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YouEDC Capture

AND / OR conditions and checks across forms

Show a field, run a check or expect a visit only when conditions on this form, other forms and the patient's card hold.

In registries questions often depend on each other and on other forms: pregnancy is asked of women only, cigarettes of smokers only, a follow-up visit is needed only after surgery. AND / OR conditions are set in the eCRF builder with no formulas and no programming.

Show the field only if · AE form, diabetes registry “Pregnant during the AE?” Show it when all these hold: Patient: sex equals Female the patient's card DX.DM_TYPE · Diabetes type equals 2 — Type 2 the Diagnosis form Holds the field shows; if it is required, the form cannot be completed without it Does not hold the field is hidden and counts as empty: its value is neither saved nor checked A value of another form is the patient's latest saved one, over every visit.

How to write a condition

A condition is rows of “field · how to compare · value” and one switch: all of these (AND) or any of these (OR). Up to eight rows; Add a condition opens the next one.

  • A field of this form: SMOKER, as before.
  • A field of another form: DX.DM_TYPE. The patient's latest saved value counts, over every visit and repeat.
  • The patient's card: PATIENT.SEX, PATIENT.BIRTH_YEAR, PATIENT.ENROLLED_ON, PATIENT.SITE (the site number: a field, a check or a visit only at some sites), PATIENT.ARM (the code of the randomisation arm, empty before the randomisation: see “The randomisation arm and the blinding” below).
  • Comparisons: equals, does not equal, greater than, greater than or equal to, less than, less than or equal to, is filled in, is empty. “Equals” on a multiple-answer field means “this answer is ticked”. Numbers compare as numbers, dates as dates, and the word “today” is today's date.
  • For a field with answer options the value is picked from the list; the answer code is saved.

Where conditions work

Where conditions work · one and the same editor 1 Show a field · field properties PATIENT.SEX=F AND DX.DM_TYPE=2 the field shows only while the condition holds 2 A check · “If - then”, “Only when…” AE_START < VS.VS_DATE, only when VS.SMOKER=1 compare with a field of another form or the patient's card 3 A visit · “Expected only if” PATIENT.SEX=F OR DX.PREG=1 the visit is in the patient's schedule only when it holds

Showing a field. A hidden field counts as empty: its value is not saved, and being required and the checks do not apply to it. One “equals” on a field of the same form is kept as the simple show-if of before; anything else as an AND / OR condition.

An “If - then” check. “Compare with” has the choice another form or the patient: for example, “the AE start date is before the screening visit date” or “the surgery date is before enrolment”. Only when… limits the check to a condition: “HbA1c above 7 %, only when the diabetes type is 2”.

A visit or an event. “Expected only if” now takes several rows too. While the condition does not hold, the visit is not overdue and stays out of the patient's schedule.

A form in a visit only for some patients

A form can be expected in a visit for some patients only: the pregnancy test for women, a substudy form at some sites, the evening-dose check of one arm. Tick the form in the visit on the eCRF page as usual, then open the form and, in the In visits card, set Expected in this visit only if for that visit. The box under the condition tries it at once: type a sex, a site or an answer and see whether the form would be expected. On the eCRF page the cell of such a form shows only if; hover it to read the condition.

While the condition does not hold, the form is not shown in the patient's visit and is not counted anywhere as missing: completeness, the readiness for the database lock, the monitor's and the data manager's counts, the expected-forms widgets, the patient card, the casebook and the visit signature. If all forms of a visit are not expected, the visit itself is not expected. Data entered before the condition stopped holding (the patient's sex corrected, the answer changed) is kept as it is: the form shows in the visit with the mark not expected, data kept, it can be opened and corrected, and every change stays in the audit trail, as with a hidden field.

The randomisation arm and the blinding

PATIENT.ARM is the code of the patient's arm in the randomisation scheme (A, B, …); it is empty until the patient is randomised. In an open-label study it can be used in any condition. In a blinded study it is accepted only in the rules of a form marked “Only for the unblinded team”: the show conditions, checks, actions and conditions in visits of that form. A visit, a form of the blinded team or an action that sends a questionnaire cannot depend on the arm, and saving such a condition is refused with an explanation. For blinded members, for counts and for the patient the arm always reads as empty, so nothing they see depends on it. A form whose rules name the arm keeps its “Only for the unblinded team” mark while they do.

The same conditions everywhere

Conditions work in the browser while the investigator types, on the server when the form is saved, in Excel imports and in ePRO corrections. A form for the patient (ePRO) may name only the patient's other forms and the card: the investigator's data never reaches the patient's browser. Forms of the unblinded team are not offered in the conditions of the blinded team's forms and of visits.

Renaming and deleting

When a field or a form changes its code, the conditions everywhere follow the new code. A deleted field leaves the conditions, and a check comparing with it is deleted with it. A field a visit depends on cannot be deleted until the visit's condition changes. Every change of a condition is written to the audit trail: cond=PATIENT.SEX=F OR VS.SMOKER=1.

Try it before release

The form preview has a box “Other forms and the patient’s card”: type the values in, press “Check as when saving” and see the form as the investigator would for such a patient. In the eCRF in Excel the SHOW_IF column writes the condition as a line, PATIENT.SEX=F AND DX.DM_TYPE=2, and reads it back the same way. The data validation plan (DVP) and the investigator guide describe the condition in words.