Data and safety monitoring during randomized controlled trials of nursing interventions.
BACKGROUND
Principal investigators have a responsibility to ensure and maintain the scientific integrity of their research studies and to protect the safety of the participants. Data and safety monitoring is required for all types of clinical trials, and the nature and degree of the monitoring must be related to the degree of risk involved.


OBJECTIVE
This article aims to define the purpose of a data and safety monitoring board (DSMB), to describe the functions of a DSMB and distinguish them from the activities of an institutional review board, and to discuss the development and implementation of a DSMB plan.


METHODS
The literature on data and safety monitoring is reviewed, and the process and key issues are illustrated with examples from the authors' clinical trial and others.


RESULTS
The principal role of the DSMB is to monitor the data from the trial periodically, to review and assess the performance of its operations, and to make recommendations based on interim results (e.g., modification of the study protocol, or possible early termination of the study). Although the roles of a DSMB and institutional review board complement one another, the main focus of their responsibilities is different and carried out independently of one another. The members of a DSMB are selected on the basis of their methodologic, statistical, or clinical expertise.


CONCLUSIONS
The multiple scientific, ethical, safety, recruitment, intervention, and budgetary responsibilities of a principal investigator can be complex. The role of the DSMB is crucial and offers independent evaluation to ensure participant safety and good science.
Artinian
Nancy T
NT
College of Nursing, Center for Health Research, Wayne State University, Detroit, Michigan 48202, USA.
Froelicher
Erika Sivarajan
ES
Vander Wal
Jillon S
JS
D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D003625:Data Collection / Q000592:standards; D003627:Data Interpretation, Statistical; D006801:Humans; D020380:Needs Assessment; D015403:Nursing Evaluation Research / Q000592:standards*; D009937:Organizational Objectives; D010934:Planning Techniques; D016730:Program Development; D016032:Randomized Controlled Trials as Topic / Q000451:nursing / Q000592:standards*; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment / Q000458:organization & administration; D012449:Safety / Q000592:standards*