Clinical Trial and Other Clinical Research Protocol Supporting Data Management Systems

The Clinical Research Informatics and Data Management Unit of the Center for Health Informatics and Bioinformatics has substantial expertise and experience in providing clinical research study data management and systems development services. With an emphasis on the collection, management, and integrity of clinical research study data, the Unit employs comprehensive yet flexible clinical study systems development and data management methodologies. Using eVelos, clinical research study electronic data capture (EDC) systems are designed to meet the specific needs of each study. The system can also meet the requirements of Good Clinical Practice (GCP) and the Food and Drug Administration (FDA) requirements. The primary goal of this unit is to assist Principal Investigators and clinical study teams in improving the efficiency and effectiveness of conducting their clinical research.

This unit provides the following services:

• Development of a system development plan with tasks and deliverable deadlines

• Development of Case Report Forms (CRFS) if paper forms are used to collect data

• Development and validation of a complete data acquisition and management system using eVelos that includes data entry screens, comprehensive editing of data online and the immediate storage of data in the study database

• Development and validation of study reports including reports for Data and Safety Monitoring Boards (DSMBs) and other regulatory agencies

• Development and validation of data import programs for any external electronic data

• Development of a data management plan specifying all activities required to maintain the integrity of study data

• Provision of data management and eVelos EDC system training to all clinical research personnel

• Conduct of ongoing data management and cleaning of the clinical study data including primary outcomes and safety data as well as a review of validation errors, missing records, query resolution, and locking of EDC records

• Generation and resolution of data queries on any questionable data

• Monitoring of all data for timeliness, completeness and accuracy

• Conduct of data management teleconferences with clinical research personnel

• Provision of a cleaned and locked database for the study statistician or designee in agreed upon format.

• Assistance as requested with the preparation of the reports for the sponsor or other parties

This unit will also provide educational seminars to assist clinical research personnel in keeping abreast of the global changes and issues in clinical research systems and data management. Unit personnel are also available to work with investigators in the preparation of grants and proposals.

If you would like more information or wish to discuss support for clinical research study data management or services, please email Jim Robinson at James.Robinson@nyumc.org or robinson@nki.rfmh.org or call (845) 398-6505.