ICON Systems
ICON's Clinical Trial Management System (CTMS)
What is ICOTrial?
"CTA" stands for...
What is a Clinical Trial Assistant?
"HIPPA" stands for...
What is Health Insurance Portability and Accountability Act?
"AE" stands for...
What is Adverse Event?
A person or organization contracted by the Sponsor to perform one or more of their trial-related duties and functions.
What is a CRO?
Copies of all documentation relating to a clinical trial are uploaded in this, and occasionally sponsors will provide their own system.
What is Trial Master File?
The leader of an investigational team, usually a doctor at the site.
What is a Principal Investigator?
These are the US regulations that directly apply to bio-pharmaceutical development.
What is the Code of Federal Regulations?
"DSMB" stands for...
What is Data and Safety Monitoring Board?
ICON's CEO
Who is "Steve Cutler"?
Cloud storage used for business content sharing and collaboration within ICON and with our clients and approved vendors
What is BOX@ICON?
This person holds overall responsibility for the continued process improvement of Study Start-Up tasks.
What is a Site Activation Manager?
The US Federal agency charged with promoting and protecting public health by helping safe and effective products reach the market.
What is the Food and Drug Administration?
"ICH/GCP" stands for...
What is International Conference of Harmonization/Good Clinical Practice?
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial
What is Informed Consent?
ICON's system for copies of all documentation relating to a clinical trial
What is ICOMaster?
This person acts as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study setup, monitoring and study close-out for assessment of quality compliance processes for monitoring activities.
What is a Clinical Quality Compliance Lead?
An independent body constituted of medical, scientific and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial
What is Institutional Review Board?
"eCRF" stands for...
What is Electronic Case Report Form?
The number of ICON paid US Holidays
What is 10?
An online cloud-based electronic signing solution used by ICON that automates and controls the entire signing process eliminating the need for manual signature and 21 CFR Part 11 compliant
What is My Signature Book (MSB)?
"GLEXCOM" stands for...
What is Global Executive Committee Member?
An agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation
What is 1572?
"ODQA" stands for...
What is Operational Data Quality Application ?
A set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics
What is the "Deceleration of Helsinki" ?