Remote data entry, clinical trials

Web-based data collection and management systems provide a mechanism for remote data entry, where entered data are added to a centralized database once the submit button is pressed. They can be designed to automate the various aspects of clinical trials such as eligibility evaluation, data collection, and tracking specimens. They also serve as a resource site for participating sites to access trial-specific information, facilitate communication, track data queries and their resolutions, and allow administrative management of trials [28, 29]. For these reasons, they play an important role in facilitating the conduct of international clinical trials. 

Before a clinical trial starts, the use of technical aids such as IVRT, remote data entry and electronic diaries has to be considered. In Section 7.5.3.3, mention will be made of the use of electronic tracking system that provide status and monitoring reports. All these systems utilise computer systems that must be validated. Double and McKendry described computer validation as the process which documents that a computer system reproducibly performs the functions it was designed to do. The document Guidance for Industry - Computerised Systems used in Clinical Trials published by the FDA in 1999 gives clear recommendations of what is required (also see Section 7.5.4.1). 

There have been numerous advances in the area of remote data acquisition. Data can be collected at the site via an electronic CRF or a hand held electronic device. These data can then be transmitted back to the sponsoring company and batch loaded into the sponsor s clinical trial database. Remote data entry technology currently allows for the easy definition and distribution of the electronic CRFs to the investigator site. Some online cleaning can be performed as the data are entered before transmission to the sponsor site, where additional quality checks are applied and transmitted back to the investigator site. This iterative process allows for collection and generally... 

CRF audits should also be conducted on a draft version, just before finalization of the CRF. As the CRF is the data collection tool in a clinical trial, errors and inconsistencies in its contents and design and inconsistencies with the trial protocol may lead to serious problems if they are not identified prior to the CRF being used. This holds true for paper CRFs and electronic CRFs, as well as the use of remote data entry (RDE) or web-based data collection and transmission tools. The latter requires careful consideration of related guidelines (FDA 21 CFR Part 11 FDA Guidance for Industry, 1999). 

Regulatory Affairs Professionals Society Research Coordinating Committee (CDER) Remove Clinical Hold Randomized Clinical Trials Response to Request for Information (COMIS term) Remote Data Entry... 

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