YouEDC Capture

Entering data into a form

Draft or complete, edit checks, “no data”, the reason for a change, the history of a value.

A form opens from the patient card. Values are checked while you type, the form is saved as a draft or as complete, and every change of a saved value keeps its reason and author.

A form goes from draft to complete, then the monitor marks it as verified (SDV). Changing a value in a verified form removes the mark.

Draft or Save and send for review

Save draft when not all the data is at hand: required fields may stay empty, and the form stays open. Save and send for review when everything is entered: the required fields and all the edit checks are checked, the form becomes complete and goes to the monitor for SDV and to the data manager for approval. Saving a complete form again keeps it complete. In a study without SDV this button reads “Form complete”; a study can give it its own label (see the help article “eCRF builder”, section “Data entry: the save button”).

After saving, the next form of the same visit opens at once, without going back to the patient card. Forms the patient fills in (ePRO) are skipped. After the last form of the visit, the patient card opens at the next visit. If saving opened an automatic query (a value outside the expected range), the form stays on the screen so you can see which field the query is on. A draft and a save with an error also keep you on the form. It works the same on a phone.

The bottom of the Vital signs form: the Save draft and Save and send for review buttons, with a pencil to rename — The bottom of a form: the main button “Save and send for review”. Only the study manager sees the pencil next to it: it leads to the label setting.

After saving the vital signs, the next form of the Screening visit opened: HbA1c, glucose and lipids — After saving the vital signs, the next screening form opened at once: HbA1c, glucose and lipids.

Edit checks

Messages appear under a field as soon as you type, before saving:

red: an error, such as a value outside the allowed range or a date in the future. The form cannot be saved until it is corrected;
amber: an unusual value, outside the expected range. The form can be saved, and an automatic query opens for the monitor.

The counter at the bottom of the form shows how many errors and warnings there are.

No data

If a value is not in the source documents, do not leave the field empty: in No data? next to it, choose Not done, Unknown or Not applicable (when the field allows it). Then the monitor does not need to ask why the field is empty.

Why there is no data. Under the mark, Why? says why the value is missing: Not measured in routine practice, Measured, not in the medical record, The patient refused, Not applicable or Unknown. It is optional and is saved with the value: the audit trail and the value history show it (“ND · Not done · Not measured in routine practice”), and changing it after a save asks for the reason of the change, like any value. In real-world data a value is measured when a physician needs it, so the statistician needs to know whether a gap is random: the reason goes to the export and to the data quality report.

Reason for a change and history

When you change a value saved before, the form asks for the reason: choose one from the list (Transcription error from the source document, Clarified from the source document, Answer to the monitor's query, New data received) or write your own. The old and new values, the author, the time and the reason go into the history of the form and into the audit trail.

The History tab next to the form lists every change. Click the code of a field, for example WEIGHT, to see the history of that value only.

Protocol deviations. In a study with YouEDC Trials, a field with a recorded deviation shows a small marker “Deviation N” next to its label (red for an important one, grey once closed); it leads to the entry of the deviations log. The Protocol deviations card next to the queries lists the deviations of this form and, for those who record deviations, records a new one at a field. Markers and the card are shown to those who see the deviations log, at their sites only. More in YouEDC Trials.

A note on a field. When a value needs an explanation but there is no question for the site, write a note on the Notes tab next to the queries: for example, “the patient fasted only 6 hours”. The note shows under the field to everyone who opens the form, and nobody has to answer it. More in Notes on fields.

Tables

A table in a form is filled in as a grid: Tab moves to the next cell. In a lab panel the unit and the expected range of the row stand next to the result; a result outside the range is highlighted and opens a query on that cell, and a value outside the allowed range is not saved. If a test was not done, choose ND in its cell.

In a growing table the Add a row button adds a row. A new row left empty is dropped when the form is saved. The bin icon marks a saved row for deletion: the row is struck through, and saving then needs a reason. A deleted row does not vanish: its values, the reason and who deleted it stay in the audit trail and in the list of deleted rows under the table, and its number is never given again.

When the study has lab normal ranges loaded, the result shows the normal range of the patient's site for their sex and age, already in the row's unit, and a result outside it is flagged L or H. Calculated rows, such as eGFR, fill in by themselves when the form is saved: nobody types them.

Change since the previous visit. Under a result the table shows the patient's result at the previous visit, for example “before: 90 · Screening”. If the builder set a limit for the row (“Change, max”, such as 50 % for creatinine), a bigger change opens a query on the cell when the form is saved: “Creatinine: 90 µmol/L at Screening, now 150 µmol/L (+67%): more than 50% since the previous visit. Confirm or correct it.” Correct the value if it was mistyped, and the query closes by itself; if the result is real, answer the query.

Paste from Excel. Copy cells in Excel (or a table of a laboratory's report) and press Ctrl+V in a cell of the table: the values fill it to the right and down, and a growing table adds the rows it needs. In a lab table, lines “test, result” go to the rows of the same name or code wherever the cursor is; a test the table does not have is named under the table. Pasted values are checked like typed ones: look them over before saving.

On a phone each row of a table is a card, with no sideways scrolling, so a value never lands in another row.

A lab panel during data entry: creatinine above the expected range, a query is open; AST is marked ND.

The same panel on a phone: each row is a card.

Example from the demo

Anna Petrova, investigator at site 01, fills in the Vital signs form of REGDIA-01-0005 at Month 3 and types a systolic pressure of 172 mmHg. The expected range is 90 to 160, so an amber message appears at once: “Outside the expected range (from 90 to 160 mmHg). You can save: a query will be opened.” The red line on the left marks a critical field, which the monitor verifies first.

An amber warning under the systolic pressure field — A warning while typing: the form can be saved, and a query will be opened.

In the Month 3 Vital signs of REGDIA-01-0004 she notices that the weight was copied as 140 kg instead of 104 kg. She corrects it and gives the reason “Transcription error from the source document”. The history of the WEIGHT value shows both records.

The history of the weight value — The history of one value: the first entry and the correction with its reason.