A resident's thesis study with client-owned animals runs in four stages. Set it up: write the protocol and the owner consent form, and have both approved by the review your college requires before the first animal enrolls. Consent: give each owner the form ahead of time and get the signature before any study procedure. Record: enter each observation on a pre-set form when it is made, under the name of the person who made it, with a reason for every correction. Lock: when the last record is in and every query is closed, lock the database and export it with its audit trail. A study of usual care, or of an approved drug used as labelled, needs no investigational filing; one that gives an unapproved drug needs an exemption under 21 CFR 511.1 before the drug ships.
Which rules apply to which design?
| Design | FDA filing | Conduct standard | Electronic records |
|---|---|---|---|
| Observational: usual care, nothing assigned | None | Good practice; outside GL9 (2.6) unless meant for a regulator | Part 11 only if sent to FDA |
| Approved drug used as labelled | None | GL9 if meant for FDA | Part 11 only if sent to FDA |
| Unapproved drug | Notice of claimed investigational exemption before shipment, 21 CFR 511.1(b)(4) | GL9 if meant for FDA | Part 11, since 511.1(b)(7)(ii) is an FDA records requirement |
GL9 (FDA Guidance #85) is the good clinical practice standard for veterinary studies. Section 2.6 puts "basic exploratory studies or other clinical studies not intended to be used for regulatory support" outside its scope. A thesis not headed to a regulator is outside it, though following GL9 leaves records an examiner can check. For every design, CVM's draft Guidance #282 (September 2023, not yet final) says "CVM recommends all studies conducted with client-owned companion animals use an ICF", an informed consent form, for dogs, cats and horses.
FDA's reporting page recommends calling the drug company about an adverse event with an approved drug; the company "is required to submit reports of adverse drug events to FDA". Form FDA 1932a can be used for any animal drug.
With an unapproved drug, 21 CFR 511.1 governs. The sponsor files its notice before shipment (b)(4). The investigator keeps complete records, including the receipt and disposition of each shipment, for two years after the study ends or the drug is approved (b)(7)(ii). The sponsor promptly reports to FDA and all investigators any finding that may suggest a significant hazard (b)(8)(ii), and must not represent the drug as safe or effective for the use under investigation (b)(8)(iv). Name the sponsor in writing; GL9 1.26 lets it be an "individual, company, institution or organization".
The protocol and the review
GL9 6.3 is a protocol checklist worth using at any scope: a unique identifier with status and version date (6.3.2), randomization and blinding (6.3.8), inclusion, exclusion and removal criteria (6.3.10), endpoints and how they are measured (6.3.16), a justified sample size (6.3.17), how raw data are recorded and kept (6.3.18), adverse event procedures (6.3.19), and copies of the data forms and owner information (6.3.20). Investigator and sponsor sign and date it (1.29), and no one should be both investigator and monitor (3.1.5).
At UC Davis, the Clinical Trial Review Board pre-reviews all protocols involving teaching hospital patients before the IACUC, and a clinical trial's protocol must have an owner informed consent form attached. Texas A&M's veterinary school requires its Clinical Research Review Committee's approval "if non-residual sample collection, diagnostics, treatment, or animal care is influenced by considerations other than the needs of the patient", and asks for the animal use protocol and consent form five weeks before the monthly meeting. By that test, an observational study that adds one blood draw for the study goes to the committee. Your college's own rules decide, and the review takes weeks of the residency.
Consent
Draft #282 asks the investigator, whenever possible, to give the owner the form at least 12 to 24 hours before enrollment (section II), at a 5th or 6th grade reading level where possible (V.A). It recommends avoiding the enrollment of animals owned by investigators, employees or relatives of investigators or the sponsor (V.B), which argues against recruiting colleagues' pets. Its confidentiality section should say how the data will be used, for example published (VI.G). For an unapproved product, the form states that it is investigational and that safety and effectiveness have not been demonstrated (VI.A.1).
A journal can ask for both the approval and the consent. Frontiers' policy, for one, says studies with client-owned animals should "confirm that written informed consent has been granted by the owner(s)", and that research with regulated animals must be "reviewed and approved by an ethics committee prior to commencing the study".
Records
GL9 8.3.1 asks that raw data be "attributable, original, accurate, contemporaneous and legible"; in an automated system, whoever enters data records their name and the date at input. Under 8.3.6, data entered directly into a computer are 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. The owner's consent counts as raw data (8.2.2.1), and draft #282 asks that owners keeping a diary be given the means to record the same way (VI.A.4).
Part 11 reaches electronic records kept under an FDA records requirement or submitted to FDA (11.1(b)). It asks for secure, computer-generated, time-stamped audit trails (11.10(e)), signatures that show the printed name, the date and time and the meaning (11.50(a)), and, before electronic signatures are used, the organization's certification letter to FDA (11.100(c)).
The lock
GL9 never says "database lock", but it defines the final study report as one written "after the collection of all raw data is complete" (1.13), and the lock marks that point. Close the queries, have the investigator sign off, lock, and export at once with the audit trail. For studies sent to CVM, Guidance #287 says "The audit trail should also be submitted if raw data were collected by an electronic data capture system" (section III). In a blinded study, open the allocation after the lock; GL9 3.2.18 lets a treatment code be broken only as the protocol says and with the sponsor's knowledge and consent. More in How to lock a study database.
The steps
- Fix the design and, if a drug is given, its status; name the sponsor, the investigator and the monitor.
- Write the protocol from GL9 6.3 and the consent form from draft #282 section VI.
- Submit both to the college's review and, where required, the IACUC; for an unapproved drug, the sponsor files under 511.1(b)(4) before shipment.
- Build the forms and owner diary from the approved protocol, and test them with a dummy record.
- Give each owner the form 12 to 24 hours ahead where possible; get the signature before any procedure.
- Record at the time of observation; correct with a reason, never by overwriting.
- Record adverse events and deviations as they happen; report them as the design requires.
- Close the queries, sign off, lock and export; analyse the export and keep it with its audit trail and the signed forms.
What stays with the people running the study?
The protocol, the review submissions, the consent wording, any notice under 511.1, every adverse event report, the Part 11 certification letter, the analysis and the thesis belong to the investigator, whether that is the resident or the supervisor, and to the sponsor. GL9 4.3.1 keeps the "ultimate responsibility for the quality and integrity of the study data" with the sponsor. A data system cannot approve a study or decide what an owner is told.
Signalment and a resident's study
Signalment is a data system. A study is set up from a template in about ten minutes, with versioned protocol and consent, case report forms, an owner eDiary with eConsent from the owner's phone, an append-only, hash-chained audit trail and a database lock with a fingerprint. The export is CSV per form, a data dictionary and a JSON bundle whose audit chain a monitor can verify offline. The free Pilot plan holds two open studies of 25 subjects each and five team members. It does not yet offer SAS exports or single sign-on. How an owner sees a study is at signalment.app/owners.
Sources
- FDA Guidance #85, VICH GL9, Good Clinical Practice: https://www.fda.gov/media/70333/download
- FDA CVM draft Guidance #282, Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals (September 2023): https://www.fda.gov/media/172056/download
- FDA Guidance #287, Raw Data for Safety and Effectiveness Studies (June 2025): https://www.fda.gov/media/177901/download
- 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, How to Report Animal Drug and Device Side Effects and Product Problems: https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems
- University of California, Davis, Office of Research, VMTH Clinical Trials: https://research.ucdavis.edu/research-support/animal-care-use/iacuc/vmth-clinical-trials/
- Texas A&M College of Veterinary Medicine, Clinical Research Review Committee: https://vetmed.tamu.edu/research/clinical-trials/crrc/
- Frontiers, Policies and publication ethics: https://www.frontiersin.org/guidelines/policies-and-publication-ethics