What is the Committee for the Protection of Human Subjects?
100
CTO@hitchcock.org
What is the CTO's e-mail address?
100
The buck stops here
Who is the principal investigator?
100
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
The phase of clinical research involves a small number of subjects and is the first time a drug is used in humans.
What is a Phase One Clinical Trial?
200
a process in which researcher (or appropriately trained designee) discloses all relevant information about a study, a potential subject has opportunity to ask questions, and researcher answers questions.
What is the informed consent process?
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
This report describes respect, beneficence and justice as key components of clinical research on humans subjects.
What is the Belmont Report?
300
High enrolling site
What is a reason for an FDA audit?
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
Graphic display of schedule of activities/visits in a research protocol.
What is the schema of events?
400
This process must occur before any study related activities occur with a potential participant (unless waived or altered by the IRB).
What is the informed consent discussion and signing of the informed consent document?
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
An original record of an event
What is source documentation?
500
This provides public assurance that the rights, safety and well-being of human subjects involved in research are protected.
What is GCP compliance?
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.