Notes on fields

Explain a value without a query: who writes notes, where they show, how a note is withdrawn, the export and the casebook.

A note on a field explains a value without a query. The site, the monitor or the data manager writes why the value is what it is, and nobody has to answer. For example: “the patient fasted only 6 hours”, “blood pressure measured after exercise”, “the value confirmed by phone with the lab”. Many queries are raised only to get such an explanation: a note gives it beforehand.

What a note does

• A note belongs to a field of a saved form or to a cell of a table (its row and column).
• It changes nothing: not the value, not the SDV mark, not the data manager's approval, not the investigator's signature.
• Everyone who opens the form sees its notes. Forms hidden by blinding stay hidden with their notes.
• A note can be written on a locked form and during the soft lock of the study. After the database lock no new notes are written.
• The investigator and the site team, the monitor, the data manager and the project administrator write notes.

Write a note

1. Open a saved form of a patient.
2. On the right, next to the queries, open the Notes tab.
3. Choose the field or the cell of a table, write the text and press Save the note.

The note shows under the field as an amber strip with its author, their role and the time, and the field's label gets the mark “1 note”.

A site's note under the field and the Notes tab with the form for a new note.

A note or a query

A query is for a value someone has to check or correct: it is answered and closed. A note is for a value that is right but would raise a question without an explanation. If the note is not enough, the monitor raises a query as usual.

Withdraw a note

A note is never edited or deleted. When the explanation no longer holds, its author withdraws it on the Notes tab: writes the reason and presses Withdraw. A withdrawn note stays on the tab struck through, with the reason, and leaves the field. A new explanation is a new note. Only the author withdraws a note.

Audit trail, export and casebook

• Every note and every withdrawal is a record in the form's audit trail: who, when, which field, the text and the reason.
• The study export gets the Notes sheet (notes.csv in the CSV zip) as soon as the study has a note. It has the patient, the site, the visit, the form, the field, the text, the author and their role, the time, and for a withdrawn note the time and reason of the withdrawal.
• The casebook (PDF/A) shows the notes under the form, and the embedded casebook.json keeps them in the form's data.