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The owner’s side of a study

From one email to the FDA file.

Field studies live or die on what owners record at home. Follow one owner, one dog and one evening’s check-in through every step: consent, the daily questions, the clinic, the signature, the audit trail, the lock and the export.

Example study EVM-01. The animals, people and clinic are fictitious. Every screen is from the product. 1 min 43 s, with captions.

  1. 01Invite

    One email. One tap.

    The study team adds the owner’s email when they enroll the animal. The owner gets a plain invitation from the clinic, taps once, and makes a free account in the phone’s browser. There is nothing to install.

    The invitation email from Ridgeway Veterinary Research, with an Open the study button.

    TUE JUN 23 · 7:38 PM · invitation opened · account created 7:39 PM

    The study team The subject list shows who has been invited and who has joined.

  2. 02Consent

    Consent that proves what was read.

    The form opens in plain sections. The Sign button stays locked until the owner reaches the end, and the signature is bound to a SHA-256 hash of that exact version of the text. Change one word and the hash changes.

    The consent form opening on the phone, in plain sections.
    Signed, version 2: a confirmation that a copy stays in the owner’s account.

    CONSENT v2 · text 16ae26f343da410e… · signed 7:43 PM

    The study team Consent version and time sit on the subject’s page; paper consent can be recorded instead.

  3. 03Check-in

    One question at a time.

    Better, the same or worse. How long the walk was. How the day felt. A photo, with location data stripped before it is stored. Review, save: twenty-four seconds, and a receipt the owner can see.

    Overall, compared with the start of the study: Better is selected.
    How did today feel overall, on the owner’s own 1 to 5: 4 is selected.
    A photo added to the entry.
    Saved in 24 seconds, 13 days in a row, with a receipt.

    JUL 16 · DAY 22 · Better · 30 min · 4/5 · saved in 24 s · receipt 291fe38ab311

    The study team Forms come from the protocol; owners see only the questions written for them.

  4. 04Record

    A record that keeps itself.

    A seven-day ring, a streak worth protecting, a trend line and a calendar. A missed day stays a gap. When an owner logs a past day, the entry carries the time it was really made, set by the server’s clock and sealed into its receipt.

    Today, done: a seven-day ring, a 13-day streak, 24 entries and a trend chart.
    History: a 28-day calendar where July 3 stays empty, and trend rows for each question.

    JUL 3 · DAY 9 · not recorded · the calendar stays empty

    The study team Missed diary days show on the visit schedule, ready for a deviation note.

  5. 05Clinic

    At the clinic the same minute.

    The entry lands on the subject’s page as soon as it is saved, under the code EVM-001, marked with its source. Nobody retypes a diary card.

    The subject page for EVM-001 at the clinic: the visit schedule and the record list with the July 16 check-in.

    EVM-001 · daily:22 · entered 8:41 PM · source participant

    The study team Coordinators and investigators see entries arrive; monitors see everything except owner identities.

  6. 06Signature

    Verified with a signature.

    The investigator reviews the entry against its source and signs. Signing asks for the password again and records the name, the time and the meaning, bound to the record’s fingerprint.

    The investigator’s signing panel, asking for the password again.
    The check-in marked Verified.

    VERIFIED · Dr Ana Rivera · Jul 17, 9:12 AM · password re-entered

    The study team A workspace can require a recent password change before anyone signs.

  7. 07Audit

    An audit trail anyone can check.

    Every create, change, signature and export is an entry on a hash-chained trail. A monitor can recompute every hash from the export on their own laptop, with no account and no network.

    The audit trail: 629 entries, hash-chained, verifying from the first entry to the last.
    $ node verify-export.mjs export.json
study EVM-01 · signalment.export.v1 · SHA-256
records      302 recomputed · chain holds
audit trail  627 entries recomputed · 625 links checked · holds
signatures   307 · consents 6
lock         fingerprint matches a9ec795791ea340c…
✓ OK · the chain holds from the first entry to the lock

    The study team You can run the same check below, in this browser, on the real record.

  8. 08Lock

    Locked with a fingerprint.

    When every query is closed and every record verified, the investigator locks the database. The lock signs one SHA-256 fingerprint over every record, consent and signature.

    The study locked on September 30 at 2:02 PM, with its SHA-256 fingerprint.

    LOCKED · SEP 30 · 2:02 PM · a9ec795791ea340c606c06f18e1c1f5a…

    The study team Unlocking needs a reason and the password again, and goes on the trail too.

  9. 09FDA

    To the sponsor, for the submission.

    The export is a JSON bundle with the audit trail, one CSV per form and a data dictionary, with subject codes only. The sponsor prepares and files its own submission to FDA’s Center for Veterinary Medicine. Signalment keeps the records it is built from.

    The study team Signalment is not a party to the submission and makes no claim on the agency’s behalf.

Check it yourself

Change one answer. Watch the record stop matching.

This is record #80, Juniper’s check-in from July 16, exactly as the export carries it. Your browser hashes it with SHA-256 the way a monitor would. Change an answer and the hash no longer matches the receipt, or the record after it.

Nothing here is sent anywhere. The hashing runs on this page.

Receipt in the export
291fe38ab311de65c8d6dc66d411861ac10e1dcfb4bab5a4ee86ff85968906d0
Hash of what is in the form
Hashing in your browser…
Record #81 points back at
291fe38ab311de65c8d6dc66d411861ac10e1dcfb4bab5a4ee86ff85968906d0

For the people who run the study

Run your next field study with owners who keep the diary.

Set up a study from a template, invite an owner, and see their first check-in arrive the same minute. The owner eDiary and eConsent come with every plan.

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