A central Clinical Trial Management System to hold information on all clinical trials at DH.
What is Velos?
100
Publication rights
What is one drop dead issue in negotiating a clinical trial agreement?
200
CRF
What is Case Report Form?
200
Systematic review of all research-related documents to determine the Medicare qualifying status of the study itself and the Medicare billing status of the items and services
What is a Medicare Coverage Analysis?
200
Linda Park
Who is the person to contact when you need lab services for a clinical trial?
300
IND
What is Investigational New Drug?
300
Serious, Unexpected, Related to the study and Occurring on a trial that is open at a site subject to CPHS review.
What is a Serious Adverse Event as defined by the CPHS?
300
A device that usually represents a new application for existing technology for which underlying questions of safety and effectiveness of that device type have been resolved.
What is a Category B Device?
400
HIPAA
What is the Health Insurance Portability and Accountability Act?
400
Oversees federally-sponsored clinical trials?
What is the Office of Sponsored Projects at Dartmouth College?
400
You must contact this department when you have a new protocol that involves a study drug.
What is the Investigational Pharmacy?
500
DSMB
What is the Data and Safety Monitoring Board?
500
You must have IRB approval before you do this.
What is recruit subjects for a clinical trial?
500
This must occur as soon as a study participant is enrolled in a clinical trial.