eSource is a topic that has everyone talking and it continues to dominate the conversation at industry gatherings, including the annual SCDM conference held earlier this fall. From what I heard there − and continue to hear – sponsors' experience with eSource runs the full gamut.
We have trendsetters and trend followers. And like with most new things, we still have our fair share of folks reluctant to try ANYTHING new until the risks, whether perceived or real, are completely vanquished. To help nudge those in the latter group and re-assure those already out front, let me share what we're seeing here at BioClinica regarding sponsors' use of eSource.
We are surrounded here every day by many terrific examples of eSource trendsetters. This group includes the fearless sponsors who were among the very first to go 100 percent eSource. In some of these research programs, eSource is all they know!
We even have sponsors who have directly entered all of their study data into their Electronic Data Capture (EDC) system since 2005! These organizations have quite a track record and say they have no plans of introducing anything that's NOT eSource.
The 100 percent eSource approach works especially well where studies are conducted in clinics dedicated solely to clinical research. In this setting, collecting and archiving patient data in a paper format is unnecessary. Without an electronic medical record (EMR) involved in these studies, all data is entered in a single, centralized location.
One notch below the trendsetters we have organizations that are on-trend with eSource. This group includes sponsors who are collecting select clinical research findings directly in their EDC system. For instance, some are using eSource for certain assessments like the Hamilton Anxiety Rating Scale (HAM-A), which requires an investigator to ask certain questions or conduct an in-person assessment. Subject information is entered directly into the EDC system, eliminating the need to transcribe data from a paper source.
Getting On-Trend Using a Data Hybrid
For on-trend wannabes, BioClinica currently recommends entering data directly into the EDC system (eSource!) when it makes sense and when data quality is improved.
It usually makes sense to collect items such as investigator rating scales directly in the EDC system, eliminating paper source. Any other data already being collected electronically would be merged with the EDC data. Typically, items such as demography data would continue to be collected elsewhere and then transcribed. Taking this kind of hybrid approach allows a site to pull data electronically when it makes sense, eliminating paper source in numerous situations. With eSource, one thing is for sure: it is NOT a short-lived trend. The US FDA strongly supports collecting data directly into the EDC system as shared in this recent video series and recent guidance.
By taking steps to eliminate paper-based collection wherever possible, we can improve the quality of data – a goal that's easy to get behind for anyone working in clinical research.
Got eSource Data?
BioClinica is seeing study data being collected in a variety of exciting new ways and from a growing number of sources – and rapid introduction of new ones shows no sign of slowing down!
The type of data being collected tends to fall into one of seven different categories. See whether or not the data you're collecting is considered eSource in the chart below.
Is It eSource Data or Not?
Patient medical history, demography data, and other information from the medical chart.
May include central lab data or central ECG findings sent to data managers for inclusion in the EDC system or externally reviewed and reconciled from the EDC system.
Data Unique to Study
May include efficacy parameters, such as scales for pain, quality of life, or other areas related to a study's indication. Data can be collected in another method first, such as paper-based questionnaires. It may be from an electronic source such as a polysomnography (PSG) machine where some such data is entered directly into the EDC system.
eSource or non-eSource if transcribed from paper
May include status and prompt questions used in the data cleaning process, not safety and efficacy data. This data is not found in the patient chart or elsewhere.
possibly eSource, i.e. if used to confirm data, missing or otherwise
May include adverse event or concomitant medications typically found in a patient chart, usually with additional information, i.e., severity or relationship; required on the CRF but not typically found in the chart.
eSource & non-eSource combined
Drug Accountability or Exposure Data
May be pulled from an IRT/IWR system for use in analysis.
Vital Sign & Physical Exam Data
Depending on site type this may be collected in the patient chart or electronically. Such data usually ends up being transcribed into the CRF because it needs some type of review before entering it. E.g. the protocol may indicate vital sign taken prior to dosing to be used. This requires the study coordinator to determine which vitals in the chart are appropriate. As for physical exam data, typically only relevant medical history is pulled or information about ongoing conditions reported as adverse events.
eSource or non-eSource if transcribed from paper
With some of the sources cited in the accompanying chart it would be challenging to collect the data using EDC. As illustrated here, the data is coming from a variety of sources. Sometimes things veer off the intended path and go beyond the control of a sponsor. Such is the case when site coordinators continue to use paper as source even though the sponsor has indicated electronic source. This introduces an entirely different challenge, requiring clinical monitors to determine whether or not the correct process was followed.
So are you a trendsetter, a trend follower, or still afraid to dip a toe in the water like mentioned in my last Trial Blazer blog post? Drop me a line and let's keep the conversation going.