Data Coordinating Center University of Washington Department of Biostatistics Elizabeth Brown, ScD Siiri Bennett, MD

From the DCC RFA Provide support to individual participating studies Promote sharing of mathematical models and software Facilitate collaborations and integration of projects so group can conduct joint protocols – Provide leadership for identifying common data elements, standardizing definitions, harmonizing data and developing joint protocols – Provide design, statistical and organizational support – Develop and maintain common datasets – Provide data management, including QC and QA – Reserve $80,000/year direct costs for joint research Implement a web-based system to coordinate joint project activities

From the DCC RFA (cont.) Prepare public-use files for disseminating, archiving and sharing results of projects according to NIH/NHLBI policies Support specimen banking activities as needed Arrange meetings and conference calls and draft and post minutes Track progress of publications Provide administrative and organizational support services – For outside scientific advisory committee – For Observational Study Monitoring Board (OSMB)

DCC Proposal Aim 1: To provide statistical support for protocol development and manuscript and presentation preparation Aim 2: To implement and oversee data collection and management as necessary for successful implementation of the study goals Aim 3: To promote and facilitate collaboration between the individual studies Aim 4: To administer and coordinate all study activities for successful implementation of study goals

Aim 1: Provide statistical support DCC will provide statistical support to study investigators and NHLBI Project Office as requested DCC will be available to conduct statistical analyses of data

Aim 2: Implement and oversee data collection and management Using LabKey Server, a web-based data management platform that integrates observational, genomic, proteomic and flow cytometry data, the DCC will – Provide web-based data sharing capabilities that are secure & password protected – Provide message boards, issue trackers and wikis Upon establishment of data collection schemes for each study, DCC will: – Design central database structure and compile a data dictionary – Establish and maintain server configuration and system platform – Work with each study site and laboratory to establish data transfer processes and applications required for electronic transfer of results data – Work with study investigators to develop a QA program – Implement a QC plan to ensure data quality during data collection

Aim 3: Promote and Facilitate Collaboration DCC will develop and maintain a central web-based information center for disseminating all study-wide communications and allowing interactive input from all sites – External website, serving the general public – Internal website, serving project investigators – Internal website for the Scientific Advisory Board – Internal OSMB members’ website Website will serve as the primary information and data exchange – Each study’s platform, study design, size and data complexity will be reviewed and assessed for capabilities for file transfers – DCC will post software and math models in the internal and external study websites

External Website Serving the general public, to provide general information, including: – Project description and rationale – Contact information for study sites and staff – Study protocols – Target dates for release of data to outside researchers – Policies and procedures for use of data – Search capability – Software developed by study participants

Internal Website Serving study investigators, to facilitate communication and share information, this will include: – Bulletin boards and interactive project space for working groups – Data documentation, including study protocols and manuals – Access to data/downloads – QA/QC activities – Description of statistical methodologies and analysis recommendations – Software updates as needed – Dynamic reports for tracking study progress and preliminary data – directory of project staff – Calendar of project deadlines, meetings, and call schedules – Reports – Links to other websites of interest – Search capability

Aim 4: Provide Administration and Coordination Organize and facilitate group meetings and calls Oversee shipping of biological samples to NHLBI repository as directed by NHLBI Facilitate and track publications and presentations Consistent with NIH policy, create public use datasets with appropriate documents for external investigators Facilitate data harmonization – Review data elements being collected by each individual study – Identify elements common across studies and determine feasibility of data harmonization – Apply agreed algorithms to each study’s data to recode the data into a common format – Incorporate each study’s data, data dictionaries, individual-level consent codes and other relevant data into a harmonized database

Data Coordinating Center Key Personnel: Elizabeth Brown, ScD Siiri Bennett, MD Katie Kerr, PhD David Levine, PhD