Overview
The Office
of Clinical Research (OCR) is a centralized resource to facilitate
the development, conduct, quality assurance monitoring and compliance
with regulatory agency requirements of clinical research/trials at
Maine Medical Center (MMC). The office is a “One Stop Shop” designed
to provide support for clinical research studies initiated by MMC investigators,
as well as industrially sponsored clinical trials and cooperative group
studies. Services are provided through strong collaboration with
the Office of Research Compliance, Grants and Contracts, and Financial
Services staff.
At any
given time, there are approximately 250 approved studies actively recruiting
a total of approximately 3,000 subjects in the following departments: Anesthesiology,
Cardiac Services, Critical Care, Emergency Medicine, Family Medicine,
Medicine, Nephrology, Nursing, Obstetrics and Gynecology, Pathology,
Pediatrics, Pharmacy, Psychiatry, Radiology and Surgery.
Our vision
is to centrally provide comprehensive support for sponsored clinical
research which meets the needs of investigators, research coordinators
and sponsors, ensures compliance and furthers the mission and reputation
of MMC. We are also dedicated to facilitating the development
of powerful research relationships within the medical center and with
external organizations. The OCR has a strong leadership and coordination
role throughout the MMC research community.
Our cornerstone
consists of:
- Prompt
response and resolution
- Customized
consultation for study start-up
- Budget
development
- Innovative
initiatives
- Systems
approach to problem-solving
- Quality
improvement
- Networking
throughout the research community
It is suggested
that investigators and research coordinators involve the OCR early on in
the start-up of a new clinical research study. A comprehensive, streamlined
plan will quickly be developed to ensure that the investigator and his/her
research staff access all the research administration and financial services
necessary to get the protocol reviewed and finalized, to develop the IRB
application and the Informed Consent in a timely manner, to process the
contract agreement with the appropriate research administration staff,
and to develop a budget designed to support all the costs related to the
proposed study. Access to research design and statistical support
from the Center for Outcomes Research and Evaluation (CORE) also is included.
