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Quick startSign up, create a study, invite the team, open the DM workspace. Two zones: EDC and DM workspaceWhat lives where and how to switch. Your accountProfile, language, password, signing out everywhere.

Creating a studyStudy or DM project; name, code, type, the first site. Study overview and settingsSet-up steps, launch, lock, blinding. Sites and teamSites, investigators, roles, site access, invitations. Audit trailWhat is recorded, how integrity is checked, export.

DM workspaceDM projects and tools for studies in any EDC. DM projectsA study in another system: team, tasks, checklists, status, archive. Data profilerCheck an EDC export: types, gaps, duplicates, outliers. CDISC: SDTM, ADaM, Define-XMLSources, the mapping specification, the build, checks, licences and limits. Check effectivenessHow a query is judged to have changed the data, and how to read the verdicts. Medical codingDictionaries, how terms are matched, your decisions, licences. What changed: compare two exportsNew, removed and changed records between two exports of a listing. Lab normal rangesLoad ranges per site, keep versions, check a lab export against them. Lock readinessChecklist, counters per site and the readiness status before database lock. Export to CDISC ODMWhat ODM is, how the export is read, keys, data types, validation. Protocol to study buildVisits, forms and fields drafted from a protocol's schedule of activities. Comparing protocol versionsWhat an amendment changes in the schedule and in the eCRF. eCRF specification from a protocolWhat the specification contains, how versions work and how to read it back. Query reportAgeing, site response time and query hot spots from a query listing. SAE reconciliationHow events are paired, what is compared and how comments carry over. Data review with marksReview rounds in Excel: marks carry over, changed rows come back. Specification checkWhat the check finds in an eCRF specification and how to read the report. Vendor reconciliationHow samples are paired, what is compared, visit codes and extra columns. Overdue visits and missing pagesWhich listings to upload, how the schedule is written, how due dates are counted. Cross-form checksWhich listings to upload, what each check looks for, the visit schedule.

AdministrationUsers, functions on and off, limits, usage, system jobs. E-mailWhich letters the portal sends and how mail is configured. Security and personal dataPasswords, lockout, sessions, where data is stored.