Electronic data capture User expectations, FDA needs critical before migrating.

NEW ORLEANS  Before companies migrate from manual capture of clinical data from paper to electronic data capture (EDC), they must gauge "user requirements," in this case clinical investigators and supporting personnel, who are generally more accustomed to paper, a computer vendor told a conference by the Chicago-based International Quality and Productivity Center.

But executives also said industry also has to be mindful of another key "user" FDA. They said the interface with agency rules such as Part 11 must be part of the migration process.

Robert van Manen, worldwide technical director for CLIN-SOFT, Lexington, MA, acknowledged that speed and accuracy are often the most apparent benefits of any automated system. The ability to collect data at the source, thus eliminating mailing delays, allows for faster availability of clinical data, faster communication with the investigator site, and immediate feedback on errors and queries.

EDC provides cleaner data

John Hutchin, manager of technical consultants at CLIN-SOFT, added:

"With EDC, you get cleaner data because of on-line edit checks. These edit checks require accurate data entry in order for the data to be processed."

However, van Manen noted that "too many edit checks can frustrate your users because it slows them down." He stressed the importance of finding a balance between validation and performance.

The non-technical challenges of EDC are those involving user perceptions. The successful EDC model, van Manen stressed, must reflect the way the user actually works. This could mean supporting a doctor who enters data directly into the on-line system, or one who writes the data on a paper form for a clerk to enter later.

Encouraging the user to take part in system design promotes understanding of his requirements. "Users want intuitive navigation and adequate feedback when submitting data to the server. Investigators are very concerned about where their data goes," van Manen said. "Investigator and sponsor acceptance is crucial to the success of any EDC solution."

Some workshop attendees noted the importance of raising realistic expectations to management and end-users about the capabilities of automated systems.

Although EDC certainly has the potential to increase speed and efficiency, if paper forms are used as an intermediate storage before data is entered into the system, delays and human error may still be introduced.

If an application is going to transmit data over the Internet, security becomes a very real concern. Electronic signature is one solution to the problem of data being modified or read by the wrong party during transmission.

Van Manen defined electronic signature as "an electronic piece of information that represents somebody's legal responsibility for data that is transmitted or stored...if somebody has attached an electronic signature to a piece of data, he takes legal responsibility for that data."

The most common means of implementing an electronic signature is a digital signature, which is a code based on the contents of the piece of data.

If someone attaches an electronic signature to a piece of data, he takes legal responsibility for that data, Van Manen said... "It guarantees the data being transmitted is really coming from the person who says he is sending it, and that it hasn't been modified," van Manen said.

Noting this also comes under Part 11, Kyle McDuffie, director of quality assurance for CB Technologies, cautioned that FDA requires data available locally at all times. In the case of an on-line system, the user must be able to access the data even if the network is down. "Online data solves some issues, but creates others," McDuffie said.

Offline systems, however, present data security and data integrity issues. The local user becomes responsible for physical protection of the data. Furthermore, if a secondary database is maintained, those databases will need to be synchronized in order to keep the data consistent.

McDuffie reminded the participants that "technology itself does not necessarily guarantee increased speed or accuracy. We often need to change our business practices to take advantage of technology," he said.

Standards and EDC

A key facet of EDC in clinicals concerns standards. At the meeting, there was much discussion of the new Clinical Data Interchange Standards Consortium (CDISC), a not-for-profit organization developing industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.

Nexigent a subsidiary of Covance, announced May 1 it will participate in CDISC. The consortium's goal is to leverage these standards to improve data quality and decrease drug development time and cost. As a full corporate sponsor, Nexigent is to be involved in CDISC working groups and provide funding for CDISC activities. Nexigent provides technology-enabled services to accelerate and improve drug development.

It is working with Covance's Central Laboratory, the world's largest laboratory dedicated to clinical trials, to accelerate the availability of clinical lab data for pharmaceutical customers by leveraging Nexigent's systems and Internet portal.

Nexigent said its technical team will provide additional services to CDISC by lending their experience in clinical lab data management and technology expertise to help CDISC document models and lab processes.