In order to ensure our investigators conduct safe and effective research, CTSI-CN provides regulatory support services that help break down institutional barriers, reduce investigator burden, and facilitate collaborations. Explore our trainings, services, and tools below, and contact CTSINavigator@childrensnational.org for support.
Looking for more resources and education on issues of regulatory importance? Visit the Virtual Organizer!
Regulatory Services and Tools
Protocol Builder is a secure, cloud-based application that helps simplify the process of writing investigator-initiated protocols. 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 IRB review.
Key Features Include:
- 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)
Email CTSINavigator@childrensnational.org for more information on ProtocolBuilder.
- For an overview of the functions and implementation of Single IRB, take a look around the NCATS-funded SmartIRB site.
- Children's National Research Institute has created a guidance document for Single IRB that can be accessed here (CNH login required).