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Data Transfer Agreement (DTA) Settings

The DTA panel (Management → DTA) lets study administrators author, version, and export a formal Data Transfer Agreement for a study. The DTA documents exactly what data will be delivered to a sponsor or partner, in what format, and on what schedule.

Exporting a DTA produces a versioned .zip package containing:

  • A Word (.docx) document describing the study, data fields, export format, and delivery terms.
  • Sample CSV files showing the exact column layout recipients will receive.
  • A CHANGELOG.txt summarising what changed since the previous version.

Export contract — what the DTA defines​

The DTA panel is the authoritative source for how reader data will be exported. Every field set here is saved and automatically loaded as the defaults in the Export Data tab (Reader Report type). Recipients of the DTA package receive a document that reflects exactly these settings.

Report format​

Choose the file format recipients will receive:

  • CSV — comma-separated, suitable for most analysis tools.
  • Excel — .xlsx workbook.
  • JSON — structured JSON array for programmatic processing.

Transform type​

Controls how the reader report data is structured:

TransformDescription
RawData as stored, no flattening
TidyWide-format, one row per report
FDA CDISC SDTMCDISC SDTM-compliant column layout

One-hot multiple-choice fields​

Expands every multiple-choice question into one 0/1 column per answer option. This produces a fixed, stable column set regardless of how many options a reader selects — a requirement for a reproducible DTA manifest. Strongly recommended for studies where recipients need a predictable schema.

Group identifier/metadata columns at the front​

Groups all identifier and report metadata columns (subject ID, timepoint, upload ID, reader, consensus flag, etc.) at the front of the file, ahead of the data fields, rather than scattering them alphabetically.

Max occurrences per repeating group​

For forms that include repeating panels or matrix-dynamic sections, this sets the maximum number of occurrences the manifest and sample files will represent. Set this to the largest number of repetitions you expect any reader to complete. Columns beyond this cap are not included in the frozen manifest.

Keep newest reports only​

When enabled, the delivered export includes only the most recent report per unique combination of site, subject, timepoint, upload, and reader. Useful when recipients want one clean row per reading slot rather than the full save history.

Included forms​

By default every active reader (OUTPUT) form is included. Select specific forms to restrict the DTA to a subset. Leave all unchecked to include every form.

DTA document options​

These fields appear in the generated .docx and control what sections are included.

Additional report sections​

  • Subject reports — includes subject-metadata fields and their export instructions in the document.
  • Quality control reports — includes QC-form fields in the document.

Delivery terms​

  • Frequency — how often data will be delivered (e.g. "Monthly", "At study closeout"). Choose from the dropdown or the custom option.
  • Transmission method — how data will be transmitted (e.g. "Direct download from the Brainstorme platform", "Secure FTP"). Choose from the dropdown or the custom option.

Output format​

  • Full package (.zip) — delivers the DTA document, sample data CSVs, and changelog together.
  • DTA document only (.docx) — delivers the Word document only.

Template document​

By default Brainstorme uses its standard DTA Word template. You can supply a custom Google Doc template to apply your organisation's branding or boilerplate.

  1. Share the Google Doc with Anyone with the link can view.
  2. Paste the URL into the Custom Google Doc template field.
  3. Click Save template (or enable Also save template when exporting to save it automatically on your next export).

The following placeholders in the Google Doc are replaced at export time:

PlaceholderReplaced with
{{version}}DTA version number
{{study_name}}Study name
{{date}}Export date
{{appendix}}Data-field appendix tables

To revert to the standard template, select Standard Brainstorme template and click Clear saved custom template.

Version management​

Every time you export a DTA, Brainstorme computes a version number automatically. The version bumps if any of the following have changed since the last export:

  • The set of data fields (forms added, removed, or modified).
  • The DTA document template text.
  • The export configuration (format, transform, one-hot, grouped columns, forms, repeating cap, keep-newest).

If nothing has changed, re-exporting keeps the same version number.

You can override the version number manually in the Version field before exporting. The Changes since v_n_ panel shows exactly what has changed since the last version — data-field additions, removals, modifications, and document text differences.

Saving settings without exporting​

Click Save as study default to persist the current export contract (format, transform, one-hot, grouped columns, repeating cap, keep-newest, included forms) and DTA document options (frequency, transmission method, output, include subject/QC) without generating a full DTA export. The saved values are used as the defaults in the Export Data tab immediately.

Column manifest and drift detection​

When you export a DTA, Brainstorme freezes a column manifest — the exact ordered list of column names that the agreed export configuration would produce. This manifest is stored with the DTA version and included as a column_manifest_*.csv file in the zip package.

After the DTA is exported, if the study's forms change (fields added, renamed, or removed), the Export Data tab will automatically display a warning:

Columns have changed from the DTA manifest (v_n_) — you might need a new DTA version.

This warning is schema-level: it appears as soon as the forms diverge from the frozen manifest, not only after an export is attempted. The changed column names are listed so you can decide whether a new DTA version is warranted.

To clear the warning, export a new DTA with the updated form configuration — this freezes a new manifest that matches the current state.

Workflow summary​

  1. Open Management → DTA for the study.
  2. Set the export contract: report format, transform type, one-hot, grouped columns, repeating cap, keep-newest, and included forms.
  3. Set the DTA document options: output, include subject/QC, frequency, transmission method.
  4. Optionally configure a custom template.
  5. Review the Changes since v_n_ panel.
  6. Click Export DTA to download the versioned package.
  7. The Export Data tab will now load these settings as defaults for any Reader Report export.