DTCC Data Management Department
 

 

    
     
 

 

    
     
     
     
 
 
 

M. Theresa Perry, Director
 m.theresa.perry@rtrn.net
601-979-0336

  
     
     
     
 

DTCC Clinical Data Services and Informatics

  
 

 

  
 

The Clinical Data Services and Informatics Division is instrumental in coordinating the operations and activities for translational and multi-site research projects initiated by the various RCMI sites and assuring quality and efficiency. The division works cooperatively with the study teams and support personnel in the development, implementation and maintenance of standard operating procedures, processes and policies to ensure data management efficiency. The division keeps the study teams informed of project goals, long-term vision and initiatives and facilitates the content gathering for electronic Case Report Forms (eCRFs).

The DTCC has formed solid strategic alliances with experienced clinical data management, research and technology organizations, which are providing valuable direction and resources to further advance the efforts of the center. Since partnering with Duke Clinical Research Institutes (DCRI), a renowned institution with a 15-year history of successful clinical research service, DTCC has and continues to identify effective operational strategies

Clinical Data Services and Informatics Division provides the following services:

  • Protocol Development, Review and Submission
  • Ensuring Regulatory (ICH, FDA, IRB) Compliance
  • Electronic Case Report Forms (eCRFs) Creation
  • Data Management Plan Documentation
  • Electronic Data Capture (EDC)
  • eCRF Completion Instructions
  • Study-specific eCRF and Protocol Training and Support
  • Database Design, Validation and Testing
  • Management of Standard Global Libraries of Case Report Forms
  • Query Rules (edit checks) Development (data cleaning), validation and testing
  • Provide Standard Project Reports on Project Status and Compliance
  • Query Resolution Support and Rules Maintenance
  • Coding of Adverse Events (MedDRA) and Coding of Concomitant Medications (WHODRUG)
  • Laboratory Data Management
  • Database Freeze, Locks, Transfers and Quality Control
  • Mapping to CDISC Standards
 
 

Tools, Resources and Capabilities

 
     
 

M. Theresa Perry, BS, MA  (University of Louisville)
Director of Clinical Data Services & Informatics

More than 10 years experience clinical data management and data integration, including pre-clinical studies and animal models. Both IND and IDE experience. Therapeutic areas ranging from  allergies through transplantation and  oncology, all phases, from Ph I-IV and off-label. Relevant academia and CRO experience. Budgets, benchmarking and metrics development. Statistical analysis using SAS and SPSS. Standards development and use, including CDISC.   

Harold Graham, AAS (Lincoln Land Community College), BS (The University of the State of New York)
Clinical Data Manager II

More than 10 years experience in data management and more than 30 years nursing experience.  Relational data base experience, including Oracle Clinical Remote Data Capture. Site monitoring visits, site training, and documentation.

Srivinas J. Patkar, M. Tech (Dr. D. Y. Patil University), MS  (University of the Sciences in Philadelphia)
Bioinformatics Specialist RA

Expertise in Sequence data (Genomic & Proteomic), MicroArray Data (GeneSpring), Protein Structure, Post Translational modification study, Functional Proteomics, and coding in Perl, Unix, HTML, Open Source software and tools.

BoNita L. Harris, MPPA (Jackson State University)
Administrative Data Entry Technologist

Collects data in inventory management system, Provides feedback to Director, Resource Navigator/Data Entry Technologists for issues and resolutions, Maintains positive working relationship with site staff, core leaders, and Division leadership, Develops/maintains project documentation for data issues tracking and resolution, Point of contact for lab staff.

  
 

 
 

Data Management Tools

The RTRN Clinical/Remote Data Capture System consists of the following components: Clinical Data Collection and Management, online data capture, Adverse Events/Serious Adverse Events/PC Tracking and Reporting and Thesaurus Management System. These applications provide a single platform for both clinical data management and electronic data capture of Case Report Forms (CRFs). The applications provide additional functionality in key areas such as study setup, discrepancy management, lab data management and reporting. The Remote Data Capture interface was designed with the clinical site user in mind to facilitate ease of use during data entry. This benefit significantly reduces errors normally incurred during the paper CRF data entry process.

Thesaurus Management System (TMS) was specifically designed to handle the complexities of dictionary management including the multi-axial hierarchy of the MedDRA dictionary and the updates requiring version control. TMS can handle any dictionary or thesaurus and is integrated with both Oracle Clinical and the Oracle Adverse Event Reporting System. This integration ensures that coding occurs in a consistent manner across all systems.

 
 

 

  
 
     
     

 

   

Funding provided by:

     

RTRN DTCC    Mississippi eCenter, Box 1800       1230 Raymond Road        Jackson, MS 39204     (601) 979-0332