Quality Assurance of Clinical Data in a Remote Data Entry Environment

Abstract

Quality Assurance (QA) of remote data entry must be devised to complement the QA of clinical data acquired by traditional (conventional) means. The conduct of a clinical trial from conception through completion is marked by a rather extensive and evident paper trail: plan, protocol, brochure, patient records, laboratory slips, miscellaneous notes and records, case report forms, tabulations, analyses, and reports. The case report form is the medium for transmitting the data from the investigator to the sponsor. Except for the case report form, all other elements of a clinical study should be present even when the data are transmitted electronically from the investigator to the sponsor. In fact, items generally considered as “raw data”—patient records, laboratory slips, and miscellaneous notes and records—acquire additional importance to document the clinical study.

In this article remote data entry is defined as the transmission of clinical data directly from an investigational site to the computer of a sponsor by electronic media, whether by hard wire, telephone linkage, or on tape or diskette. This does not include the tranmission of facsimile case report forms.

The potential for error, lost data, and fraud is much greater when data are sent directly from the investigational site to the sponsor's computer. It is the function of clinical QA to anticipate the problems, devise ways to avoid them, and to be able to detect them if they should occur. The place to start is when the program is first planned. Quality assurance should evaluate the planning, execution, and documentation of any study using remote data entry as the means to capture and record the data.