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Direct data entry is the capture of information straight into an electronic system, where the electronic record is the original record rather than a copy of information first written on paper. In clinical research, a person can enter the observation directly, or a device can record its output automatically.
What direct data entry means in clinical research
The CDISC glossary defines “direct entry” 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. CDISC glossary
The defining question is not whether someone typed the data. It is where the original record was made. When a study team member enters an observation directly into an electronic study system, that system can be the source record. When the observation was first recorded on paper and later typed into a system, the electronic version is a transcription.
Direct entry versus transcription
| Workflow | Where the original record is made | How to describe the electronic record |
|---|---|---|
| A researcher enters a new observation directly into an electronic study system | In the electronic system | Direct entry; the electronic record is the original source |
| A clinician records an observation on paper, then someone types it into a database | On the paper document | Transcription from a paper source |
| A measuring device sends its reading directly to an electronic record system | In the electronic system | Automated direct entry |
Terminology can vary by context. An archived CDISC glossary describes “data entry” as human input into a structured computerized format and notes that electronic data capture often refers to manually entering case-report-form data transcribed from source documents. It distinguishes that from direct entry, in which the electronic record is the original capture. Archived CDISC glossary
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Examples of direct data entry
- A researcher keys an original observation into a study system without first writing it on paper.
- A balance or ECG machine automatically records its output into an electronic-record system.
- A participant or coordinator enters study data directly into a REDCap database. University of Alberta REDCap Support says REDCap is considered an electronic source document in this situation. University of Alberta REDCap Support
Direct entry also has a health-plan transaction meaning
Outside clinical research, “direct data entry” can describe a health-plan transaction workflow: data are entered through a terminal or web browser and transmitted immediately to a health plan’s computer. That transmission-focused meaning is attributed to the definition in 45 CFR § 162.103; it is not the same as the clinical-research definition centered on whether an electronic record is the original source. 45 CFR § 162.103
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What direct entry does—and does not—guarantee about data quality
Capturing data directly in an electronic system does not, by itself, ensure that the data are correct. AHRQ’s registry guidance says manual key-entry error rates vary with personnel and identifies review and upfront validation checks as relevant controls; it does not give 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 REDCap Support recommends documenting source arrangements in study procedures or a site-specific source data guide, since arrangements may differ across sites. University of Alberta REDCap Support
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