fosters institutional collaboration. Additionally, this tool also serves to facilitate the standardization of protocol format, mitigating the time and effort required for SRC, IRB, etc. review.

Key Features:

  • 19 Protocol Template Types – Observation and Interventional; IND/IDE* ; Repository
  • Collaboration Support – Add study colleagues as writers or reviewers
  • Expert Guidance Icons – Detailed explanation of the requirements for each field
  • Smart Forms with Branching Logic – Predictive and reduces the need for double-entry of text
  • Resource Center – Provides commonly used Research forms and allows addition of supporting documentation
  • Reference Builder – Import references from various reference software solutions (ris and nbib files)

Who can use this resource?

All Children’s National Hospital research faculty and staff can utilize Protocol Builder. This includes investigators, research nurses/coordinators, research assistants, etc.

Access for outside collaborators is reviewed on a case-by-case basis and is provided at the discretion of the CTSI-CN Protocol Builder administrative team.

How much does access to this resource cost?

Protocol Builder is offered at no cost. To see the cost of other CTSI-CN resources, please visit SPARC Request.

How do I access this resource?

Please click HERE to complete the Protocol Builder interest form. Once completed you will be provided instructions to register for access to Protocol Builder.

Who should I contact for more information?

Please visit the CTSI-CN Faculty and Staff Directory and select the "Clinical Research Navigator" service area to find the person responsible for this resource.

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