Build a form: a walkthrough

What this is, and who it is for#

One Vital Signs form, built from an empty page to a form that is active and bound to visits. The choices are examples: your protocol decides the fields, the limits and which problems should block a save. You need form.design or study.write, and a study with a version in Build. Each step points to the page that has all the options.

Where to find it#

Study → Build → Forms. If the study has no version in Build the page says so and you cannot change forms: start an amendment, or ask your project manager.

What you can do#

1. Create the form#

1. On the Forms list choose New form. The dialog is New form in this study.
2. Code VS (capitals; unique in the study), CDISC domain tag VS (a grouping label only), Display name Vital Signs, Category Assessments, and a Description such as Vital signs at each visit.
3. Choose Create & open builder. The builder opens on an empty form: Start building your form (Overview).

1

Enlarge

1. Creates the form as a draft and opens the builder.

2. Add the visit date#

1. In the toolbox choose Date (group Date & Time). It lands at the end of the form and is selected.
2. Basic tab: Label Date of measurement, Variable name VSDTC.
3. Validation tab: switch Required on; switch Allow future dates off. Under When a check fails the list now shows No future dates; set it to Block: a date in the future should not be saved (Validation, edit checks and their severities).

3. Add the blood pressure#

1. Choose Number twice. First: label Systolic blood pressure, variable SYSBP. Second: Diastolic blood pressure, DIABP.
2. CDMS tab of each: Unit label mmHg, Unit code MMHG; CDASH / CDISC annotation VSORRES is optional (Field properties).
3. Validation tab of each: Min value 40 and Max value 300 (a value outside is not physically possible). Set the Minimum and Maximum checks to Block.
4. Still on Validation, under Normal range, leave One range for everyone and type Normal min 90, Normal max 140 for the systolic (and 60 to 90 for the diastolic). Leave the check at Query: a reading outside it is saved and a data manager is asked to confirm (Units and normal ranges).

4. Add weight, height and a calculated BMI#

1. Add Number fields Weight (WEIGHT, unit kg) and Height (HEIGHT, unit cm), with minimum and maximum to suit.
2. Add a Number Body mass index (BMI), unit kg/m2. On its Logic tab, under Calculation formula, choose Set formula.
3. In the Formula Builder type WEIGHT / (HEIGHT / 100) ^ 2 (or choose the BMI recipe), type sample values under the test inputs (70 and 175 give 22.9) and set Decimal precision to 1. Choose Apply formula. The field now shows Calculated to people entering data and is read-only (Formulas and calculations).

5. Add a choice with "Other"#

1. Add a Radio Position, variable POSITION. On Basic the options start as Option A and Option B: rename them Sitting and Supine (values SITTING, SUPINE), choose Add option for Standing, and switch Other, specify on. On Style choose Horizontal for Options layout (Field types).

6. Show a field only when it matters#

1. Add a Toggle Vital signs taken?, variable TAKEN.
2. Add a Text Reason not taken, variable NOTTAKEN. On its Logic tab choose Add visibility condition, then Add condition: field Vital signs taken?, operator equals, value No; Apply logic. Type a Message when hidden if you want one (Conditional logic).
3. Drag the toggle to the top of the form and add a Section called Measurements, dragging the number fields into it (Sections, headings and layout).

Enlarge

7. Look for problems and try it#

1. If the toolbar shows red or amber counts, open them. Fix each error with Go to field. A new form with a field you forgot to give a label shows a warning; a duplicated variable is an error.
2. Choose Preview (Ctrl+P), Live entry. Enter a systolic of 400 and read the message; enter 150 and see the amber warning; enter weight and height and watch the BMI appear (Preview and testing).
3. Close the preview and choose Save (the builder has also been saving by itself; the toolbar says Saved at …).

Enlarge

8. Make it active and bind it to visits#

1. Go back to the Forms list and open Vital Signs. Choose Make active; the dialog lists any errors, and lets you continue when there are none (Versions, reopening and publishing).
2. Open Visit–Form Mapping. In the Vital Signs row, click the cell under Screening, choose Mapped; Shift+click the other visits, or use the form's menu Map to all visits (Binding a form to visits).
3. The design is now ready for the version to be submitted to UAT by whoever holds that permission. Nothing you did is visible to participants until the version has passed a cycle, been signed off by three people and gone Live.

Every option#

Every control used above, and all the others, are described on the pages linked at each step. The checks the example used are in Validation, edit checks and their severities; the formula functions in Formulas and calculations; the templates that save this work in The form library and templates.

What the system records#

Creating the form (form.created), every save (form.draft_saved), making it active (form.transitioned) and each binding (mapping.bound) are audit events with your name and the time, and each save is a revision of the version's draft design.

What you cannot do, and why#

• Skip the version's UAT. Making a form active does not release it; only a signed-off version does.
• Change the form after the version is submitted. It is frozen; return the version to Build (fail the cycle or reject the sign-off) or start an amendment.

Compliance Q&A#

No Q&A applies on this page; the pages it links to carry the compliance answers for each part of the build.

Related#

Overview · Design forms · Plan visits · Review and release a study · eCRF Designer