ENT diseases adversely affect the HRQOL in patients visiting their otolaryngologist. Clinical and demographic variables are important considerations in the measurement of HRQOL.

Conducting randomized controlled trials entails a prolonged, costly study start-up (SSU) process that may create significant delays. Optimizing the operational aspects of multisite trials requires identifying benchmarks in the SSU process and the potential delays associated with them. We engaged in a collaborative effort to identify and describe key SSU intervals that correspond with necessary procedures and processes for activating multisite clinical trials in the US. After developing definitions for SSU benchmarks and obtaining data from research coordinating entities, we identified factors that were significantly associated with reduced cycle times, including the use of central institutional review boards for study approval and status as a private practice or independent research site. However, small sample sizes and large proportions of missing data hamper the interpretability of our results. Future development of standard measures of SSU efficiency will be critical to analyzing and improving study initiation processes at US research sites.

The results from this study can be used to guide the design of future acute care electronic health information display. Additional research and collaboration is needed to refine and implement intelligent graphical user interfaces to improve clinical information organization and prioritization to support care decisions.

Project management expertise is employed across many professional sectors, including clinical research organizations, to ensure that efforts undertaken by the organization are completed on time and according to specifications and are capable of achieving the needed impact. Increasingly, project leaders (PLs) who possess this expertise are being employed in academic settings to support clinical and preclinical translational research team science. Duke University’s clinical and translational science enterprise has been an early adopter of project management to support clinical and preclinical programs. We review the history and evolution of project management and the PL role at Duke, examine case studies that illustrate their growing value to our academic research environment, and address challenges and solutions to employing project management in academia. Furthermore, we describe the critical role project leadership plays in accelerating and increasing the success of translational team science and team approaches frequently required for systems biology and “big data” scientific studies. Finally, we discuss perspectives from Duke project leadership professionals regarding the training needs and requirements for PLs working in academic clinical and translational science research settings.

N urses participating in unit-based research or quality-improvement projects are not traditionally trained as research coordinators. Although they may be experienced in collecting data as a usual part of patient care responsibilities, nurses typically are not responsible for managing data in an electronic database or formally monitoring the quality of data that are collected. Nurses also may have limited exposure to and experience with federal regulations surrounding the collection of data from human subjects, including patients, family members, or community participants. Such federal regulations are implemented in the clinical setting through the governance of the institutional review board. When these data are used for quality improvement or research, they take on new meaning. Unintentional disclosure of patient identification is an example of misuse of data that carries with it both legal and ethical implications. One way to educate nurses about regulations that govern the processes of clinical inquiry, and thus remove some of the mystery of the regulatory processes, is to involve them in monitoring activities. The purpose of this column is to describe the components of monitoring for clinical inquiry projects to facilitate nurses' understanding and involvement in the process.Research monitoring is the planned, ongoing process of reviewing data collected in a study or clinical trial, with the primary purpose of protecting the safety of study participants, the credibility of the study, and the validity of study results. 1 Monitoring is also a good practice for local quality-improvement or unit-based studies that are not formal clinical trials. The depth, scope, and frequency of monitoring should be commensurate with the study's size and complexity as well as the relative risk to subjects. Establishing a quality-monitoring plan is an essential component of good clinical practice in the conduct of research and is also recommended for quality-improvement projects.The monitoring plan may be different from project to project and should include a review of (1) the integrity or quality of the data being collected for analysis, (2) the processes of data collection that support the safety of subjects, (3) the overall compliance with regulatory requirements, and (4) the access to and storage of data, in both paper and electronic format. In clinical trials, monitoring is often performed by personnel contracted by the sponsor and is performed during periodic site visits over the course of the study. For unit-based research