Informatics Core

The mission of the informatics core is to facilitate and promote clinical research by working with researchers to provide consultation, assistance and direction on data acquisition, storage, retrieval, management. Supported with a variety of software and hardware, the Core provides GCRC investigators and their staff with tools and resources necessary to enter, maintain, and retrieve clinical research data.

Informatics Core-Operations (IC-O)

The Informatics Core-Operations (IC-O) provides services to investigators and administrative staff. The activities of IC-O are currently coordinated onsite by Dr. James Dziura and Mr. Charles Lu, based in the Yale Center for Medical Informatics (YCMI).

IC-O provides informatics support for: a) the multiple investigators involved in patient-oriented research using the GCRC; and b) administrative activities required by the Administrative Director of the Center. The focus of the IC-O is database design and management, programming, and computer systems administration including database servers, file server and desktop computers. Application/server software that is presently available in and maintained by IC-O for investigators and their staff include: SAS, SPSS, Office Suite, Project, FileMaker, CAMP, ARP, WebCAMP, and TrialDB, and Oracle and SQL server databases. University and contracted vendors provide other software. Here is the partial list of software and resources:

• SAS: http://www.yale.edu/software/sas
• SPSS: http://gdwbsrv.its.yale.edu/ris/statsoft.asp
• Microsoft Office product: GovConnection via Yale eportal.

Advanced Informatics Activities

The advanced informatics activities are based in the Yale Center for Medical Informatics (YCMI). The YCMI serves as a focus for training, research, and institutional computer systems development and support for a range of computing and informatics projects.

The advanced informatics activities build centrally on Trial/DB, a powerful, flexible, Web-accessible database that uses electronic case report forms (eCRF) to support clinical trials and clinical research. Trial/DB is currently being used at Yale to support clinical trials and clinical research in several clinical domains including cancer, cardiology, endocrinology, and psychiatry. Several Yale-based trials involve multi-institutional collaborations where data is entered from multiple sites nationwide using Trial/DB Web interface with appropriate security and confidentiality safeguards.

Close Ongoing Work with Study Investigators and Data Managers

Implementing protocols using Trial/DB involves working closely with the individual principal investigators (PIs) of the various studies and their data management personnel. This work includes: 1) teaching these individuals how to use Trial/DB; 2) working closely with them to help them enter their studies into our system; 3) refining the system as needed to accommodate the specific needs of their studies; 4) providing troubleshooting backup when any problems occur; 5) helping them in the process of monitoring the collection of their data throughout the course of each study; 6) adapting our tools to support their reporting needs; and 7) working with them to export their data into statistical packages such as SAS and SPSS for analysis.

The Clinical Investigation Website

The Clinical Investigation Website is a website designed and maintained by informatics. The website provides:

• Information and access to resources that will facilitate the successful conduct of clinical research
• Links to other websites, such as the Human Investigation Committee (HIC), and information to help navigate through these sites by focusing on, and describing, the information of direct relevance to investigators
• Templates and examples from other investigators for use in preparing grants, HIC protocols, consent forms, and other important documents
• Source of participants and controls
• Information on biostatistical and informatics expertise
• Information on negotiating access to and fees for research space, assays, imaging, and data collection

Data Management Guidance for Study Developers

As described above, we provide a variety of assistance for users who are preparing studies for which Trial/DB might be appropriate.

You may go to http://ycmi-crc.med.yale.edu/act_db to access System Requirements and User’s Manual for TrialDB.

For further information on Trial/DB, please contact Dr. Cynthia Brandt, cynthia.brandt@yale.edu (203) 737-5762 and Charles Lu, charles.lu@yale.edu, (203) 737-2982.