Source Data Capture

Source Data Capture reads values out of source documents — lab reports, radiology PDFs, scanned notes, screenshots — and suggests them for the matching fields of a participant pathway. Instead of transcribing dozens of values by hand, you upload the documents, review each suggestion next to its field, and apply or dismiss it. No value ever enters the participant record automatically.

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Enabling Source Data Capture

Source Data Capture is off by default and must be turned on per study. A study team member with permission to manage sites enables it under Study > Setup > Site Settings. Active studies must be in amendment to change the setting. See Study Configuration.

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Where It Runs

Open a participant’s pathway (CRF) in edit mode. When Source Data Capture is enabled for the study, site members with write permission see a Source data capture button in the toolbar. The button, the per-field suggestion banners, and the suggestion tags are hidden when:

• You are viewing the pathway read-only
• You lack site write permission
• You hold both study and site roles but are viewing as study team

If the study disables Source Data Capture, you cannot start new extractions. Suggestions that already exist stay visible, so you can still apply or dismiss them. The Source data capture button stays available only when the pathway already has extractions, so you can reach their history and stop a running one.

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Running an Extraction

While an extraction runs, the drawer shows live read x of y progress, the toolbar button shows a spinner, and a Stop extraction button cancels the remaining files. The extraction keeps running if you close the drawer or navigate away.

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Reviewing Suggestions

Each suggestion appears as a banner directly below its field, showing: Collapsed question group headers carry an N AI Suggestions tag, so pending suggestions stay visible while a section is closed.

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Apply

Apply writes the value through the same path as a hand-typed entry: validation, conditional logic, calculated fields, and the normal data-update audit event all behave exactly as if you had typed the value yourself.

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Dismiss

Dismiss removes the suggestion without changing the field. If a later extraction finds the same value again, the suggestion returns collapsed to a single line with a Show link, so re-uploading a document does not spam you with values you already rejected. For a field marked as sensitive, Carelane cannot compare encrypted values. Any new suggestion for a sensitive field returns collapsed if you dismissed a suggestion for that field before. A pending suggestion is also dropped automatically when you edit its field by hand, when the field is hidden by a condition, or when its extraction is deleted. Suggestions are personal and belong to the participant they were extracted for. Only the user who ran the extraction can see them, and only while they still have write permission for the site.

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Sensitive fields

For a field marked as sensitive, Carelane encrypts the suggested value, the source quote, and the reasoning with the site’s key as soon as the extraction finds them. They stay encrypted while the suggestion is pending and after you apply or dismiss it. Carelane decrypts them only to show them in the banner and records the decryption in the audit trail once per participant page. If a sensitive suggestion cannot be decrypted, the banner shows The AI suggestion for this field could not be decrypted. Click Retry to try again, or Dismiss to drop the suggestion.

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Which Fields Get Suggestions

The AI only suggests values for fields a site user fills in by hand. Excluded:

• Fields inside repeating groups
• Read-only and calculated fields
• Score and points fields

Suggestions are validated before they reach you: the answer type must match the field type, choice answers must resolve to one of the field’s own answer options, a quantity whose unit differs from the field’s unit is discarded, and low-confidence candidates are dropped. For a multiple-choice question, the AI suggests every answer option the source document supports. The banner lists all suggested options, and Apply saves all of them. For a single-choice question, a candidate that matches more than one option is ambiguous and is dropped.

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Fields that already have an answer

The AI also reads values for fields that already hold an answer. It never receives the answers in the CRF. Instead, Carelane compares each value the AI finds with the field’s current answer:

• Same value: No suggestion is shown.
• Different value: The suggestion is shown with the Overwrites tag and the current value struck through.

Coded answers, such as choice options, are compared by their code. For multiple-choice questions, Carelane compares the set of selected options, so the order does not matter. Quantity answers are compared by their value. Use this to catch values that were typed incorrectly before you uploaded the source document. Sensitive answers are stored encrypted, so Carelane cannot compare them during extraction. A value found for a sensitive field is always suggested. The banner decides whether to show the Overwrites tag after it decrypts the values.

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Extraction History

The drawer lists recent extractions with their files, status, and suggestion count: Deleting an extraction removes the open suggestions it produced. Values you already applied stay in the participant record, and the entry remains in the history marked as deleted, so the record of what was uploaded survives.

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Privacy and Audit

• Documents are not stored. Uploaded files are transferred encrypted, read once for the extraction, and then discarded — only the file names remain in the history.
• Files are processed in the applicable jurisdiction and are not used to train AI models.
• Applying or dismissing a suggestion writes an audit event that records the target field, the accepted value, the confidence, the reasoning, the source quote, and the source file name — so an applied AI value is always traceable to the document excerpt it came from.
• For sensitive fields, the value, source quote, and reasoning in that audit event are stored encrypted with the site’s key. Carelane takes the recorded value from the stored suggestion, not from your browser.

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Limitations

• Fields inside repeating groups are not supported.
• One suggestion is shown per field; there is no bulk accept-all.
• Suggestions are per-user — deleting an extraction removes only your own open suggestions.

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