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Your first subject: from enrolment to a completed visit

This route is a site coordinator’s main working path, walked once from start to finish on test data: you will enrol a subject, fill in the form of the first visit, correct a value the way it is done in a real study, and answer a query.

What you will have at the end

Section titled “What you will have at the end”
  • The test study has a subject in Screening.
  • The form of the subject’s first visit is Complete.
  • One value has been corrected with a reason for change, and the edit is visible in the field’s history.
  • A data query has moved from Open to Answered.

What you need

Section titled “What you need”
  • You have done Your first 15 minutes in X7 Insight — you know where the rail, the breadcrumbs and Tasks are.
  • The Coordinator role at a site of a test study your administrator gave you. You need the permissions to enrol subjects (subject.create), enter and edit values (data.enter, data.update) and answer queries (query.answer) — the coordinator role template already includes them.
  • The test study’s design is published and the site is active. If the study is in UAT, a strip under the top bar reads “Test contour — all data is test data”, and the subject you create is marked as a test subject and removed before go-live — exactly what you want for practice.
  • For the query step — a colleague with the monitor or data manager role who will open a query on your field (or an edit check in the design that opens one by itself).

Steps

Section titled “Steps”

  1. Enrol a subject. Open the study and click Subjects in the rail, then Add subject. In the “New subject” dialog pick the Study site ID (activation) and leave Subject code empty — it is assigned automatically following the “site code-NNN” pattern. Click Create.

    You should see: “Subject … created” (in UAT — “Test subject … created (removed before go-live)”), and the system opens the new subject’s casebook straight away, in Screening. If you added the subject from the study Overview, the Open casebook → link takes you to the casebook.

  2. Open a visit. The casebook is a matrix whose columns are the scheduled visits and whose rows are forms. The scheduled visits and their forms are already there: the system created them together with the subject. The first unfilled form is highlighted as the “Next form to complete”.

    You should see: the matrix of visits and forms; every form is Not started.

  3. Fill in the form. Click the highlighted cell to open the form. Enter values in order: Enter moves to the next unfilled field. Each value saves itself (“Saves automatically”, then “Saved at …”); every save is written to the audit trail. Initial entry needs no reason.

    You should see: after the first value the form is In progress, and the field is marked Entered.

  4. See how checks work. If the design sets a range for a field, enter an obviously impossible value. A blocking check will not let it save and shows the rule’s message; a query check accepts the value but opens an automatic query on the field. Put back a correct value.

    You should see: the rule’s message at the field — and a sense of which values the system rejects and which it only questions.

  5. Mark the form complete. When the needed fields are filled in, click Mark complete. If required fields are still empty, the system lists them: go to the field or click Complete anyway.

    You should see: “Form marked complete”, and the form is Complete.

  6. Correct a value with a reason. Change any value that is already saved. The “Reason for Change” window opens: Previous value, New value and the Reason list — pick, for example, “Data entry error” — then click Confirm. Cancelling returns the field to its saved value.

    You should see: the new value is saved and the form is back in In progress — the status honestly reflects that the data has changed. Value history… in the field menu shows “before → after”, the author, the time and the reason. Click Mark complete again.

  7. Answer a query. Ask a monitor colleague to open a query on one of your filled-in fields (field menu → Open query…). The query appears in your Tasks on the queries tab; click the row to open the form focused on the field. In the Queries & signatures panel read the question, write an explanation in “Your answer…” and click Send answer. If the question calls for correcting the data, correct the value as in step 6 with the reason “Correction per monitor’s query”.

    You should see: “Answer saved — the query awaits closure by the monitor or data manager”; the query is Answered. The monitor or data manager closes it.

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Entering a value, a blocking check and saving — with an audit trail entry.

What you learned

Section titled “What you learned”
  • A subject is enrolled under a code, with no personal data, and immediately gets the scheduled visits.
  • The casebook points you to the next form, and values save themselves.
  • A form’s status is the entry axis: Not started → In progress → Complete; an edit sends the form back to in progress.
  • Editing a saved value requires a reason, and the previous value stays in the audit trail forever.
  • Answering a query moves it to Answered; someone else closes it.

Next

Section titled “Next”