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edc-core is used by people with very different jobs: coordinators keying visits at a site, data managers building and cleaning studies, monitors verifying data, and the people accountable for all of it. The guide pages serve all of them, but nobody needs to read everything. Pick the track that matches your role and read in order; each step says why it comes next.

Every track names a demo persona (demo-coord, demo-dm, demo-inv, demo-cra, demo-admin). If you install the local stack and seed the demo study, you can sign in as that persona and do each step yourself rather than just reading about it.

New to EDC (entry-level data managers)

If terms like eCRF, edit check, and SDV are new, start with vocabulary and a guided loop before any reference material. Follow along as demo-coord for entry and demo-dm for review.

  1. Glossary: skim it once so the rest of the guide reads without stopping to look things up.
  2. Five-minute tour: the whole lifecycle (enter → query → verify → sign → snapshot → analyze) in one sitting, switching personas at each step.
  3. Data capture: the subject matrix, entering values, corrections with reasons, and what the form does on its own (skips, computed fields, repeating groups).
  4. Review workflows: where queries come from, who answers them, and what verification and signature mean.
  5. Medical coding: why “asprin 81mg” needs a dictionary term, and the queue where that happens.
  6. Analytics workbench: the SQL section is enough to answer “how clean is my study today” yourself.

Study builders (advanced data managers)

You already run studies; this track is about building them in edc-core: versioned ODM builds, rules, and what happens after go-live. Work as demo-dm or demo-admin.

  1. Study builds: the versioned, immutable build model everything else renders from, and the three ways to author one.
  2. Rules and derivations: edit checks, skip logic, and computed values, with a JSONata primer.
  3. Why protocol-first? and Protocol import: deriving a build from a USDM protocol package instead of hand-built forms.
  4. Mid-study amendments: diff, impact analysis, and audited migration once the protocol changes under live data.
  5. Site form layouts: letting sites adapt form presentation while you keep one data shape across the study.
  6. Lab data import and RTSM integration: external data through the same audited write path as typed entry.
  7. Blinding: item-level masking, who sees what, and the break-the-blind record.
  8. Analytics workbench and Exports and the study archive: snapshots, R and Python against them, and every path data takes out.

CRO and sponsor leadership

You are deciding whether to trust a study to this system. This track covers the compliance posture, oversight evidence, and exit paths; none of it requires touching a form.

  1. Why edc-core: the licensing and architecture position in five paragraphs.
  2. Compliance: how the system maps to 21 CFR Part 11 and ICH E6(R3), what the validation pack contains, and what remains your organization’s responsibility.
  3. Data lifecycle: the ICH E6(R3) data lifecycle elements, one by one, with how each is handled.
  4. User administration: account lifecycle, per-study role grants, the access log, and security anomaly review, which is the access-control story an auditor will ask about.
  5. Exports and the study archive: the exit path, because your data outliving the system is part of the decision.
  6. Deployment: what running this in production actually involves, whether or not you operate it yourself.

Clinical operations and site staff

Your world is subjects, visits, and queries. This track stays on the site-facing surfaces. Follow along as demo-coord (coordinator) and demo-inv (investigator).

  1. Five-minute tour: the fastest way to see what sites, monitors, and data management each do in the system.
  2. Data capture: the subject matrix, subject lifecycle (screening, enrolled, withdrawn, reinstated), entry, and corrections.
  3. Site form layouts: reorganizing a visit’s forms around your clinic’s flow without changing what the study collects.
  4. Review workflows: answering queries, what the monitor is doing when a form shows verified, and what signing commits you to.
  5. Notifications: how query and signature work finds you instead of waiting on a dashboard.
  6. Blinding: why some staff see the arm while others see a masked field, and what breaking the blind records.

If none of these fit, the user guide sidebar lists every page by topic, and the glossary covers the vocabulary.