Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation.

The internal jugular vein maintains its regional anatomy and patency after carotid endarterectomy: a prospective study.

Objective: To validate the authors' published surface landmarks for gaining percutaneous access to the internal jugular vein (IJV), and to determine whether these surface landmarks were altered after neck surgery.

Summary Background Data: Carotid puncture and pneumothorax continue to be the most frequent mechanical complications of percutaneous IJV venipuncture, particularly when the anterior or posterior approaches are used. The authors' modified technique of IJV venipuncture was associated with a 0.