Data standards

CDISC ODM and SDTM Export from the EDC

ResearchGuru EDC exports study data in CDISC formats directly from the project: ODM for exchange and archiving, and an SDTM package for analysis and submission work.

Standards are cheapest when they are built in from the first day. We design each eCRF with CDASH-style item codes and controlled answer lists, so the path from collection to a standard dataset is short, and the export sits on the same screen as Excel and CSV.

Discuss your study

Two standard exports

Both are produced from the Export page of the project, by users with export permission, and each export is written to the audit trail.

CDISC ODM

One XML file for exchange and long-term archiving.

  • ODM version 1.3.2
  • Study design: forms, item groups, items and code lists
  • Clinical data for every record
  • The full audit trail for each value
  • Electronic signatures
SDTM package

A zip file for programmers and statisticians.

  • Datasets in SAS transport format (XPT version 5)
  • define.xml version 2.1
  • A conformance report listing what to review
  • Dataset-JSON as an option
  • Mapping saved with the project and reused at every export

Excel, CSV, R, Stata and SPSS exports remain available for everyday analysis.

Why standards early

Decide on the standard before the first record, not after the last

Retrofitting a standard to a finished dataset means renaming variables, recoding answers and explaining every decision. Collecting to the standard avoids most of that work.

Consistent across studies

The same item codes and answer lists from one study to the next, so datasets can be pooled and programs reused.

Ready for partners

Sponsors, CROs and data-sharing platforms increasingly ask for CDISC formats. An export on demand answers the request without a separate project.

A complete archive

At study close, the ODM file keeps the design, the data, the audit trail and the signatures together in an open format.

How mapping works

From CDASH-style collection to SDTM domains

The mapping is proposed automatically and confirmed by a person. Nothing is guessed silently.

Collect with standard codes

Items are named in the CDASH style during the eCRF build, for example BRTHDAT, SEX, AETERM and VSSYSBP, with units and coded answers defined in the specification.

Review the proposed mapping

The mapping page suggests the SDTM domain and variable for each item and lists anything it could not match.

Resolve what is left

Study identifier, country, visit schedule and unmatched terms are set explicitly on the mapping page, and the choices are saved with the project.

Export and check

The package is generated with its define.xml and a conformance report, ready for your own validation tool.

Scope

What the export covers, and what stays with your programmers

The export gives a mapped, documented starting point, produced in minutes at any stage of the study. It is not a substitute for submission programming, and we would rather say so here than in a footnote.

Final SDTM datasets for a submission should be reviewed by a CDISC programmer and validated in the tool your organisation uses.

Tables, figures and listings inside the EDC

Outside the export

  • Dictionary coding, such as MedDRA and WHODrug
  • Trial design domains
  • Values longer than 200 characters, which the XPT version 5 format truncates
  • Validation with your conformance tool before any submission

Frequently asked questions

CDISC export: common questions

Something else? Get in touch and a senior researcher will answer.

No. Many observational and academic studies deliver in Excel, CSV, R or Stata. Building with CDASH-style codes costs nothing extra and keeps the option open.

Yes. It carries the study design, the data, the audit trail and the signatures in one vendor-neutral XML file, which is why many teams keep it as the archive copy at study close.

Yes. The mapping is saved with the project, so a package can be produced at any data cut.

The domains follow the items in your eCRF, for example demographics, vital signs, medical history and adverse events. The mapping page shows the domain and variable proposed for each item before anything is exported.

We prepare it with the eCRF build and review it with your data manager or statistician. Unmatched terms are listed for a decision rather than mapped automatically.

Planning a study that needs CDISC deliverables?

Send us your protocol and data specification. We'll review them and come back to you with:

Start your enquiry

Or email admin@edcstat.com · call +44 7484 816484

  • An initial database-build assessment
  • Any questions or recommendations
  • A proposed delivery schedule
  • A clear scope of work
  • A project quotation

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