Core D will provide logistical, regulatory, and research data management support for all clinical trial projects conducted under this grant application. It will maintain a comprehensive BMT repository database on all patients undergoing allogeneic HSCT, and ensure HIPAA compliant release of clinical outcomes data to researchers for correlation with their laboratory findings. The ultimate objective of this program project application is to understand the pathophysiology of chronic graft-vs.-host disease (GVHD) in humans. The focus of all projects is to develop targeted strategies that can prevent and control cGVHD. Core D will be responsible for the complete and accurate collection of individual patient data for all the clinical studies in this grant. Clinical data on patients collected through core D will be available to investigators in other cores so that they will have clinical correlates for their laboratory observations. Integrated data management is critical for all clinical projects and extend beyond patient care and clinical laboratory functions. Core D will coordinate the proper collection of detailed patient-level data in the BMT repository database, and assure that the highest quality data are available to achieve laboratory and clinical objectives. This core will interact extensively with staff from the Biostatistics Core C who can retrieve data directly from the BMT repository for correlative analyses. Core D will work closely with Core C to provide assistance in study design and analysis for the Projects. The purpose of the Data Management Core D is to provide the following services that will be utilized by all three Projects: 1. To help clinical and laboratory investigators identify the necessary patient-level information for their projects, and to design forms, procedures and databases to capture these data 2. To provide clinical data management for abstraction of individual patient information 3. To provide clinical trials with regulatory binder support and quality control for clinical data 4. To assure patient confidentiality and HIPAA compliance in the release of personal or clinical information from the HSCT repository to investigators who need this data for clinical correlation with their laboratory findings.
All research projects in this application require coordinated clinical data in order to answer their respective scientific questions. It is the responsibility of Core D to provide complete support to the projects for these needs so that collection of patient information is timely, complete, of high quality, and immediately available for analysis.
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