Improving Efficiencies in Data Collection: Electronic Source

Clinical Trials

Introduction to Source Documentation

Source documentation is the initial documentation of clinical trial data, regardless of format or location. Typical examples of source documentation include medical records, lab results, and case report forms. Once source data are collected, the data can be transferred to the electronic data capture (EDC) system via manual entry or directly uploaded from the electronic medical record. Manual entry requires verification the source data was accurately entered followed by correction of any transcription or copy errors. Direct upload from medical records or lab reports requires extensive verification and application programming interface (API) modules for EDCs can be expensive. This process makes data collection in clinical trials less efficient by adding additional data transfers and source data verification.

An alternative method of data collection is to input source data directly in the electronic system (eSource or direct data capture). FDA guidance “Electronic Source Data in Clinical Investigations” outlines considerations for the capture, review, and retention of eSource data. Studies can use a mix of both approaches to maximize efficiencies in site and sponsor data processing.

Advantages of eSource

For the site, eSource can significantly reduce data entry time by eliminating  the need to transcribe information from source documentation into the EDC. For the monitor, source data verification is faster when eSource is used as the primary method of data collection. In addition to these role-specific benefits, eSource also minimizes the risk of transcription errors during data transfer, resulting in time savings for both the site and monitor and better data quality.

eSource allows for real-time data collection during patient visits. Data can then be readily monitored and assessed for safety concerns. Automated edit checks can display data entry tips if there are any incomplete, inconsistent, or unreasonable entries so that these can be corrected while the patient is still on-site.

Challenges of eSource

Direct data capture in the EDC requires access to the EDC at the time of data collection. However, there is a growing number of EDCs that are compatible with tablets or phones for better portability and offer offline modes so that data can be entered and saved without needing a stable internet connection.

Storage and retention of the eSource is more involved than locking papers in a filing cabinet. Back-ups should occur regularly to ensure that data are not lost. Data and associated meta-data such as audit trails and access logs should be retained together.

Conclusion

Direct data capture of source data in the EDC (eSource) can greatly improve efficiencies at the site level in data entry and at the sponsor level in monitoring.

Wondering how to include eSource in your study? MED offers a variety of clinical trial services and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us today to start your project discussion!

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