 |
| Contents & Topics |
Clinical
Studies Center Center
Personnel Services Policies for Conducting Human Studies Research at the VA Regulatory Binder Resources |
|
| Related Information |
|
Clinical Studies Center Services
The Clinical Studies Center (CSC) offers a variety of services
that help investigators ensure compliance with human studies regulations
and good clinical research practices.
These services include training and education for research staff,
assistance with Emory IRB and R&D Committee protocol submissions,
informed consent review and reformatting, and initiation of a Research
Clinics.
Read More |
|
|
|
|
The vision of the CSC is to be (i) a site for high-quality clinical research which is safe for patients and good for science, (ii) a resource where AVAMC investigators and coordinators can obtain assistance with all aspects of clinical research, and (iii) a high profile Atlanta VA clinical research contact for individuals and organizations outside the VA
The mission of the CSC is to be both a site for conduct of high quality clinical research, and an efficient, centralized resource for training, assessment of feasibility, and study design, that will attract research sponsored by both industry, disease focused groups, and the government.
In order to fulfill its mission and vision, the CSC will:
- Provide a physical facility which meets the full dimension of needs for clinical research – examination and interview rooms, phlebotomy, sample processing, storage and shipping.
- Identify and document “best practices” approaches to all aspects of clinical research – including but not restricted to regulatory compliance, informed consent, documentation, recruitment and retention, financial monitoring, and assessment and management of adverse events.
- Facilitate interactions among investigators and patients regarding different intramural and extramural research organizations and programs, e.g., intramural (VA Clinical Studies Program, VA Health Sciences Research and Development, etc.); extramural (National Institutes of Health, Atlanta Clinical and Translational Sciences Institute [ACTSI], etc.).
- Assist in providing research training and credentialing for investigators and coordinators.
- Assist investigators and coordinators in implementing “best practices” approaches for their specific studies.
- Assist in the design, development, pre-review, and revisions of protocols and informed consent forms, along with evaluation of feasibility and applications for research funding.
- Assist with the development of VA research clinics to track patient workload and protocol enrollment.
- Assist organizations outside the VA, desiring to have research studies conducted at the VA, in identifying VA investigators who might be interested in those studies.
- Assist with the regulatory requirements necessary to maintain compliance, and maintain close contact with the VA Research Compliance Officer.
- Assist in the liaison with OHRP, FDA, IRB, ORO, and other regulatory bodies.
Atlanta VA Clinical Studies Center
(151-CSC)
1670 Clairmont Road
Decatur, GA 30033
Phone: 404.327.4934
Fax: 404.417.2902
e-mail: csc@atlaref.org
View Individual Contact Details
|
|