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The Discovery DCC shall be responsible for the communication, coordination, storage, maintenance, and integrity of data collected from all sites involved in a study. The Discovery DCC shall also have primary responsibility for statistical analysis to support the study. The study PIs shall work closely with Discovery DCC staff to provide general direction, oversight of adverse event reporting, and data presentation and may carry out additional aspects of administrative, clinical, and technical expertise and leadership in study design and coordination in collaboration with the DCC and PIs.
The Discovery DCC is directed by Douglas Landsittel, PhD, Professor of Biomedical Informatics, Biostatistics, and Clinical and Translational Science at the University of Pittsburgh. Dr. Landsittel has over 20 years' experience in collaborative, educational, and methods research. Learn more about Dr. Landsittel and other team members.
The Discovery-DCC is directed by Douglas Landsittel, PhD, Professor of Biomedical Informatics, Biostatistics, and Clinical and Translational Science at the University of Pittsburgh. Dr. Landsittel has over 20 years of experience in collaborative, educational, and methods research. He has published over 130 peer-reviewed manuscripts and has served as a principal investigator (PI) on a National Institute of Diabetes and Digestive and Kidney Diseases-funded data coordinating center, an Agency for Healthcare Research and Quality-funded R25 grant on methods in patient-centered outcomes research, and a Patient-Centered Outcomes Research Institute-funded contract on causal inference methods. Dr. Landsittel has been appointed to both National Institutes of Health and Centers for Disease Control and Prevention study sections. He has served as chair on multiple reviews and is a member of several expert panels. Program Manager: SCCM has a full-time program manager on staff. The program manager’s primary responsibility is to oversee research projects from conception through final reporting, which may include overseeing individual research projects from pre-award through post-award, tracking project timelines and budget compliance, maintaining records and reports on project status, and working as a liaison between the PI, other investigators, and project leads. Database Administrator: SCCM has a full-time research database administrator who is responsible for the performance, integrity, and security of SCCM’s research-related database. Research database administrator consultation services are offered in the following areas:
The Discovery DCC uses Research Electronic Data Capture (REDCap) Cloud for research that requires data collection. REDCap is a secure, web-based application designed to support data capture for research studies. REDCap Cloud is compliant with FDA CFR Part 11, HIPAA, and EU Annex 11 regulations.
The Discovery-DCC uses Research Electronic Data Capture (REDCap) Cloud for research that requires data collection. REDCap is a secure, web-based application designed to support data capture for research studies. REDCap Cloud is compliant with FDA CFR Part 11, HIPAA, and EU Annex 11 regulations. REDCap Cloud includes the following security features:
The Discovery Steering Committee is responsible for developing and implementing procedures to ensure integrity in several areas.
The Discovery Steering Committee is responsible for developing and implementing procedures to ensure integrity in the following areas Clinical informatics: Oversight and mechanics of collecting, managing, reporting, securing, and protecting Discovery research data and ensuring research data integrity. Data and safety monitoring: Ensuring monitoring for each Discovery research activity, if appropriate based on the type of research being conducted. IRB, including a central IRB: The purpose of an IRB is to ensure that appropriate steps are taken to protect the rights and welfare of human participants in a research study. A central IRB reviews research studies for multiple sites. A central IRB is a single IRB of record for a given protocol. The Discovery Steering Committee will ensure that an independent central IRB is selected for each project unless an individual IRB approach is taken by the research work group. Before a clinical trial begins, the protocol (study plan) must be reviewed by a group of experts not connected with the research to ensure that it is ethical, provides potential benefits, and does not cause unnecessary harm to participants. Data policies and intellectual property: Any and all results and inventions from research and development in connection with Discovery programs will be detailed in a written agreement by all study participants before the project begins, including but not limited to intellectual property rights such as technical information, expertise, patent application rights, patent rights, data ownership, copyright, and trade secrets. Creation of public use data: Data from Discovery studies constitute an important scientific resource. To enhance the public health benefit of these studies, public use datasets may be made available to qualified researchers. Discovery public-use datasets will generally be made available after initial study completion, in accordance with Discovery procedures. Discovery datasets will be provided only to those secondary investigators who agree to adhere to the signed research data use agreement (RDUA). Data will also be created for NIH or other repositories as required by specific programs. Execution of an RDUA will require approval by the investigators’ relevant IRB or demonstration of exemption from the need for IRB approval by institutional policy. Dataset creation and distribution will be performed by the Discovery-DCC.
Early collaboration with the Discovery DCC is critical for optimizing the potential for success, beginning at the earliest phase of study conceptualization.
Early collaboration with the Discovery-DCC is critical for optimizing the potential for success, beginning at the earliest phase of study conceptualization.
Depending on the type of study and/or proposal, some of the activities in Table 1 may not be entirely applicable to your study.
Table 1. Outline of phases of collaborative activities for funding submissions
REDCap Cloud case report forms (CRFs) will be used to screen, enroll, and randomize subjects. The DCC will track enrollment and other results for transparent reporting, including the number randomized to each study arm and reasons for exclusion or loss to follow-up. The number enrolled by each site and the number randomized into each study arm will be provided in data reports to the study PI.
REDCap Cloud CRFs will be used to screen, enroll, and randomize subjects. The DCC will track enrollment and other results for transparent reporting, including the number randomized to each study arm and reasons for exclusion or loss to follow-up. The number enrolled by each site and the number randomized into each study arm will be provided in data reports to the study PI. The reports will include:
REDCap Cloud CRFs will be used to screen, enroll, and randomize subjects. The data coordinating center will track enrollment and other results for transparent reporting, including the number randomized to each study arm and reasons for exclusion or loss to follow-up. The number enrolled by each site and the number randomized into each study arm will be provided in data reports to the study PI.
REDCap Cloud CRFs will be used to screen, enroll, and randomize subjects. The data coordinating center will track enrollment and other results for transparent reporting, including the number randomized to each study arm and reasons for exclusion or loss to follow-up. The number enrolled by each site and the number randomized into each study arm will be provided in data reports to the study PI. The reports will include:
Budgeting for sufficient effort is critical. These recommendations represent broad guidance on how to budget for Discovery DCC personnel.
Having sufficient effort budgeted is critical for several reasons:
The recommendations in Table 2 represent broad guidance on how to budget for Discovery-DCC personnel.
Table 2. Proposed effort of Discovery-DCC personnel on funding proposals These efforts are approximate.
The final efforts are based on the needs of the individual investigators.