Alphabet Soup
CRF
Case Report Form
CFR for Protection of Human Subjects
Part 50
When outside interests unduly influence professional judgment
Conflict of Interest
Ultimately responsible for all aspects of the study.
Principal Investigator
CSP
Clinical Study Plan
CTMS
Clinical Trial Management System
A statement which gives information about the study, its procedures, benefits, and risks to a prospective subjects so they can make an informed decision about participation.
Consent Form
The process in which persons decide to participate in a research study
Informed Consent Process
Phase of Clinical Trial that evaluates safety
Phase 1
Regulatory and Lab Co-worker
Sara Jane Salstrom
SIAE
Serious Internal Adverse Event
The factors that are considered to allow someone to participate in a clinical trial
Inclusion Criteria
You must have IRB approval before you do this
Recruit Subjects for a Clinical Trial
Serious, Unexpected, and Related or Possibly Related
Unanticipated Problem (UAP)
Policies and Processes live here (source of truth)
Summa@Work
IND
Investigational New Drug
An original record of an event
You must have this before you perform any research-related activities
Consent
Data and Safety Monitoring Board
OCRB
Office of Clinical Research Billing
IB
Investigator Brochure
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
Coverage Analysis
The name of the report outlining these basic principles of the ethical conduct of clinical research.
Belmont Report
Serious Adverse Events
Results in death, Life-Threatening, Results in hospitalization, Results in disruption of the ability to conduct normal life, Results in congenital anomaly, Requires medical or surgical intervention
This office oversees research to ensure it is ethically and scientifically sound, and conducted in compliance with all Federal regulatory requirements
Office of Research Administration