Veterinary EDC, explained

Electronic data capture, EDC, is the system that holds a study's records: the forms the site fills in at each visit, what owners record at home, the consent, the randomization, the adverse events, the monitor's queries, the signatures, the audit trail and the export at the end. It replaces the binder and the spreadsheet. In a veterinary field study the owner is a source of data in their own right, recording from home between visits, which is the main way these studies differ from the human trials most EDC systems were built for.

The parts, and what each is for

• Case report forms (eCRFs). The structured forms for enrollment, examinations, laboratory results, dosing, concomitant medications, deviations and end of study. Each field has a type, units and limits, so a weight cannot be entered as a word.
• The owner eDiary. The owner's daily or weekly questions, answered on their own phone. Human trials call this ePRO, where the patient reports; here the owner reports on the animal.
• eConsent. The consent text, versioned, signed by the owner before the animal takes part, with a copy they keep. GL9 counts the signed consent as raw data.
• Randomization and blinding. The allocation list, concealed until each animal is enrolled; the arm hidden from whoever is blinded; a code break logged with its reason.
• Adverse events. A form that carries the seriousness criteria of 21 CFR 514.3 and a causality assessment, with the dates the event was reported.
• Queries. The monitor's questions on a record, the site's answers, and who closed them.
• Signatures. Verification by the investigator, and activation and lock by the study's owner, each re-checking identity and recording what the signature means.
• The audit trail. Who did what, when, and why, for every record and every change, including the old and new values.
• The lock and the export. The database closed with a fingerprint, then one file per form, a data dictionary and a bundle with everything above.
• Document intake. Scanned clinic records read into proposed form lines for a person to accept, so nothing is retyped.

What the rules ask of the records

For studies meant for FDA, Guidance #85 (VICH GL9) section 8.3 says raw data must be attributable, original, accurate, contemporaneous and legible; that when data are entered directly into a computer system the electronic record is the raw data; that each entry and change is made under the electronic signature of the person making it; and that changes are kept in an audit trail with the reason. The 2024 FDA questions-and-answers guidance on electronic systems, which CVM co-issued, says the audit trail must capture all changes, who made them and when, with the old value and the new value, and should be searchable and sortable.

21 CFR Part 11 applies to electronic records kept under an FDA records requirement. Its closed-system controls (11.10) include validation, accurate and complete copies in human-readable and electronic form, access limited to authorized people, secure computer-generated time-stamped audit trails that do not obscure earlier entries, and checks on who may sign or alter a record. Signed records show the signer's printed name, the date and time, and the meaning of the signature (11.50), and signatures are linked to their records (11.70). One duty sits with the organization, not the vendor: before using electronic signatures on FDA-regulated records, it certifies to FDA in a letter that its electronic signatures are the legally binding equivalent of handwritten ones (11.100(c)).

Guidance #287 adds that when raw data were collected by an EDC system, the audit trail is submitted with them. An observational study with nothing assigned is outside Part 11, but the same records discipline is what makes the result usable later.

The options

As of September 2026, from each vendor's public materials, with the REDCap column re-read on 12 October 2026; check them before you decide.

REDCap deserves a word on its own because most veterinary colleges already run it. It is good at surveys and at forms a trained team fills in, and it costs nothing to non-profit institutions that join its consortium and host it. It also carries more of the owner's side than it is often given credit for: an e-Consent framework that archives the signed form as a PDF with a version label, a participant app called MyCap, and a randomization module that assigns from an allocation table the team uploads. Each is set up per project, and not every instance offers each one. What a team still designs for a veterinary study is how owners and animals are modelled, the diary schedule, who generates and holds the allocation table and how a code break is logged, the adverse event form, and a lock whose fingerprint a reviewer can recompute. Keeping REDCap for what your team has built there and running the next client-owned study in a system that arrives built around owners is a reasonable split. There is more in REDCap for veterinary clinical trials.

Ten questions to ask any vendor

1. Can an owner sign consent and record from their own phone, with nothing to install?
2. Is each consent bound to the exact version of the text the owner read?
3. Is allocation concealed until enrollment, and is every code break logged with a reason?
4. Does the audit trail keep the old value, the new value, the person, the time and the reason for every change, and can I export it?
5. Do signatures show the signer's name, the time and the meaning, and re-check identity before signing?
6. Does the adverse event form carry the 21 CFR 514.3 seriousness criteria and a causality assessment?
7. Can I lock the database and later prove nothing changed after the lock?
8. Can a monitor verify the records from the export alone, without trusting the vendor?
9. What comes out: one file per form, a data dictionary, and a bundle with the audit trail?
10. What is the price per study, and how long is the implementation project?

Check an export yourself

Signalment publishes the check a monitor would run: a short script that recomputes every record hash, every audit entry and the lock fingerprint from the exported bundle, on your own computer, with no account and no network. It is at signalment.app/verify-export.mjs and runs with node verify-export.mjs export.json. The sponsor film at signalment.app/sponsors shows it run on a locked example study. For what the study itself involves, see How to run a clinical study for a pet supplement.

Sources

• FDA Guidance #85, VICH GL9, Good Clinical Practice: https://www.fda.gov/media/70333/download
• 21 CFR Part 11, electronic records and signatures: https://www.ecfr.gov/current/title-21/part-11
• FDA, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2024): https://www.fda.gov/media/166215/download
• FDA Guidance #287, raw data for safety and effectiveness studies: https://www.fda.gov/media/177901/download
• 21 CFR 514.3, definitions: https://www.ecfr.gov/current/title-21/section-514.3
• FDA, letters of non-repudiation agreement: https://www.fda.gov/industry/getting-started-esg-nextgen/letters-non-repudiation-agreement
• REDCap, software features (read 2026-10-12): https://projectredcap.org/software/
• REDCap, joining the consortium (read 2026-10-12): https://projectredcap.org/partners/join/
• University of Wisconsin-Madison, REDCap: Randomization (read 2026-10-12): https://kb.wisc.edu/smph/informatics/148483
• University of Connecticut, REDCap eConsent presentation (read 2026-10-12): https://health.uconn.edu/clinical-research-center/wp-content/uploads/sites/50/2023/06/eConsent-Presentation-1.pdf
• Yale University, MyCap primer (read 2026-10-12): https://portal.redcap.yale.edu/posts/2025-07-23-mycap-primer