Validation Study of the Transfusion Risk and Clinical Knowledge (TRACK) Tool in Cardiac Surgery Patients: A Retrospective Analysis.

Objective: The Transfusion Risk and Clinical Knowledge (TRACK) scoring system has been developed for predicting perioperative blood transfusions. However, the TRACK score needs to be validated externally in the US population. The primary objective of this study is to validate TRACK at the authors' institution.

A Retrospective Analysis of Clinical Research Misconduct Using FDA-Issued Warning Letters and Clinical Investigator Inspection List From 2010 to 2014.

Background: The US Food and Drug Administration (FDA) conducts inspections of clinical investigation sites as a component of clinical trial regulation. The FDA describes the results of these inspections in the Clinical Investigator Inspection List (CLIIL). More serious violations are followed up in FDA warning letters issued to investigators.