CDS Services
The
Center for Drug Studies (CDS) of the School of Pharmacy serves
as a clinical core laboratory for all faculty in the School and
other
clinical investigators at VCU. A full range of clinical services
are available to investigators, including all aspects of study
design,
management, data collection and reporting. The clinical investigator
(PI) can elect to use any or all the services for a given study.
For example, the PI can use the Center just to recruit patients
using the computerized database or to have blood samples drawn
and
processed at specific times by trained phlebotomists and technicians
or can elect to have the entire study managed by the CDS staff.
The costs for the services can be billed on an hourly basis or
as a subcontract. A partial list of services are shown below.
SERVICES AVAILABLE
- Study design
- Preparation of protocol
- Preparation of Source Documents for initial data collection
- Preparation of Case Report Forms (CRFs)
- Budget preparation
- Recruitment of Subjects
- Project management
- Study implementation
- Screening of subjects
- Day/night supervision of subjects
- Nursing Services
- Phlebotomy
- Collection of samples (urine, saliva, CO2, etc.)
- Processing/storage of samples
- Physical measurements (ECG, Vitals, etc.)
- Data entry (Source Documents)
- Data Transfer (Case Report Forms)
- Data Audit (Quality Assurance)
- Data Analysis
- Preparation of Clinical Summary
- Report preparation.
PAYMENT OPTION
The charge for services and distribution of grant or contract funds
will be processed in the following manner:
1. Cost of individual CDS services as a subcontract.
The PI will provide the CDS with a statement of required services.
The services will be priced at cost +CDS operating overhead + University
overhead, if applicable. These amounts will be treated as a subcontract
.
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"Center for Drug Studies, Phase 1, Phase 2,
research,
pharmacokinetics, pharmacokinetic (PK), pharmacodynamics, pharmacodynamic
(PD), dosage form, safety and tolerance, clinical studies, new drugs,
biopharmaceutic, first-time in man, rising dose tolerance and safety studies,
single-dose vs multiple dose
pharmacokinetic (PK), bioavailability, bioequivalence studies, drug interaction
studies, 14C, 3H and 35 S Total Mass Balance studies, regional intestinal absorption
studies, intubation, intestinal transit
time of drug and dosage, pialtd, Willam H Barr, William R Garnett, PharmD,
PhD" |