Sage Journals: Discover world-class research

Abstract

Technology to streamline clinical research is advancing largely in three focal areas: electronic submission, electronic data capture; and applications for process improvement and management. New technologies are also ideal for providing the communication infrastructure to create ‘virtual teams’ from distributed members through a new type of ‘connectivity’ that also supports the trend in our society toward diminishing timeframes for such communications.

When considering the functional composition of the clinical research team, common roles typically include the site/study coordinators, the monitors/clinical research associates (CRAs), the project manager(s), data manager(s), and possibly a medical monitor or a client representative if the trial is conducted by a contract research organization (CRO). Rarely is the institutional review board (IRB) included. The central IRB (independent or medical center consortia-based) can serve as a valuable resource to teams, individually and as a whole. Flows of information involving the IRB most amenable to technology are: Initial submissions to the IRB, informed consent documentation, continuing reviews/final reports, and adverse events.

Keywords

IRB Technology Process improvement

Get full access to this article

View all access options for this article.

References

Food and Drag Administration. FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format. Rockville, MD: US Food and Drug Administration; January 1999. Available at www.fda.gov/cder/guidance/index.htm.

Food and Drug Administration. FDA Guidance for Industry—Computerized Systems Used in Clinical Trials. Rockville, MD: US Food and Drug Administration; April 1999. Available at www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm.

Federal Register. FDA, 21 CFR 11, “Electronic Records; Electronic Signatures; Final Rule; Electronic Submissions; Establishment of Public Docket; Notice.” Available at www.fda.gov/cder/esig/part11.htm.

Blake

Pinkston

Electronic reporting of adverse event data to the Food and Drug Administration: the experiences of Glaxo Wellcome and Zeneca as participants in the Adverse Events Reporting System Pilot Project. Drug Inf J. 1999;33(4):1102.

Electronic Issues for IRBs: Administrative and Regulatory

Abstract

Keywords

Get full access to this article

References