# REDCap for veterinary clinical trials: what it covers

REDCap can run a client-owned animal study. What your instance offers, what you build yourself, and what the rules ask of any system.

Canonical: https://signalment.app/guides/redcap-for-veterinary-clinical-trials/
Updated: 2026-10-12

Yes, a client-owned animal study can be run in REDCap, and a trials office that knows the software can cover most of what such a study needs. REDCap is a web application for building surveys and databases, available at no charge to non-profit organizations that join its consortium and install and support it themselves. It has an audit trail, record locking with electronic signatures, an e-Consent framework, a randomization module and a participant app called MyCap. None of it is specific to animals, and each part is switched on and configured project by project. The rules ask for the same records whichever system you use, so the questions for a trials office are which parts its own instance offers, who builds the study on them, and what a veterinary study needs that still has to be designed by hand.

## What the rules ask of the records

Three rules shape the records of a study in client-owned animals in the United States.

**21 CFR Part 11** applies, under section 11.1(b), to electronic records kept "under any records requirements set forth in agency regulations." Section 11.10 asks a closed system for validation, accurate and complete copies in human-readable and electronic form, access limited to authorized individuals, and "secure, computer-generated, time-stamped audit trails" that do not obscure earlier entries. Section 11.50 says a signed record shows the signer's printed name, the date and time, and the meaning of the signature, and 11.70 links each signature to its record. Section 11.100(c) puts one duty on the institution rather than the vendor: before using electronic signatures, it certifies to FDA, in a letter with a handwritten signature, that they are the legally binding equivalent of handwritten ones.

**FDA Guidance #85, VICH GL9**, is the good clinical practice standard that 21 CFR 514.117(b)(2) points to when it asks that a study follow "a standard of conduct acceptable to FDA" and that the protocol say so. GL9 1.15 defines informed consent as a documented process in which the owner voluntarily agrees to the animal taking part; 3.2.13 asks the investigator to obtain it first. Section 8.3.1 asks that raw data be "attributable, original, accurate, contemporaneous and legible." Section 8.3.6 says that when data are entered directly into a computer system, "the electronic record is considered the raw data," each entry and change is made under the electronic signature of the person making it, and changes are kept in an audit trail. GL9 asks both parties to comply with the rules on humane care of study animals (3.2.12, 4.2.17) but does not itself name an animal care committee.

**21 CFR 511.1** governs the shipment of an unapproved new animal drug for clinical investigation. Section 511.1(b)(4) asks the sponsor to file a Notice of Claimed Investigational Exemption before shipment. Section 511.1(b)(7) asks investigators to keep complete records, including each shipment's receipt and disposition, for two years after the study ends or the drug is approved. Section 511.1(b)(8) asks the sponsor to monitor the study, to report promptly to FDA and all investigators any finding that suggests a significant hazard, and never to represent the drug as safe or effective. The section says nothing about consent, ethics review or an adverse event form; those come from GL9 and your institution's rules.

FDA's October 2024 questions-and-answers guidance on electronic systems, co-issued by the Center for Veterinary Medicine, says an audit trail must capture all changes, who made them and when, with "the old value and the new value," and makes the sponsor, not the software vendor, responsible for Part 11. Guidance #287 adds that when raw data were collected by an electronic data capture system, "the audit trail should also be submitted."

## Where the study design changes the answer

| Design | Federal filing | Conduct standard | Electronic records |
|---|---|---|---|
| Observational or registry: usual care, nothing assigned | None | Your institution's rules; draft Guidance #282 recommends a consent form and GCP for every client-owned study | Part 11 does not apply; GL9 record discipline still makes the data usable |
| Marketed product used as labelled | None for the product | GL9 if the data are meant for FDA | Part 11 if the data are meant for FDA |
| Unapproved product, including compounded products and research peptides | Notice under 21 CFR 511.1 before shipment | GL9, through 514.117(b)(2) | Part 11 applies; the 511.1 record duties are the predicate |

REDCap's own site says it can be installed in environments that comply with 21 CFR Part 11. UCLA's REDCap office states the working condition: Part 11 "requires a REDCap project to have certain features enabled as well as extensive documentation by the study team." Whether your instance is validated and covered by the Part 11 letter is a question for its administrator. So is which modules it carries: Yale's REDCap office says MyCap is not available on its hospital's Part 11 instance.

## What REDCap covers, and what you add

From REDCap's own site and the published guidance of four university REDCap offices, read on 2026-10-12. Your instance may differ.

| Study need | REDCap | What the trials office adds |
|---|---|---|
| Case report forms | Yes | Fields, units and limits per protocol; how an owner and an animal are modelled |
| Audit trail | Yes, of data changes and user activity | A written lock procedure and an export that carries the audit trail |
| Electronic signatures | Record locking with an e-signature | Switching it on per form; the institution's Part 11 letter to FDA |
| Owner consent online | e-Consent framework: a signature field, a certification page, a PDF archived with a version label | The consent text, a new version at each amendment, and a rule that nothing is recorded before the signature |
| Owner records from a phone | Surveys by link; the MyCap app, with push notifications on days a task is due | The questions and the schedule; a check that MyCap is offered on your Part 11 instance |
| Randomization | A module that assigns from an allocation table you upload, with strata; a blinded option stores a randomization number | The table itself, who may see it, and a code-break procedure with its log |
| Adverse events with the 21 CFR 514.3 serious criteria | Build it | The seriousness criteria, a causality assessment, reporting dates |
| Scanned clinic records | File upload | Transcription into the forms, and a second check of it |
| Guidance on INAD, IACUC and VICH GL9 | Not its subject | Your own SOPs |

On randomization, the University of Wisconsin's guidance is direct: "REDCap does NOT automatically generate randomized tables for you," the tables "should be created with the help of a statistician," and "Once a record has been randomized it CANNOT be undone." It describes separate user rights to set up, to randomize and to view the allocation dashboard. It describes no procedure for breaking the blind, so that procedure and its log are yours to write.

21 CFR 514.3 defines a serious adverse drug experience as an event "that is fatal, or life-threatening, or requires professional intervention, or causes an abortion, or stillbirth, or infertility, or congenital anomaly, or prolonged or permanent disability, or disfigurement"; a form with those fields saves a reconstruction later. And draft Guidance #282 recommends the owner receive the consent form 12 to 24 hours before enrollment and that it never suggest the product is "safe" or "effective."

## Before you build, decide these

1. Which row of the design table the study is in. If a product is supplied without approval for that use, the sponsor's 511.1 notice comes first.
2. Whether the data are meant for a regulatory authority. If yes, GL9 and Part 11 follow.
3. Who is the sponsor, the investigator and the monitor; GL9 3.1.5 keeps the last two separate.
4. Whether the Part 11 letter under 11.100(c) is filed, the REDCap instance validated for this use, and which modules that instance carries.
5. How the owner consents and records at home, and how the version of the consent text the owner signed is recorded.
6. Who generates the allocation table, who holds it, how it is concealed, and where a code break is logged.
7. What the adverse event form contains, and who reports what to whom within what time.
8. How the database is locked and how the export carries the audit trail Guidance #287 asks for.
9. How long the records are kept; the 511.1 clock can run from an approval years after the study ends.

## What stays yours

Whatever system holds the records, the protocol and its amendments, the ethics review, the content of the consent form, the Notice of Claimed Investigational Exemption, the monitoring, and every report to FDA or to a sponsor are the sponsor's and the investigator's responsibility. A data system makes those duties possible to show. It does not discharge them, nor decide whether a study needs review at your institution.

## Where Signalment fits

Signalment is electronic data capture for studies in client-owned animals. The rules treat it exactly as they treat REDCap. The difference is that the veterinary study arrives built: an owner eDiary with eConsent from the owner's phone, bound to the text version the owner read; randomization in permuted blocks with concealed allocation, blinding and a logged code break; an adverse event form with the 514.3 serious criteria and ABON causality; scanned clinic records read into proposed form lines, accepted by a person; an append-only, hash-chained audit trail a monitor verifies offline; and a lock with a fingerprint. It is self-serve, with no server to run. The owner's side is shown at [signalment.app/owners](https://signalment.app/owners/).

Not built yet: VeDDRA coding, drug accountability ledgers, SAS and SEND exports, site-scoped roles for multi-site programmes, single sign-on and an API. If your team has already built the study in REDCap, staying there is a sound choice. Running the next client-owned study in a system that arrives built around owners is another. For ten questions to ask any vendor, see [Veterinary EDC, explained](/guides/veterinary-edc-explained/).

## Sources

- 21 CFR Part 11, electronic records and electronic signatures: https://www.ecfr.gov/current/title-21/part-11
- 21 CFR 511.1, new animal drugs for investigational use: https://www.ecfr.gov/current/title-21/section-511.1
- 21 CFR 514.117, adequate and well-controlled studies: https://www.ecfr.gov/current/title-21/section-514.117
- 21 CFR 514.3, definitions: https://www.ecfr.gov/current/title-21/section-514.3
- FDA Guidance #85, VICH GL9, Good Clinical Practice: https://www.fda.gov/media/70333/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 Guidance #287, Raw Data for Safety and Effectiveness Studies (June 2025): https://www.fda.gov/media/177901/download
- FDA Draft Guidance #282, Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals (September 2023): https://www.fda.gov/media/172056/download
- REDCap, software features: https://projectredcap.org/software/
- REDCap, joining the consortium: https://projectredcap.org/partners/join/
- UCLA Clinical and Translational Science Institute, REDCap FDA projects: https://ctsi.ucla.edu/researcher-resources/data-and-informatics-tools/redcap/advanced-redcap-learning/fda-projects
- University of Wisconsin-Madison, REDCap: Randomization: https://kb.wisc.edu/smph/informatics/148483
- University of Connecticut, REDCap eConsent presentation: https://health.uconn.edu/clinical-research-center/wp-content/uploads/sites/50/2023/06/eConsent-Presentation-1.pdf
- Yale University, MyCap primer: https://portal.redcap.yale.edu/posts/2025-07-23-mycap-primer