The information captured in clinical trial systems may be based upon an electronic source, such as an EMR. Unfortunately, clinical researchers cannot use many of today's EMRs and EHRs because of the variability among health record systems and the lack of conformance to clinical trial regulatory requirements. Therefore, very often, the data stored in EMR systems has to be printed or hand-transcribed and re-entered into the EDC system.

That may help explain recent survey results from the Clinical Data Interchange Standards Consortium: Despite the advantages of online data-discrepancy management, streamlined archiving, and other tools contained within major EDC systems, 25 percent of sites surveyed believe EDC is increasing their workload. And as the use of EHRs increases, the perception that EDC is an added burden also will increase.

There's also the problem of capturing trial-specific data that is not typically recorded in patients' charts or electronic health systems. This means, to stay compliant with regulations, investigators often must create a second "source," an alternative record-keeping system in addition to their EMR system.

Not as Easy as It Looks

eSource: Rules and Regs

Point-of-care data-collection processes Healthcare is under tremendous time and cost pressure. And while EHRs document and facilitate the management of individual patient care delivery, it may still be inefficient and costly for hospitals or physicians' offices to carry out the meticulous documentation processes that are common in the pharmaceutical industry.

If data in EMR/EHR systems are used as eSource for clinical trials, investigators will have to apply authority checks (as expected under 21 CFR Part 11) to ensure that only authorized persons can access the system, and an electronic audit trail will be required.

This will likely clash with common practices in small physicians' offices, such as using generic user names or sharing passwords with multiple staff. It will also force many companies to modify EMR/EHR products to include audit-trail capabilities compliant with clinical research. Many have speculated that, without appropriate encouragement and incentive, enforcement of requirements like audit trails may slow doctors' adoption of health records.

Source data are far from perfect Depending on the circumstances of healthcare delivery, the quality of the records may suffer. In emergency situations, for example, ambulance and emergency room staff will always focus more on rapid intervention than accurate record keeping.

Further complicating the picture, a variety of staff—physicians, nurses, phlebotomists, etc.—play a role in recording patient information. That data is then subject to the professional judgment of the physician responsible for writing the discharge summary.

But the question of source data must still be tackled: Should the notes from each of the consecutive caregivers be considered source data or just the summary from the overseeing physician? FDA's Division of Scientific Investigation (DSI) representatives acknowledged this ambiguity when they met with the PhRMA EDC/eSource Taskforce in January 2006. They noted that the regulations do not equate source data with initial data; instead, the discharge summary is considered the source data.