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.
The duplication of tasks, generation of paper, and associated costs and inefficiencies will only grow as clinics and hospitals
adopt electronic data sources. This increasing burden is worrisome; if not controlled, it could compromise the quality of
execution for both clinical trials and patient care. Small wonder that for many professionals, today's transitional environment
feels like a step backward.
Not as Easy as It Looks
In many ways, the core challenge of integrating EHRs and clinical research—creating an EHR/CR system—is that of creating an
electronic source record, or eSource, that fulfills the needs of caregivers and researchers while staying within regulatory
requirements. Many regulations governing the use of source data (see "eSource: Rules & Regs"). However, these regulations
fail to qualify EMRs and EHRs as eSource. If clinical trial investigators want to use EHRs as eSource for clinical trials,
they need to tackle a number of issues.
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
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.