Good laboratory practice and good clinical practice

Good clinical practice governs trials in humans. In the United States it rests on two parts of the regulations, one covering the protection of human subjects and informed consent^[S1] and one covering institutional review boards,^[S2] together with the international guideline adopted by the agency as a guidance document in September 2025.^[S3] Good laboratory practice is a separate regime that governs nonclinical laboratory studies.^[S4] This article covers where the boundary between them falls, because that is the part a sponsor commissioning nonclinical work has to get right.

What each regime covers

The clinical regime is directed at protecting the people enrolled in a trial and at the reliability of the data collected from them. It governs consent, the review board that approves the protocol, how the trial is conducted and monitored, and how records are kept.^[S1][S2][S3] The nonclinical regime is directed at the reliability of laboratory study data. It applies to an individual study, not to a facility, and it sets requirements for the study director, the independent quality assurance unit, the protocol, the raw data and the final report.^[S4] Neither regime substitutes for the other, and a laboratory compliant with one is not thereby compliant with the other.

What crosses the boundary

What the nonclinical package carries

Nonclinical work characterizes the compound in animals and in vitro. Its regulatory output is specific: the application to begin clinical work must contain adequate pharmacological and toxicological information supporting the sponsor conclusion that the proposed investigation is reasonably safe to conduct.^[S5] That conclusion is what carries across the boundary. The data themselves do not predict what will happen in patients, and running the studies well does not remove clinical risk; it establishes the exposures at which effects were seen in the species tested, which is what the starting dose and the monitoring plan are built from.

Absorption, distribution, metabolism and excretion are characterized in the same phase, and the exposure data they produce are what every toxicology finding is interpreted against. They also inform the route and schedule proposed for the clinical trial.

The declaration that has to accompany the studies

One requirement at the boundary is worth knowing precisely, because it is often described inaccurately. For each nonclinical laboratory study in the application, the sponsor must include a statement that the study was conducted in compliance with the good laboratory practice regulation, or, if it was not, a brief statement of the reason for the noncompliance.^[S5] A study conducted outside the regulation is therefore not automatically unusable; what is required is the declaration and the explanation. That distinction matters when deciding which studies need to be placed with a laboratory operating under the regulation and which do not.

Summary

For a sponsor commissioning nonclinical work, the practical content of this subject is short. The clinical regime does not apply to the laboratory running the animal studies. The nonclinical regime applies study by study and is declared in the application. And the thing that crosses the boundary is a conclusion about whether it is reasonably safe to begin dosing humans, supported by the studies.^[S5] Everything else about good clinical practice is the responsibility of the clinical team.