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What does direct data entry mean in clinical research?
CDISC’s glossary defines the concept as recording data by human or automated action when an electronic record is the original means of capture and there is no paper source document. In this usage, the key question is not whether data was typed into a computer; it is whether the electronic system created the original record. CDISC glossary
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Human entry
A researcher who observes a result and enters it directly into a study system is making an original electronic record.
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A measuring device, such as a balance or ECG machine, may send its output directly to an electronic-record system. That can also be direct entry because a paper source document was not created first.
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How is direct entry different from transcription?
The distinction is the sequence and status of the records:
| Workflow | What happens | Term in clinical research |
|---|---|---|
| Original electronic capture | An observation is entered into the electronic system, or a device records it there; the electronic record is the source. | Direct entry |
| Paper first, electronic copy later | An observation is recorded on paper and subsequently typed into a database. | Transcription from a paper source |
The distinction can be obscured by broad use of terms such as “data entry” and “electronic data capture.” An archived CDISC glossary describes data entry as human input into a structured computerized format and notes that electronic data capture often refers to manual entry of case-report-form data transcribed from source documents. It separately describes direct entry as original electronic capture. Archived CDISC glossary
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What does direct data entry mean in health-plan transactions?
In health-plan transaction rules, the phrase can describe a different process: data entered through a terminal or web browser and immediately transmitted to a health plan’s computer. That definition focuses on how information is sent, rather than on whether an electronic record is the original source. The definition is attributed to 45 CFR § 162.103. 45 CFR § 162.103
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Examples in a study workflow
- A researcher enters an original observation directly into the study system.
- A balance or ECG machine automatically records a measurement in an electronic-record system.
- A participant or coordinator enters information directly into a REDCap study database. University of Alberta REDCap Support says that in this situation REDCap is considered an electronic source document. University of Alberta REDCap Support
What should study teams document?
Direct electronic capture does not by itself establish that data is accurate. AHRQ’s registry guidance notes that manual key-entry error rates vary with personnel and identifies review and upfront validation checks as relevant controls; it does not provide a single general error-rate figure. AHRQ registry guidance
For a clinical study, specify which record is the source for each data item. University of Alberta guidance recommends documenting source arrangements in study procedures or a site-specific source data guide, since they may differ among sites. University of Alberta REDCap Support
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