Regulatory Support

vaccine bottles

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

ClinicalTrials.gov is a web-based resource that provides patients and families, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical trials on a wide range of diseases and conditions. CTSI-CN offers guided support for registering trials on ClinicalTrials.gov. For more information, email CTSINavigator@childrensnational.org.
The Responsible Conduct of Research (RCR) Series at Children’s National hosts monthly presentations and discussions with major local and national voices on responsible conduct of research. Featuring a balanced mix of notable guest speakers and intimate discussions, the RCR Series engages the entire research team in discussions of ethics, current regulatory issues, and decision-making in the complicated world of human subjects research.

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 investigators joining or initiating multi-site trials, looking for guidance on utilizing Single IRB can be difficult. To learn more about the function and implementation of Single IRB, take a look around the NCATS-funded SmartIRB site.