Data management · ExportsUpdated October 13, 2026

A clinical trial data dictionary generator that writes itself

Capture generates the data dictionary and codebook from the forms you built, so every export arrives with the names, types, choices and codes needed to read it. Raw and decoded files, OIDs and SDTM domains included.

  • Built from your eCRFs
  • Raw and decoded files
  • OIDs and SDTM domains

Free sandbox · No credit card · 21 CFR Part 11 aligned

Codebook extract · demo study
TypeChoices / unitDomain
SYSBP · Systolic blood pressureNumbermmHgVS
AESEV · SeveritySingle choice1 Mild · 2 Moderate · 3 SevereAE
SEX · Sex at birthSingle choiceF · MDM
BMI · Body mass indexCalculatedkg/m2VS
CMSTDAT · Start dateDateISO 8601CM
Demo variables. Your dictionary follows the forms in your own study

What to know first

  • Capture builds the data dictionary automatically. It is produced from the forms in the study, not written separately in a spreadsheet that drifts out of date.
  • CSV and Excel exports are wide format, one row per submission, and come with the codebook, as raw and decoded files, with date-range and by-site filtering.
  • Every eCRF template carries an OID and an SDTM domain (for example DM, VS, EG, PE, LB, MH, AE, CM). The SDTM export writes SAS XPT datasets with Define-XML.
  • Because the dictionary comes from the build, it changes when an approved form is amended, and the amendment is a deliberate, recorded step.
  • This page covers the dictionary and codebook. For the SDTM tabulation route see CDISC SDTM export software.

The problem

Why a hand-written data dictionary is the first thing to go wrong

A data dictionary is the document that says what each variable in the dataset means: its name, label, type, allowed values, units and where it came from. A codebook is the same idea aimed at the analyst, usually adding the decoding of numeric codes into words. In practice the two terms overlap, and a statistician who receives an export without either has to reverse-engineer the study from column headings such as Q14_b.

The usual failure is not that nobody writes one. It is that somebody writes one at database design, the protocol is amended twice, a choice list gains a value, a unit changes from mg/dL to mmol/L, and the spreadsheet is never touched again. At analysis the dictionary describes a study that no longer exists. Inspectors and reviewers who ask for it get a document nobody trusts.

Generating the dictionary from the same objects that define the forms removes the second copy. The only source of truth is the form; the dictionary is a view of it. That is the design Capture follows, and it is why this page treats the dictionary as part of the export rather than as a separate deliverable. For the wider data management picture, see clinical data management software and the data management plan template.

How it works

From the form builder to a codebook that travels with the data

You define each question once in the visual builder: its type, choices, unit and rules. When you export, the dictionary and codebook are produced from those same definitions and delivered with the data.

  • Export shape: wide format, one row per submission, as CSV or Excel.
  • Raw file: the stored values and codes, for programmers and for archive.
  • Decoded file: codes shown as their labels, for review and listings.
  • Filters: date range and by-site, so a site-level extract carries the same dictionary.
  • Identifiers: every eCRF template carries an OID and an SDTM domain; the SDTM export gives SAS XPT files with Define-XML.
Export package · demo study

Format

CSV / Excel

Files

Raw + decoded

  • Data file (raw codes)one row per submission
  • Data file (decoded labels)one row per submission
  • Data dictionary / codebookgenerated
  • Filter: Site 003, Jan to Marby-site and date range
  • SDTM datasets and Define-XMLseparate SDTM export
Demo screen. The exact files follow your study and export choices

What a dictionary holds

The fields a useful codebook should contain, and where each comes from

General practice for any study dataset. In Capture these attributes are properties of the form and field you built.

AttributeWhy the analyst needs itWhere it comes from in the build
Variable name and labelReading the dataset without the CRF in handThe question you wrote and its code
TypeImporting dates, numbers and text correctlyNumber, date, single choice, text and the other question types
Choices and codesTurning 1, 2, 3 into Mild, Moderate, SevereThe choice list, shown in the raw and decoded files
Unit and precisionAvoiding mixed-unit analysisUnit and decimal places set on the question
DerivationKnowing a value was computed, not enteredCalculated fields such as BMI, eGFR or QTc, shown read-only at entry
Form and visitPlacing the value in the protocol scheduleThe form and visit the field sits on
OID and SDTM domainLinking to standards and submission datasetsCarried by every eCRF template

Which attributes appear in each exported file is confirmed by exporting a test study in the free sandbox.

Export a codebook from a test study

Build two forms in the free sandbox, enter sample data and download the export. No credit card and no time limit; you pay only once you go live with real participants.

See a codebook in the free sandbox

Staying correct

Keeping the dictionary right when the protocol changes

Forms in Capture move through a draft to approved lifecycle, and approved forms are locked for live use. That matters for the dictionary: a variable cannot quietly change meaning in the middle of a study, because changing it is an amendment, not an edit. When an amendment is made, the next export reflects it, and the amendment history sits alongside the data in the same audit trail. See CRF builder for clinical trials.

Plan the dictionary review as a fixed step before database lock. A practical order is: export the codebook from the test data, read it against the protocol and the statistical analysis plan, resolve every variable the analyst could misread, then freeze it. The database lock and unlock workflow page covers what follows. Teams exporting for statistical software will also find exporting EDC data to R, SAS and SPSS useful.

If you are migrating from a spreadsheet or another system, write down the mapping from your old column names to the new variable names and keep it with the archived export. Capture does not claim an import tool on this page, so treat the mapping as documentation for the analysis, not as an automated step.

Dictionary review before lock · demo
  1. Test data entered in sandbox

  2. Codebook exported

    Raw and decoded files

  3. 3

    Read against protocol and SAP

    Names, units, choices

  4. 4

    Fix ambiguous labels

    Amend draft forms only

  5. 5

    Approve and go live

    Approved forms are locked

Demo workflow. Your own review steps belong in the data management plan

Review checklist

Six checks a data manager can run on any codebook

Useful for Capture and for any other system you are evaluating.

Does every exported column appear in the dictionary?

Count columns in the data file and rows in the dictionary; they should match.

Are choice codes decoded somewhere?

Look for a decoded file or a value-label table, not only numeric codes.

Are units explicit?

No numeric variable should leave its unit to be guessed; check labs and vitals first.

Are derived fields marked?

Analysts should be able to tell entered from calculated values.

Does it follow amendments?

Amend a draft form and re-export; the dictionary should change with it.

Can a site extract carry it?

Filter by site and date range and confirm the dictionary comes with the filtered file.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Does Capture generate a data dictionary automatically?

Yes. The data dictionary or codebook is produced automatically with the CSV and Excel exports, built from the forms in your study.

What is the difference between a data dictionary and a codebook?

The terms overlap. A data dictionary describes variables (name, type, allowed values, units). A codebook usually adds the decoding of numeric codes into labels for the analyst. Capture delivers raw and decoded files so both uses are covered.

What export formats are available?

CSV and Excel in wide format with one row per submission, with date-range and by-site filtering. SDTM datasets are available as SAS XPT files with Define-XML.

Do the forms carry CDISC identifiers?

Every eCRF template carries an OID and an SDTM domain, for example DM, VS, EG, PE, LB, MH, AE and CM.

Does the dictionary change if I amend a form?

The dictionary is generated from the forms, so it follows the approved build. Amendments are deliberate: forms move from draft to approved and approved forms are locked for live use.

Can I import an existing dictionary?

This page does not claim an import tool. Build the forms in the visual builder, or let the AI draft them from a file for your review, and keep your old mapping as documentation.

Is this suitable for Phase 1, 2 and 3?

Yes. Capture is suitable for Phase 1, 2 and 3 studies, and the export works the same way at any phase.

How do I try it?

Open the free sandbox, build a form, enter sample data and export. It has every feature, no credit card and no time limit.

Generate your codebook from a real form

Free sandbox, every feature, no credit card. Export it and read it as your statistician would.

See a codebook in the free sandbox