youEDC

Getting started

• Quick start: Sign up, create a study, invite the team, open the DM workspace.
• Two zones: EDC and DM workspace: What lives where and how to switch.
• Your account: Profile, language, password, signing out everywhere.

EDC: running studies

• Creating a study: Study or DM project; name, code, type, the first site.
• Study overview and settings: Set-up steps, launch, lock, blinding.
• Sites and team: Sites, investigators, roles, site access, invitations.
• Audit trail: What is recorded, how integrity is checked, export.

DM workspace

• DM workspace: DM projects and tools for studies in any EDC.
• DM projects: A study in another system: team, tasks, checklists, status, archive.
• Data profiler: Check an EDC export: types, gaps, duplicates, outliers.
• CDISC: SDTM, ADaM, Define-XML: Sources, the mapping specification, the build, checks, licences and limits.
• Check effectiveness: How a query is judged to have changed the data, and how to read the verdicts.
• Medical coding: Dictionaries, how terms are matched, your decisions, licences.
• What changed: compare two exports: New, removed and changed records between two exports of a listing.
• Lab normal ranges: Load ranges per site, keep versions, check a lab export against them.
• Lock readiness: Checklist, counters per site and the readiness status before database lock.
• Export to CDISC ODM: What ODM is, how the export is read, keys, data types, validation.
• Protocol to study build: Visits, forms and fields drafted from a protocol's schedule of activities.
• Comparing protocol versions: What an amendment changes in the schedule and in the eCRF.
• eCRF specification from a protocol: What the specification contains, how versions work and how to read it back.
• Query report: Ageing, site response time and query hot spots from a query listing.
• SAE reconciliation: How events are paired, what is compared and how comments carry over.
• Data review with marks: Review rounds in Excel: marks carry over, changed rows come back.
• Specification check: What the check finds in an eCRF specification and how to read the report.
• Vendor reconciliation: How samples are paired, what is compared, visit codes and extra columns.
• Overdue visits and missing pages: Which listings to upload, how the schedule is written, how due dates are counted.
• Cross-form checks: Which listings to upload, what each check looks for, the visit schedule.

Administration and security

• Administration: Users, functions on and off, limits, usage, system jobs.
• E-mail: Which letters the portal sends and how mail is configured.
• Security and personal data: Passwords, lockout, sessions, where data is stored.