Conducting Research: Data and Safety Monitoring Board


The Research Track

Stops on the Track

    Research Navigation

 

    Before starting and during your research, there are training requirements that must be completed. Training

 

    Consider funding opportunities when thinking about your research idea. UIC has many opportunities to obtain funding for your project, as well as information on external funding options. Funding

 

    Some argue that the most important aspect of a research study is its design. Thinking through each step of the research process allows investigators to determine where additional resources may be needed, identify potential deficits in the study plan, and make changes to strengthen a proposal prior to its submission. Proposal Development

 

    Working through the Office for the Vice Chancellor for Research (OVCR), the Animal Care and Use Committee (ACC) helps you comply with federal regulations, state laws and University policies regarding the involvement of animals in research. Regulatory Research Requirements

 

    The Office of Business and Financial Services (OBFS) supports the business and financial operations of the University and assists units in their daily operations- including research studies. In research, OBFS is active in the Post-Award period. Common OBFS tasks include setting up anticipation and project accounts, and budgets in Banner. Award/Contract Processing & Acceptance

 

    UIC has specific personnel who receive, negotiate and accept industry sponsored research awards or contracts on behalf of you and the university.Industry Sponsored Research

 

    Award administration begins with your notification of the award and continues until the financial and technical closeout of your grant or contract is complete. Administering Research

 

    Assistance and guidance is available to help you operationalize and carry-out your research protocol. Conducting Research

 

    Numerous policies govern the management of data and records. The University offers a variety of resources to help you manage your data. Data & Records

 

    The University encourages your pursuit of scientific understanding and innovation. Services are available to encourage that innovation, help you prepare and publish your study and/or facilitate effective management, transfer, and commercialization of UIC technologies and your intellectual property. Results & Dissemination

 

    Research responsibilities do not end when results are published. You still have financial, final progress, and invention/patent reports as well as contractual responsibilities to complete. Award Closeout Procedures

    Data and Safety Monitoring Board
 

A Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) is a group of individuals with pertinent scientific expertise that:

  1. Reviews, on a regular basis, the accumulated research data from an ongoing clinical trial;
  2. Advises the sponsor and/or researcher regarding the continuing safety of trial subjects and those yet to be recruited into the research trial; and
  3. Advises as to the continuing validity and scientific merit of the trial.

A Data and Safety Monitoring Plan (DSMP) is a general plan contained in the research protocol to ensure the safety of the subjects and to ensure the validity of the data. The essential elements of a data and safety monitoring plan are:

  1. Monitoring the progress of trial and the safety of participants;
  2. A description of the mechanism for reporting unanticipated problems involving risks to subjects or others (UPIRSOs), as well as adverse events, to the IRB, FDA, sponsor, and NIH, if applicable; and
  3. Plans for assuring data accuracy and protocol compliance.

Review the IRB policy on DSMB and DSMP