Most validated owner questionnaires for dogs and cats measure chronic pain and mobility: for dogs, the Canine Brief Pain Inventory (CBPI), Liverpool Osteoarthritis in Dogs (LOAD), the Helsinki Chronic Pain Index (HCPI) and the Canine Orthopedic Index (COI); for cats, the Feline Musculoskeletal Pain Index (FMPI) and Client Specific Outcome Measures (CSOM). Each was tested in a named condition, language and recall period, so give it unchanged, on that schedule, with the rights holder's written permission. The CBPI asks about the last 7 days, so it belongs at weekly or visit time points. Collect what owners see each day (doses, appetite, vomiting, anything new, a photo) in a separate study-defined diary on their phone, at a set time, each entry dated and attributed to whoever made it.
Which questionnaires are validated
| Instrument | Condition | Evidence | Rights |
|---|---|---|---|
| CBPI | Dogs; chronic pain | 4 severity and 6 interference items, 0 to 10, over the last 7 days; correlated with LOAD and the HCPI in 222 dogs (Walton, 2013) | PennCHART, in English, French and Swedish; translations need the developer's permission |
| LOAD | Dogs; osteoarthritis | Same 222 dogs; minimal clinically important difference (MCID) of 4 points (Alves and Innes, 2023) | University of Liverpool, under an exclusive commercial licence |
| HCPI | Dogs; osteoarthritis | Same 222 dogs | University of Helsinki; no published terms |
| COI | Dogs; orthopedic disease | Stiffness, function, gait and quality of life; MCID of 14 points (Alves and Innes, 2023) | American College of Veterinary Surgeons; on PennCHART |
| FMPI and its short form | Cats; chronic musculoskeletal pain | FMPI tested in a double-masked crossover trial of 66 cats (Gruen, 2015) | NC State, on request; English, French and Spanish |
| CSOM | Cats; degenerative joint disease | Three activities the owner chooses; same 66 cats | NC State, on request |
Some carry terms that bar commercial use without written authorization, and Penn Vet's page states none, so ask each rights holder in writing for your use: a sponsored study, an electronic form, each language.
The limits of a validation
- The owner is an observer. FDA's 2009 guidance on patient-reported outcomes, issued for human medical products and not by CVM, encourages observer reports "that include only those events or behaviors that can be observed" for patients who cannot respond for themselves (III.G). Write your own diary questions about what the animal did, not what it felt.
- Format. The same guidance lists paper-to-electronic moves, reordered items, and changed wording, response options or recall period among changes that can alter answers (III.F).
- Language. A translation is a new version: Wells and colleagues (2021) linguistically validated eight more CBPI versions through forward and back translation and interviews with five owners per country.
- Expectation. In a placebo-controlled crossover trial of 66 cats, Gruen and colleagues (2015) found "a sizeable caregiver placebo effect" in the first period; the FMPI detected improvement in the crossover design but not the parallel one. Mask owners where you can; see Randomization and blinding in client-owned animal studies.
- Change. In Walton and colleagues' longitudinal cohort, score changes did not correlate significantly with force-plate changes. Fix the responder threshold before unblinding.
What the rules ask
For a study meant to support an FDA approval, 21 CFR 514.117(b)(8) asks for "methods to assess animal response that are well defined and reliable," and (b)(7) for methods that minimize bias "on the part of observers and analysts of the data." An owner scoring their own animal is an observer.
Guidance #85 (VICH GL9) asks the protocol to "specify the timing and frequency of study observations" (6.3.16.3), define any scoring system (6.3.16.5), and attach every data capture form and the information given to owners (6.3.20.2, 6.3.20.3). Raw data should be contemporaneous, "recorded at the time of observation," and when more than one person observes or records, "that fact should be reflected in the data entries" (8.3.1). Data entered directly into a computer system are the raw data (8.3.6); transcribed data are not (1.24), so a paper diary typed in later stays the original. Guidance #287 asks for the audit trail when raw data came from an electronic data capture system (III).
FDA's 2024 questions and answers, which CVM co-issued, say that when a caregiver or anyone else enters data for the participant, that person is the data originator and the reason is documented (Q20). In a pet study that is the owner, or staff keying in answers taken by phone. Each person uses their own username and password (Q21), and transmission should occur "contemporaneously or as soon as possible after data are recorded" (Q22). Part 11 covers electronic records kept under an FDA records requirement or submitted to FDA (11.1(b)), and its audit trails must not obscure earlier entries (11.10(e)).
By study design
| Design | What applies to the owner's answers |
|---|---|
| Observational study or registry, nothing assigned | GL9 leaves out studies not intended for regulatory support (2.6), and Part 11 reaches only records kept under an FDA requirement or submitted to FDA. The instrument's terms, the protocol and the institution's ethics rules still apply. |
| Marketed product used on label | No INAD for the product. If the study supports an FDA submission, 514.117 and GL9 apply, and each problem an owner reports is an adverse event for the investigator to assess. |
| Unapproved product under an INAD | The investigator "shall maintain complete records of the investigations" and keeps copies 2 years after the study ends or the drug is approved (511.1(b)(7)(ii)). An electronic diary is part of those records, so Part 11 applies. Neither the sponsor nor anyone acting for it may represent the drug as safe or effective (511.1(b)(8)(iv)); word diary questions and reminders accordingly. |
Steps for a daily owner diary
- Name in the protocol the endpoint, instrument, version, language and schedule, keeping each instrument on its own recall: the CBPI weekly or at visits.
- Get written permission for this use. Keep the wording, item order, response options and scoring as published, and put screenshots of the electronic form in the protocol (2009 guidance, IV.A).
- Put the daily questions in a separate study-defined form: each dose and its time, appetite, vomiting or diarrhea, anything new, a photo when something changes. Keep it short, in a fixed order, at a set time. One CBPI item asked daily is a new measure, not the CBPI.
- Set a window for each entry and say in the analysis plan how late and missed entries are handled; FDA's 2009 guidance looks for protocol steps against entries made "just before a clinic visit" (III.D.2).
- Name one respondent per animal where possible, and record who answered each time.
- Send every new sign an owner reports to the investigator, who should "promptly notify the sponsor of adverse events" (GL9 3.2.17).
- Tell owners their obligations before the first entry (GL9 3.2.14) and train them on the form, with the training documented (2024 guidance, Q15).
What stays with the sponsor and the investigator
The endpoint and instrument, the licence and any translation, the protocol and schedule, the analysis plan and responder threshold, the ethics review, the consent text (what owners record, and how often), the assessment of each adverse event, and any filing or report to FDA or an approval holder stay with the sponsor and the investigator. A data system holds the answers; it does not make an instrument valid or a study adequate.
Where Signalment fits
Signalment is a data system. Owners sign consent and answer the eDiary on their own phone, one question per screen, with photos and calendar reminders; scored questionnaires and owner reminder emails have been in the product since October 13, 2026. It embeds no licensed instrument: a study that holds a licence adds it as a custom form, in the rights holder's wording. Every entry and change goes on an append-only, hash-chained audit trail, and the export is a CSV per form, a data dictionary and a JSON bundle. Offline capture is not built yet, so owners need a connection to submit. See the owners page.
Sources
- 21 CFR 514.117, adequate and well-controlled studies: https://www.ecfr.gov/current/title-21/section-514.117
- 21 CFR 511.1, new animal drugs for investigational use: https://www.ecfr.gov/current/title-21/section-511.1
- 21 CFR Part 11, electronic records and electronic signatures: https://www.ecfr.gov/current/title-21/part-11
- FDA Guidance #85, VICH GL9, Good Clinical Practice: https://www.fda.gov/media/70333/download
- FDA Guidance #287, Raw Data for Safety and Effectiveness Studies (June 2025): https://www.fda.gov/media/177901/download
- FDA, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations, Questions and Answers (October 2024): https://www.fda.gov/media/166215/download
- FDA, Patient-Reported Outcome Measures, Use in Medical Product Development to Support Labeling Claims (December 2009): https://www.fda.gov/media/77832/download
- Penn Vet, PennCHART questionnaires: https://www.vet.upenn.edu/ryan-hospital/clinical-trials/pennchart/
- NC State, clinical metrology instruments: https://cvm.ncsu.edu/research/labs/clinical-sciences/comparative-pain-research/clinical-metrology-instruments/
- Walton and colleagues, validity of LOAD, CBPI and HCPI (PLOS ONE, 2013): https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058125
- Wells and colleagues, CBPI translations (Frontiers in Veterinary Science, 2021): https://www.frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2021.769112/full
- Alves and Innes, MCIDs for LOAD and the COI (PLOS ONE, 2023): https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0291881
- Gruen and colleagues, cat mobility instruments (PLOS ONE, 2015): https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0131839