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Task guides

Last updated Oct 21, 2026

Step-by-step guides for the jobs people actually do, in the order a study needs them. Each one says who can do it, where to find it, what you can do and every option on the screen, what the system records, what you cannot do and why, and answers the compliance questions an inspector would ask about that job. The facts they share (roles, statuses, audit events, errors) are on the reference pages; how to build a form is in The form builder.

Setting up the organization

  1. Set up your organization: the setup wizard: choose roles, invite the team, finish.
  2. Manage organization roles: create, clone, edit and suspend roles, and the guardrails every role passes.
  3. Invite and manage members: invitations and their mail, a second administrator, suspension and removal.
  4. Review organization access and audit: who holds what, access exceptions, and the organization's audit trail.
  5. Manage your settings and sessions: how you sign in, and where you are signed in.

Setting up a study

  1. Create a study: the new-study wizard and the Project Manager.
  2. Build a study: the workbench, settings and the order of work in Setup.
  3. Staff a study team: who is on the team, sponsor staff and what each role may do.
  4. Design forms: draw the eCRFs, or generate a first draft with AI.
  5. Use the form library: reuse forms across studies.
  6. Plan visits: the visit schedule, windows, and which form goes where.
  7. Review and release a study: the version path from Build to Live.
  8. Test a version in UAT: cycles, test participants, issues and the verdict.
  9. Sign off a version and go live: the three signatures and the switch to Live.
  10. Change the state of a study: hold, resume, close to enrollment, complete.

Opening sites

  1. Open a site: register it, clear the ethics gate, activate it.
  2. Staff a site: provision people and get the delegation of authority signed.

Running participants

  1. Screen a participant and record eligibility
  2. Record consent and re-consent
  3. Enroll a participant: consent, screening, eligibility, enrollment.
  4. Run a visit: visit windows, unscheduled visits, early access.
  5. Enter visit data: what happens when you press Save.
  6. Correct data: reasons for change, and why a correction may be refused.
  7. Change a participant's status: completion, withdrawal, lost to follow-up, screen and randomization failure.
  8. Use the casebook: the whole participant record in one place.

Keeping data clean and safe

  1. Work with queries: raise, answer, close, reopen, escalate.
  2. Report a deviation: protocol deviations and their severity.
  3. Monitor and verify data: the SDV plan and the monitor's queue.
  4. Sign records: the investigator signature and what it locks.
  5. Record an adverse event
  6. Review and reconcile a serious adverse event

Seeing and taking data out

  1. Use the reports and the dashboard
  2. View the live design
  3. Review the audit trail
  4. Manage documents: the study and site document register.
  5. Export data: CSV, Excel and CDISC ODM-XML.

Changing and closing

  1. Amend a live study: new versions on a running study.
  2. Correct a design after UAT: rounds, corrections, the amendment and the save history.
  3. Close and lock a study: close-out, two-person lock, archive.