DocsRun a studyExports and CDISC

Exports and CDISC

Export de-identified study datasets, trial-of-record data, and CDISC-oriented output.

TrialPilot has two export paths, matched to two jobs. The Export Study action on the study dashboard produces de-identified datasets for your own analysis — survey responses, assessment results, wearable summaries, the roster, the audit trail. The Data management workspace produces trial-of-record output for studies run to that standard, including CDISC-oriented datasets a statistician or a submission pipeline can consume.

Both paths share one property: everything they produce is de-identified. Participants appear as study-scoped pseudonymous IDs, never as names or contact details — see Privacy and de-identification for how that separation works.

Export study data#

Select Export Study from the study dashboard and choose:

  • Data type — which dataset to export (see the table below).
  • Format — CSV (loads directly into Excel, R, or Stata), newline-delimited JSON, or a single JSON array.
  • Start and end date — an optional time window. Leave the dates empty to export the full study window.
  • Wide format — when the data type supports it, one row per participant per day with measures as columns, instead of one row per data point.

The export downloads as a zip containing the data file and a manifest describing what was produced.

Data typeWhat it contains
Patient-reported outcomesDaily and periodic survey responses.
Objective assessmentsResults from guided physical assessments such as the six-minute walk, sit-to-stand, NASA lean, and timed up-and-go tests.
Wearable summariesDaily aggregate wearable metrics per participant.
Participant rosterEnrollment status and metadata, keyed by pseudonymous ID.
Audit logThe Part 11 style trail of clinical data changes. Available to roles with audit-export permission.

The export tells you what it left out

An export is only trustworthy if you know it is complete. The export dialog shows an inspection summary — row counts per included dataset and stated reasons for anything withheld — so an auditor never has to guess what a file does not contain.

Trial-of-record and CDISC output#

For studies using the Data management workspace, the Export tab there produces CDISC-oriented output. CDISC is the standards body whose formats regulators and statisticians expect clinical trial data in; SDTM is its standard layout for collected study data.

A CDISC export is always tied to a specific database lock or snapshot, which makes it reproducible: the same lock always yields the same export. It produces:

  • SDTM-aligned domain datasets — demographics, vital signs, adverse events, concomitant medications, and questionnaire domains, with adverse events and medications carrying their MedDRA and WHODrug coding.
  • define.xml — the machine-readable data definition file that describes each dataset and its variables, so a receiving system knows how to interpret the export.
  • A statistician-loadable CSV bundle — the same domains as plain per-domain CSV files.

Availability of trial-of-record output depends on your study configuration — a study that never uses the data-management workflow exports through the study dashboard path only.

Test data never leaks into a real export#

Exports respect the sandbox boundary described in Test mode:

  • A draft study's export is always the watermarked sandbox export. The filename is prefixed SANDBOX_, the first line of the data file carries a notice, and the manifest is flagged as test data — so a rehearsal dataset can never pass as a real one.
  • A published study's export excludes test data entirely. The only way to see the sandbox record after publication is to explicitly request it, and then only during its retention window — and what you get is still the watermarked sandbox export.

The retention window is finite

Test data is purged 90 days after publication. If you need a durable record of the rehearsal, export the sandbox record before the window closes.

A typical end-of-study export#

  1. Resolve open queries and finish coding in Data management.
  2. Take the controlled lock — see Locking and closeout.
  3. Generate the CDISC export from that lock for the statistician or submission, and any dashboard exports your own analysis needs.
  4. Archive the downloaded files with your study records.