Data Acquisition and Analysis. Specific activities of the DMC include entering and processing data from case report forms, developing and maintaining an effective study database and its associated query system, maintenance of a computer environment sophisticated enough to manage extensive study databases, developing and producing regular reports on the accuracy and completeness of the study database, participant tracking and study development We will also work in conjunction with Rush Infonnation Services to design and host the participant web site. The collegial relationship that exists between the DMC and the proposed research team will support the ready exchange of any needed resources. All interviewer administered questionnaire data will be collected in Blaise? software on laptop computers. In order to ensure our participants health information is secure no participant identifiers will be collected on the laptops, it will instead be collected on case report forms separately. All data collected on case report forms will be entered using Microsoft (MS) Office Access as a front end. All data collected either through Blaise? or case report form will be stored in a secure MS SQL Server Relational Database which will be on the Preventive Medicine Biostat Server. The MS SQL Server database system has the ability to deal with large datasets, perform checking for logical inconsistencies and organize the data for analysis. Microsoft Access will be also be used to generate scheduling, tracking and monitoring reports for the study. Permission controls and passwords will assure that only authorized personnel have the ability to access study data. The database programmer will assign permissions on an as-needed basis. Confidentiality of data on the Biostat Server is protected by 2 levels of control: (1) the Rush network has a firewall and access is limited by a Secure ID;(2) entry into the Biostat Server, MS SQL Server and MS Office Access are all protected by passwords. The Server is backed up nightly by the Information Services department using Veritas Backup software. All paper forms will be stored in secured areas such as rooms or file cabinets with controlled access (e.g. locks). The DMC will work with study staff and labs involved in analyzing study samples to ensure accurate transfer of study data from the labs to the DMC. The DMC will identify any results deemed critical by study protocol, and work with study staff to implement the safety measures detailed in the individual study protocols. All qualitative data will be collected through notes, digital voice recorder, and or digital video camera. Adobe Premier Pro will be used to help with the transcription of the qualitative data, and all transcriptions will be carefully documented and stored on the Preventive Medicine Biostat Server in a limited access folder. The DMC will create and host a website, part of which will be open to the public and contain general information and another part consisting of a private and secured portal to be used for study-specific data entry and reporting. This Center website will have individual portals that will be customized according to study needs and serve as on-line repositories for study-related information and documents. Microsoft SharePoint Server allows for extensive content management, information dissemination, and collaborative efforts (e.g, workflows for document preparation). To ensure the highest level of protection, IT hosting is done through Rush University Medical Center's Information Services department which supports all three critical areas of data security (physical, operational, and system), ensuring maximum protection of data. To ensure the highest level of protection, participant information stored on the website will be displayed in protected Portable Document Format (PDF) behind a password protected and encrypted firewall. Primary care physicians and other intervention staff that need to have access to this information will be limited to the smallest amount of participant data needed for the study to function successfully. The DMC will work with the Steering Committee and study staff to make the website helpful to all. The public component of the website will include: descriptions of individual studies, a dynamic bibliography of publications linked to PubMed?, Center and study press releases, upcoming public events/talks, Center contact information, as well as general information. In addition, this section of the Center website will serve to facilitate media relations between the Center and the public. To this end, we will include a comprehensive FAQ area that includes the Center's over arching mission and purpose as well as information and media releases provided to the public by NHLBI. The DMC will implement randomization procedures for all studies in the Center. Knowledge of participant randomization assignment will be restricted to minimal DMC staff and study personnel who require such information to optimally implement the study protocol and ensure participant safety. Dr. Richardson, the Chief Study Biostatistician, will be the sole arbiter of which study staff are provided such access. Dr. Richardson will also oversee all issues with respect to the analysis and reporting of study data. As such, he will be responsible for the integrity of all data analyses, ensuring that they correspond to the pre-determined analysis plans, and all communications (with respect to data analysis) between the Center and any impaneled DSMB. The DMC will help the steering committee coordinate the cross-center common elements, as we will ensure that all elements are collected in the agreed upon protocol and format. The DMC will create any requested data sets for statistical analysis and quality assurance using SAS and Microsoft Access and SQL server. Quality Assurance. Quality assurance checks will be implanted at the time of data entry to ensure data accuracy. In addition, the DMC will perform quality assurance checks and will prepare and distribute a variety of status reports at regular intervals (some weekly, and others monthly, as circumstances and requirements dictate) throughout life of the study. If any of the checks fail, a query will be generated and distributed to the staff in a timely manner for resolution. The DMC will work with study staff to monitor any adverse events that occur in any of the studies under the center. While the administrative core will report any adverse events to the prerequisite IRB's, the DMC will complete reports of any serious adverse event and immediately forward to the chair of the DSMB. The DMC will also work with the DSMB to provide any other information they may request.
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