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Close Out Study

The Clinical and Translational Science Institute at Children's National (CTSI-CN) is proud to support Children's National Health System and The George Washington University research faculty and staff by providing a variety of supportive resources and tools. 

Each CTSI-CN Cores and Modules provides access to and support for the following resources designed to aid with study closeout:

ClinicalTrials.gov

Clinicaltrials.gov is a web-based resource that provides patients, their family members, 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.

The purpose of Clinicaltrials.gov is to share key information with the public about current and past clinical trials. Clinicaltrials.gov captures significant summary information before and during the clinical trial as well as summary results and adverse event information of a completed clinical trial. Federal laws and regulations as well as editors of prominent medical journals require registration of a clinical trial, as described below.

Clinical trials are generally submitted (that is, registered on the website) when they begin. Information on Clinicaltrials.gov is provided by the sponsor or principal investigator (PI), who updates the information throughout the clinical trial. In some cases, results of the clinical trial are submitted after the clinical trial ends. Website commonly referred to as a "registry and results database", this website is a publicly available database of federally and privately supported clinical trials conducted in the United States.

To learn more about ClinicalTrials.gov please visit: ClinicalTrials.gov

Research Poster Templates

Both Children's National and GW offer a number of poster templates, as well as additional guidance and support for research faculty and staff.

To learn more about Research Poster Templates please visit: Research Poster Templates

Research Toolkits

Children's National has designed an Investigator and Study Team toolkit to guide Children's National research teams through various administrative and regulatory policies and procedures related to the submission, review, and approval of clinical trial research. The goal of this toolkit is to assist with navigating the review and approval process as quickly and efficiently as possible.

Additionally, the CTSI-CN has also developed an addendum toolkit that includes additional regulatory resources.

To learn more about Research Toolkits please visit: Research Toolkits

Required Grant Citation Language

The National Institutes of Health (NIH) Public Access Policy ensures that the public has access to published results of NIH funded research. Effective on or after 07/01/2013 for non-competing renewals, NIH will enforce its Public Access Policy which has been in effect since 04/2008. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central (PMC) upon acceptance for publication. Enforcement will take place when the Principal Investigator (PI) prepares his/her annual progress report, the Research Performance Progress Report (RPPR) or PHS 2590. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PMC no later than 12 months after publication, or NIH will delay processing of the grant's annual funding until the PI has demonstrated compliance.

To learn more about Required Grant Citation Language please visit: Required Grant Citation Language

Request Support (SPARC Request)

SPARC Request (Services, Pricing, & Application for Research Centers) is a web-based research transaction management system that was created at the Medical University of South Carolina (MUSC). SPARC Request provides a central portal for researchers and their study teams to browse for research services and resources as well as submit service and pricing requests.

SPARC Request features include:

  • Order services from various CTSI-CN modules/cores

  • Create budgets for studies/projects

  • Manage active studies/projects within the user Dashboard

  • Track research activity for services provided by CTSI-CN Cores

  • Fulfill service requests in real-time

  • Communicate directly with your service providers

  • Generate various reports for study teams

To learn more about SPARC Request please visit: Request Support (SPARC Request)