Guide · QuestionnairesUpdated September 28, 2026

How to design a clinical research questionnaire

Most studies use a mix of validated instruments and questions written for the study. The validated ones are fixed; the rest are where studies go wrong. A step-by-step guide to writing questions that measure what you think they measure.

  • Validated first
  • One idea per question
  • Test before you field

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Daily check-in

Question 2 of 5

In the last 24 hours, how often did you feel short of breath while walking?

NeverRarelySometimesOftenAlways
Recall period in the question itself

The short version

  • Use a validated instrument when one exists for your concept and population. Writing your own is slower and gives results others cannot compare.
  • For study-specific questions, write one idea per question, in plain language, with the recall period in the question.
  • Choose response options that are balanced, exhaustive and consistent across questions.
  • Test the questionnaire with people like your participants (cognitive interviews) before the study starts.
  • Design for the screen participants will use: short items, one question per screen on phones, no preset answers on sliders.

Step by step

From concept to fielded questionnaire

  1. 1

    Define the concept

    Write down exactly what you want to measure, in whom, and how the answer will be used in analysis.

  2. 2

    Look for an instrument

    Search for validated instruments for that concept and population; check licensing and translations.

  3. 3

    Write the rest

    Draft study-specific items with clear wording, recall periods and response options.

  4. 4

    Test and refine

    Cognitive interviews with a handful of target participants, then a pilot on the real device.

Writing items

Rules for questions that measure what you mean

Questionnaire problems are usually wording problems. Participants answer the question they think you asked, and if it can be read two ways, some will read it the other way. The fixes are simple and well established.

One idea per question

"How often did you feel tired and irritable?" asks two things. A participant who was tired but not irritable has no correct answer. Split double-barrelled questions.

Put the recall period in the question

"In the last 7 days" or "today" belongs in every item, not only in the instructions. Match the recall period to how often the questionnaire is given: a two-week recall collected weekly overlaps itself.

Balanced, exhaustive response options

Offer as many positive as negative options, cover every possible answer (including "not applicable" where relevant), and use the same scale direction throughout. Frequency (never to always), intensity (none to very severe) and agreement scales measure different things; do not mix them within one item.

Avoid leading and loaded wording

"How much has the treatment improved your sleep?" assumes improvement. "How would you rate your sleep in the last 7 days?" does not.

Plain language

Write for a reading age around 11 to 12 where possible, avoid medical jargon and abbreviations, and use official translations for validated instruments. For your own items, translate and back-translate.

Number
Scale
Slider
Date
Date and time
Free text
Single choice
Multiple choice
Dropdown
Yes / No
Haematology (table section)
AnalyteResultUnitRef. range
Haemoglobin13.8g/dL13.0 to 17.0
White blood cells6.210^9/L4.0 to 10.0
Platelets41210^9/L150 to 400

Response formats

Choosing a response format

FormatGood forWatch out for
Numeric rating scale (0 to 10)Intensity of symptoms such as painAnchors must be defined at both ends.
Verbal rating scaleFrequency or severity in wordsKeep categories balanced and ordered.
Visual analogue scaleFine-grained continuous ratingsNo preset marker; some participants find it harder.
Yes / noEvents that clearly happened or notLoses information about degree.
Multiple choiceSeveral things that can all applyNeeds "none of the above".
Number or timeCounts, durations, clock timesUnits and ranges defined.
Free textExploration, other symptomsNot analysable at scale; use sparingly.

Build it

Ten question types, previewed on the device participants use

Capture offers ten question types (short text, number, linear scale, slider, single choice, multiple choice, dropdown, date, time and long text) with skip logic and required fields. Visual analogue scales have no preset value, and the phone layout wraps long items rather than truncating them. Preview the participant view on your own phone before the study starts.

  • AI drafts questions from a description or file for you to review.
  • Coded values and labels in every export.
  • Blank ePRO PDF in phone layout for ethics review.
How to capture PROs digitally
Clinic tablet · landscape5 of 12

How much pain do you feel right now?

No painWorst pain
BackNext

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FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

How many response options should a rating scale have?

Commonly five to seven labelled options for agreement or frequency scales, or a 0 to 10 numeric scale for intensity. Keep direction and labels consistent across items.

Should questions include a 'don't know' option?

Include one when not knowing is a genuine, meaningful answer. Otherwise it can become an easy way out, so decide item by item.

Should I write my own questionnaire or use a validated one?

Use a validated instrument when one exists for your concept and population. Write your own only for what no instrument covers.

What is a recall period?

The time window a question asks about, such as the last 24 hours or the last 7 days. Put it in each question and match it to how often the questionnaire is given.

What is cognitive interviewing?

Asking a few people like your participants to think aloud while answering, to check they understand each question as intended.

How long should a questionnaire be?

As short as possible for the endpoints. Burden drives missing data, especially for repeated questionnaires.

Can I build and test a questionnaire free?

Yes. The free sandbox includes every question type and a phone preview.

Questions participants understand

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