Data manager

The data manager owns the study database: builds the design (forms, edit checks, visit schedule) or takes it through review, publishes the version, runs data cleaning and queries, locks data and makes exports. A separate study builder may assemble the design — those tasks are here too. A version is approved and published by someone other than its builder — see segregation of duties.

Your day: frequent tasks

• Build forms in the CRF builderHow to build the draft's forms in the CRF builder: forms, sections, fields and codelists, form logic, the Problems panel and the preview before review.
• Export the audit trailExport the audit trail of a study, site or subject as a file — XLSX to read, PDF to print or CSV for independent verification — with the screen's current filters.
• Manage queriesOpen a data query, accept or reject an answer, reopen or cancel a query, work the queue in bulk, assign an owner and export the register.
• Set up edit checksHow to add an edit check to a form: a condition in the visual builder or as a formula, a message for the site, and the behaviour — raise a query or block entry.
• Publish a version and launch the studyHow to take a design version through the pipeline from build to publication with segregation of duties, add a site and open enrollment — with or without a test run (UAT).
• Lock the dataClose the database with the wizard: close collection, clean the data, apply a soft and a hard lock, build the final package, issue site copies and archive the study.
• Export dataRun an export on the Exports screen — CDISC ODM 1.3.2, CDISC tabular datasets or a core snapshot — and download the file with its SHA-256 checksum.

More tasks

• Create a studyHow to set up a new study: manually, from a template or from a JSON package; what appears right after creation, and how to delete a draft you no longer need.
• Track monitoring progressRead the Monitoring summary by site, export the verification report and record an audit trail review.
• Set up skip logic and derivationsHow to show a field or section only for the right answer (a display condition) and how to make a field computed from other fields (a derivation).
• Build the visit scheduleHow to set up visits with a type and a window in the SoA matrix, assign the schedule anchor, and mark which forms are collected at which visit.
• Add sitesActivate a site on a published design version, close and reopen it, move it to another version.
• Import a study design from a filePrepare a study design in a file from a template, validate it without changes and import it — as a new study or into a version draft.
• Run a protocol amendmentMove subjects to a new published design version with a migration plan: a diff of changes by class, a dry-run with no changes, audited execution.

Good to know

• The CRF path — eight steps and where each button is.
• Lifecycles and status axes — versions, studies, locks.
• Documents and certified copies — which documents the system assembles.