Acronyms
GCP
What is Good Clinical Practice?
The individual ultimately responsible for the conduct of a clinical trial.
Who is the Principal Investigator (PI)?
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?
A respected veteran with nearly 28 years in the clinical research services industry.
Who is the John Potthoff, Elligo CEO?
Percentage of physicians and patients that do not participate in research.
What is 97%?
PHI
What is Protected Health Information?
The body who oversees or pays for a clinical trial, collects and analyzes the data.
Who is the sponsor?
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?
A network of diverse patients through HIPAA-compliant identified healthcare data.
What is ResearchConnect?
Percentage of trials that miss timelines.
What is 85%?
CAPA
What is corrective and preventive action?
The group that has been formally designated to review and monitor research involving human subjects.
Who is the Institutional Review Board (IRB)?
This provides public assurance that the rights, safety and well-being of human subjects involved in research are protected.
What is GCP compliance?
Has the largest known patient access network.
Up to several hundred people participate, in a study that could last between several months and years with the purpose of studying efficacy and side effects of a drug.
What is a phase 2 clinical trial?
DOA
What is Delegation of Authority?
The person who monitors the running of clinical trials.
Who is the Clinical Research Associate (CRA)?
Serious, unexpected, and related to the study and occurring on a trial that is open at a site subject to review.
What is a Serious adverse event?
State-of-the-art technology platform, provides flexible and agile multi-therapeutic and geographic reach, enabling access to a spectrum of physicians and patients.
What is IntElligo?
11612 Bee Cave Road.
What is the Elligo HQ street address?
ALCOA
What is Attributable, Legible, Contemporaneous, Original and Accurate?
Without these people, clinical research is not possible.
Who are the participants?
This report describes respect, beneficence and justice as key components of clinical research on humans subjects.
What is the Belmont Report?
A digital study buddy like “Alexa” or “Siri” for participants in clinical studies to engage, educate, and retain.
What is ROOT?
The year that Elligo was founded.
What is 2016?