Research and Clinical Trials
The MWH Research Department was established in 2004 and supports our mission
to improve the health of the people in the communities we serve by advancing
research innovation and furthering the knowledge of healthcare professionals.
We put this commitment into practice every day by conducting clinical
trials. Plus, it gives our patients access to new treatments and therapies.
As a department within Mary Washington Hospital, our experienced research
staff coordinates and facilitates all operational aspects of clinical
trial management including regulatory compliance, IRB submissions, and
approval of research proposals.
What is clinical research?
Clinical research plays a critical role in the prevention and cure of various
health disorders and involves the study of the clinical effectiveness
of materials and methods. Each trial explores the possibility of prevention
and cure for numerous medical disorders.
Clinical research studies examine the essential results for proper healthcare
management, by monitoring practices concerning safety, effective medical
practices, diagnostic techniques, devices, new medications, diagnostic
tools and regiments.
1201-B Sam Perry Blvd., Suite 265
Fredericksburg, VA 22401
Research vocabulary and definitions:
International Conference on Harmonisation (ICH)
International Conference on Harmonisation (ICH) is an international organization of both regulatory agencies and
pharmaceutical manufacturing associates that attempts to rationalize and
harmonize regulations. It has grown in response to rising research costs,
increased length of time in bringing needed products to the market place
and the inconsistencies in technical requirements among countries. The
ICH structure is composed of many members from all over the world. ICH
focuses on four main topic areas: Quality, Efficacy, Safety, and Multidisciplinary.
Institutional Review Board (IRB)
Institutional Review Board (IRB) is an independent body constituted of medical, scientific, and non-scientific
members, whose responsibility is to ensure the protections of the rights,
safety and well-being of human subjects involved in the trial by, among
other things, reviewing, approving, and providing continuing review of
trial protocol and amendments and of the methods and material to be used
in obtaining and documenting informed consent of the trial subjects.
Principal Investigator (PI)
Principal Investigator (PI) The primary person responsible for the conduct of the clinical trial
at a trial site. If a trial is conducted by a team of individuals at the
trial site, the Investigator is the responsible leader of the team and
maybe called the principal investigator.
Sub-Investigator (SI) any individual member of the clinical trial team designated and supervised
by the investigator at a trial site to perform critical trial-related
procedures and/or to make important trial-related decisions (e.g. associates,
residents, research fellows).
Clinical Research Coordinator (CRC)
Clinical Research Coordinator (CRC) An individual who assists the investigator in conducting the trial and
is usually the main person who coordinates the daily tasks associated
with the trial.
Good Clinical Practice (GCP)
Good Clinical Practice
(GCP) Is a standard for the design, conduct, performance, monitoring, auditing,
recording, analyses, and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate, and the
rights, integrity, and confidentiality of trial subjects are protected.