Select Page

NTRAP Investigator Toolkit

Aim 3 of the NTRAP sought to identify regulatory barriers to conducting trauma research and develop recommendations for best practices. Our toolkit for investigators includes a comprehensive list of current, relevant regulations; definitions of the research challenges inherent in those regulations; a list of common acronyms found throughout the materials; and resulting CNTR publications.

ACRONYM SHEET
The acronyms included in this list were found while conducting the scoping review and may be helpful for research staff to understand the shortened forms of words or phrases commonly associated with regulatory challenges in conducting human subjects research.

 

 

 

 

REGULATIONS
A list of regulations was compiled from articles included in the Aim 3 scoping review. Studies included were published from January 1, 2007 through November 4, 2020. Selecting 2007 as the beginning of the published date range aligned with the year that Congress passed the Food and Drug Administration Amendments Act of 2007, requiring more clinical trials registration, sharing additional trial information, and the submission of summary results, including adverse events.

 

 

REGULATORY CHALLENGES – DEFINITIONS

 

 

 

 

PUBLICATIONS

Regulatory challenges in conducting human subjects research in emergency settings: The National Trauma Research Action Plan (NTRAP) scoping review. Villarreal  CL, et  al. Trauma Surg Acute Care Open. 2023;8:e001044

 

 

Request NTRAP Data for
secondary analyses or inclusion
in a new project

COMPLETE FORM