The
Core Laboratory for Clinical Studies (CLCS)
The Core Laboratory for Clinical Studies (CLCS), based at Washington University School of Medicine is a CLIA-certified clinical laboratory specializing in the support of clinical research studies of all sizes and complexities. Founded in 1972 to provide laboratory services for clinical studies, the CLCS has more than 30 years experience in providing clinical trial support to government, industry and university sponsors. In addition to providing pharmaceutical clinical trial support, CLCS works closely with manufacturers of diagnostics devices to provide services to facilitate assay/instrument development.
The Core lab can also serve as a resource for diagnostic assay development and new method evaluation.
The CLCS specializes in lipid and lipoprotein measurements and a wide variety of esoteric analyses.
Safety
and efficacy testing, including general chemistry, endocrine, bone metabolism,
hematology, coagulation, tumor marker, cardiac risk and urinalysis are available
through the CLCS. If your study has a need that is not listed on the link
below, please contact the CLCS to discuss specialized testing. A
listing of laboratory services and fees for tests conducted at CLCS is attached
here PDF . For
tests not run at CLCS, specimens will be processed by Quest Lab. The
following list provides information on outside tests and cost PDF.
The CLCS can be contacted at 314-362-3522 or
CLCS@im.wustl.edu
.
Biostatistical Resources
Expert biostatistical input is an essential element of proper experimental design and analysis. Research is undergoing increasing scrutiny with regard to biostatistics in study sections (which increasingly are being populated with biostatisticians) and manuscript review by journals. The best strategy is to obtain biostatistical advice early in a project (i.e., before the first subject is enrolled); this can often improve the likelihood of the study meeting its objectives. Presenting a data file to a statistician from a completed, but inadequately designed experiment, and asking for an analysis, will not be enthusiastically welcomed. Nonetheless, biotatistical input even at this point can help. The DoCTR has identified two potential sources of statistical advice and collaboration to assist investigators in their research.
Washington
University Department of Medicine,
Biostatistics Consulting Center
William
D. Shannon, PhD, Director
The Department of Medicine, Division of General Medical Sciences has a Biostatistics
Consulting Center (BCC) offering comprehensive statistical consultation and
computational services to faculty, staff, and students throughout the University.
BCC personnel (PhD faculty and MS statisticians) are available for discussion
at all stages of research, including preparation of grants and contracts,
assistance in analyzing and presenting research data, and statistical review
of manuscripts in the publication process. BCC's primary interest is in assuring
appropriate use of statistical methodology. BCC also offers a complete range
of services, from database development, implementation, and maintenance to
production of publication quality graphic and tabular material to support
the presentation and publication of research results.
Obtaining biostatistical advice early on in a project (i.e., before the first
subject is enrolled) can often improve the chances of the study meeting its
objectives. Investigators should set up an initial consultation (free of charge)
with a BCC faculty member, to review the research needs and study design issues,
to estimate workload, and to plan a realistic timetable. The investigator
should provide a brief summary of the objectives and study design, before
the meeting.
Compensation can be based on 1) hourly rates $200/hr or 2) inclusion of BCC
faculty as co-investigators on grants and other long-term projects with an
appropriate funding-level for BCC included in the budget.
For further information, please visit: The
Research Design and Biostatistics Group (RDBG)
Educational Opportunities
Clinical
Research Coordinator Workshop Series (CRSTNET)
How to Coordinate Clinical
Trials: INVESTIGATOR BASICS
Barnett
International Educational Seminars: Clinical Research
DoCTR Educational Grant Opportunity
The DoCTR is offering, to Principal Investigators and Key Research
Personnel, in the Deapartment of Anesthesiology at Washiington University,
grants to pay the cost of obtaining GCP certification through the on-line
GCP program. Awards will be made upon successful completion of all course
modules and receipt of certification.
"Good Clinical Practice in Research" (GCP) is an international
ethical and scientific quality standard for conducting clinical research.
GCP standards are recognized by the Office for Human Research Protections
(OHRP) and are included in the U.S. FDA guidance document for clinical trials.
Knowledge of GCP will improve your abilities to plan, conduct and monitor
your clinical research. Many pharmaceutical sponsors and institutions require
investigators to be GCP certified.
GCP training is different from the NIH-required education
on the protection of human research participants. Instead, GCP training emphasizes
practical roles and responsibilities of the research team.
The Department of Anesthesiology Division of Clinical and
Translational Research (DoCTR) strongly encourages
Principal Investigators and their staff to know and understand GCP. A GCP-certified
DoCTR will put us in an institutional leadership position at WUSTL.
GCP certification can be obtained by taking a commercial
GCP course (expensive, time-consuming, requires air travel), or by Web-based
GCP training (more convenient). The Web-based Clinical Research Training for
Investigational Site Personnel (CRISP) course (www.clinfosource.com) is intended
to provide investigators and their staff with a better understanding of the
regulations regarding human subjects research, and a their own responsibilities
in planning and conducting clinical trials.
The Web-based training carries both Continuing Medical
Education (CME) and Continuing Nursing Education (CNE) accreditation. It is
also continually available to users as a free reference. Any additional cost
associated with obtaining CME or CNE accreditation is the responsibility of
the individual.
To apply for the Web-based GCP training program, please
contact Patty Suntrup.
Office: 747-1709, email: suntrupp@wustl.edu.
can be found on the Department of Anesthesiology intranet