This is a ready-to-use GLP study plan (protocol) template, built directly from the required-element list in 21 CFR 58.120. It is the controlling document for a nonclinical safety study: nothing in the study should happen that this plan, or a signed, dated amendment to it, did not authorize in advance. Replace every <<FILL: ...>> placeholder with your own specifics and route it through your normal study-plan approval before any in-life work begins. A filled specimen excerpt follows. Verify each cited regulation against the current source before you rely on it. This content is general educational reference, not legal or regulatory advice.
Approval
| Field | Entry |
|---|---|
| Study number | <<FILL: e.g. TX-2026-###>> |
| Study title | <<FILL: descriptive title stating the safety objective>> |
| Sponsor | <<FILL: name and address>> |
| Testing facility | <<FILL: name and address>> |
| Study director | <<FILL: name>> |
| Sponsor approval (name, signature, date) | <<FILL>> |
| Study director signature and date | <<FILL>> (must be dated before in-life work begins) |
1. Statement of purpose (58.120(a)(1))
<<FILL: one clear safety objective, e.g. "to evaluate the potential toxicity of Test Article X following 28 consecutive days of oral gavage administration in the rat, with a 14-day recovery period">>. This is a safety study; do not combine it with an efficacy or exploratory objective that would blur GLP scope.
2. Identification of test and control articles (58.120(a)(2))
| Field | Entry |
|---|---|
| Test article name / code / CAS number | <<FILL>> |
| Control/vehicle article | <<FILL>> |
| Batch/lot number(s) to be used | <<FILL>> |
| Reference to the characterization and stability record (58.105) | <<FILL: document reference>> |
3. Sponsor and testing facility (58.120(a)(3))
Both named with addresses in the Approval section above. <<FILL: if the testing facility is a contracted CRO, state the contractual reference and the sponsor's designated monitor>>.
4. Test system (58.120(a)(4), (a)(5))
| Field | Entry |
|---|---|
| Species, strain | <<FILL>> |
| Source / supplier | <<FILL>> |
| Number of animals, sex, group allocation | <<FILL>> |
| Age and body weight range at study start | <<FILL>> |
| Individual identification method | <<FILL: ear tag / tattoo / microchip / cage card, and how uniqueness is confirmed at receipt>> |
| Acclimation period | <<FILL>> |
5. Experimental design, including bias-control methods (58.120(a)(6))
<<FILL: group assignment method (e.g. computer-generated randomization by body weight stratification), blinding where applicable (e.g. blinded pathology read), and how group allocation is documented and verifiable>>.
6. Diet, solvents, emulsifiers, and other materials (58.120(a)(7))
<<FILL: diet source/lot, water source, vehicle/solvent identity and lot, and any other material the test system is exposed to>>.
7. Route of administration and rationale (58.120(a)(8))
| Field | Entry |
|---|---|
| Route | <<FILL>> |
| Rationale | <<FILL: tied to the intended clinical route where feasible, or the scientific reason it differs>> |
8. Dose levels and dosing method/frequency (58.120(a)(9))
| Group | Dose (mg/kg or stated unit) | Method | Frequency |
|---|---|---|---|
<<FILL: Control>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Low>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Mid>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: High>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: Recovery, if applicable>> | <<FILL>> | <<FILL>> | <<FILL>> |
9. Type and frequency of tests, analyses, and measurements (58.120(a)(10))
<<FILL: clinical observations schedule, body weight/food consumption frequency, clinical pathology time points, ophthalmology, ECG, toxicokinetic sampling schedule, terminal procedures and necropsy plan, histopathology tissue list>>.
10. Records to be maintained (58.120(a)(11))
<<FILL: list every raw-data record type this study will generate, e.g. in-life observation sheets, dosing records, body weight/food consumption logs, clinical pathology worksheets and instrument output, necropsy and histopathology records, toxicokinetic bioanalytical data, deviation log>>.
11. Dates (58.120(a)(12))
| Field | Entry |
|---|---|
| Date of sponsor approval | <<FILL>> |
| Date of study director’s dated signature | <<FILL>> (before in-life work begins) |
| Proposed experimental start date | <<FILL>> |
| Proposed experimental completion date | <<FILL>> |
12. Statistical methods (58.120(a)(13))
<<FILL: pre-specified statistical methods and significance thresholds for each endpoint, e.g. one-way ANOVA with Dunnett's test for continuous endpoints, Fisher's exact test for incidence data>>. Statistical methods are fixed here, before the data exist; a method chosen after seeing the results is not a pre-specified method.
Acceptance criteria (protocol level)
- Every element above is present and specific enough that an independent reader could execute the study without asking a clarifying question.
- The study director’s signature is dated before any in-life work begins.
- Dose levels, route, and test system are scientifically justified and traceable to a dose-range-finding or literature basis referenced in the plan.
- Statistical methods are pre-specified per endpoint, not left as “appropriate statistical methods will be applied.”
- Any subsequent change is issued as a signed, dated amendment referencing this study number, never a silent edit.
References
21 CFR 58.120, Protocol. 21 CFR 58.105/58.107/58.113, Test and control article characterization, handling, and mixtures. OECD Principles of Good Laboratory Practice.
Confirm the current version of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Amendment <<FILL: A1>> | <<FILL>> | <<FILL: study director>> | <<FILL: what changed and why>> |
Filled specimen (excerpt)
The following shows sections 1, 4, and 8 completed for an illustrative study. Details are generic and not tied to any real product.
| Field | Entry |
|---|---|
| Study number | TX-2026-031 |
| Statement of purpose | To evaluate the potential toxicity of Test Article X following 28 consecutive days of oral gavage administration in the Sprague-Dawley rat, including a 14-day recovery period, to support first-in-human dosing |
| Species, strain | Rat, Sprague-Dawley |
| Number of animals, sex, group allocation | 80 (40M/40F), 4 dose groups of 10/sex, plus a recovery cohort of 5/sex in control and high-dose groups |
| Dosing | Control 0, Low 10, Mid 50, High 200 mg/kg/day, oral gavage, once daily |
| Study director signature and date | [signed] 2026-02-14, prior to first dose on 2026-02-17 |
Common inspection findings this protocol prevents
- A study plan missing a required 58.120 element, discovered only when an inspector asks for it directly.
- Statistical methods described as “appropriate methods will be used” rather than pre-specified per endpoint.
- A design change made and only reflected in the final report, with no signed, dated amendment showing it was prospective.
- Dose levels or route with no documented scientific rationale.
- The study director’s signature dated after in-life work had already started.
How to adapt this protocol
- Set your study number, sponsor, and testing facility in the approval block.
- Expand section 9 to the full detail your study actually requires; this template gives the structure, not the science.
- Reference the test and control article characterization record (58.105) rather than repeating it here; see the companion Test and Control Article Characterization and Accountability Record.
- Any change after study-director signature goes through a formal amendment, never a silent edit to this document.
- Confirm every regulation cited against the current published version before issue.