Jim Robinson, M.S., Program Director

Innovative Clinical Research Solutions / Information Sciences Division (ICRS) of the Nathan Kline Institute (NKI) an organizational unit that specializes in clinical trial research support services. NKI clinical trial research support services personnel are involved in all phases of a clinical trial from initial planning to data dissemination

Because the collection, management, and analysis of clinical trial data are critical to the success of any clinical trial, a major component of the NKI clinical trial data management methodology is a comprehensive and flexible data acquisition and management system, Acquire EDC. . This system has been specifically designed for both single and multi-site clinical trials and to meet Good Clinical Practice (GCP) and Food and Drug Administration (FDA) requirements.

Acquire EDC is a web-based electronic data capture system that can be accessed from virtually any Windows PC with Internet access, and includes a comprehensive array of case report forms (CRFs) already programmed into the system. These screens are created to mimic paper CRFs for ease in transcribing data or for direct entry without paper forms. Over 400 CRFs exist for mental health and substance abuse clinical trials, and additional, customized screens are easily added. In addition to providing for the collection and management of study data, Acquire EDC provides investigators with powerful tools for the management of a clinical trial. The system's Subject Management feature allows the investigator to view visually, in real time, the progress of a clinical trial, to lock validated CRFs, and to issue queries. The system visually displays how many weeks or visits all subjects have completed, and allows the investigator, by clicking on a subject, to look in detail at which CRFs have been completed for that subject for each visit and to see which forms have errors, open queries, or are locked. An additional click from this screen displays any CRF for review or entry. The screen image below provides an illustration of the Acquire EDC Subject Management features.

ISD personnel develop all necessary data entry screens, study databases, data monitoring reports, standard operating procedures and provide data management training to clinical site personnel. Data is typically collected at one or more clinical sites, with real-time editing and storage. Further more complex and longitudinal editing and quality assurance analyses are performed each night and reports made available to clinical site personnel. Data Management, quality assurance and study management reports are available in real time to authorized personnel. As a final step, after the study is completed, data is converted to any of several formats (such as SAS or SPSS data sets, or flat files) for study analyses.

Data management is a key component of the NKI clinical trial research support services methodology. The role of data management is to review and track the data gathered from each clinical site in each research study. Data management personnel must ensure the timeliness, completeness, accuracy and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies. NKI data management personnel are key members of the multidisciplinary teams (often comprised of clinicians, research staff, programmers, quality assurance staff, and statisticians) involved in the development and implementation of research studies. The NKI Data Management Unit is comprised of Project Managers who lead the study teams, Data Managers, and Study Development Specialists.

The Information Sciences Division of the Nathan Kline Institute (NKI) also includes a Quality Assurance Unit. The Quality Assurance Unit is involved in initial study development and planning through study closeout. The Quality Assurance staff conducts site initiation, interim and closeout monitoring visits for clinical research studies to ensure data collection, protocol procedures, Good Clinical Practice (GCP), and regulatory compliance standards meet requirements. Monitoring reports are generated, which reflect the outcome of the visits and are distributed to the Investigator and Sponsor. Periodic data audits are conducted to ensure data is accurately entered into the study data acquisition and management system. Common trends are identified and reports are returned to the site. As necessary, other quality assurance activities include developing standard operating procedures, management reports, quality assurance plans, reviewing Case Report Forms (CRFs) and collaborating with the research team.

NKI is currently providing clinical trial research support services to several organizations including the National Institute on Drug Abuse (NIDA) as part of the Clinical Trials Network (CTN). NKI provides clinical trial research support services for several CTN Regional Nodes including the New York Node at New York University Medical School, the Rocky Mountain Node at the University of Colorado School of Medicine, Long Island Regional Node at Columbia University and the NYS Psychiatric Institute and the Northern New England Node at Harvard Medical School. NKI is also providing clinical trial support services to the Cognitive and Negative Symptoms in schizophrenia study, "Trial of D-Serene in Patients with Persistent Negative and Cognitive Symptoms of Schizophrenia" study, Treatment Units for Research on Neurocognition and Schizophrenia study, Columbia Child Psychiatric Intervention Research Center and the Methylphenidate Efficacy and Safety in ADHD Preschoolers Follow Up study.

For further information, contact Jim Robinson at