Please Note: Per Children's National OPHS/IRB, if you are writing an IND/IDE protocol that is subject to FDA regulations you please must refer to the official protocol template ("CNMC IND Protocol Template_5.8.17.docx") located on the "Forms and Templates" section of the IRBear website.
As the Nation’s Children’s Hospital and as a leading pediatric research institution, the most important mission at Children’s National is to advance the understanding, prevention, and treatment of diseases that afflict children. As part of this pursuit, the Clinical and Translational Science Institute at Children’s National (CTSI-CN) has positioned itself as an effective catalyst for child-health clinical and translational research around four major themes: 1) improving child health, particularly for under-served populations; 2) developing novel treatment strategies for rare genetic diseases; 3) designing new devices for pediatric care; and 4) characterizing childhood precursors of disease along the lifespan. The CTSI-CN continues to advance our vision and mission through innovative approaches and enhanced capabilities. Via the implementation of focused research processes, and by introducing novel, supportive applications/tools we are well on our way to serving as a catalyst for quality research.
In an effort to accelerate advancement in this undertaking, the CTSI-CN is pleased to announce our collaboration with BRANY (Biomedical Research Alliance of New York) to introduce Protocol Builder, 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.
- 17 various Protocol Types – Observation and Interventional; NIH IND/IDE
- 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
Please visit the links below to learn more about this fascinating new tool:
- CTSI-CN Protocol Builder Introduction
- Protocol Builder Feasibility Study Presentation
- Protocol Builder - Starter Guide