Monitoring the Quality of Clinical Inquiry Projects

Abstract

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