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Animal Research Report Template (ARRIVE 2.0)

In vivo study report covering ARRIVE 2.0 Essential 10 and Recommended Set: design, sample size, blinding, welfare, results

Наукові дослідженняПовнийARRIVE 2.0animalstudymath

Як використовувати: Use when reporting any experiment on live animals for publication or internal review. Fill the Essential 10 first, especially the experimental unit, sample size and exclusions. Main pitfall: missing animal counts at each stage or unreported exclusions, which make results impossible to assess.

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Animal Research Report: [Short title of the study]

Report template for in vivo research using animals. The sections cover the topics of the ARRIVE 2.0 guidelines, both the Essential 10 and the Recommended Set, arranged in manuscript order and written in original words for this collection. Use it with the official ARRIVE checklist and explanation document from arriveguidelines.org and with your institution's animal welfare requirements. This is a reporting format, not veterinary, ethical or statistical advice. Replace every [bracketed] value and every row marked Example.

Document control

FieldValue
Document ID[ANI-STUDY-001]
Project licence / protocol[Licence or IACUC protocol number]
Ethics committee[Animal welfare body / IACUC name and approval number]
Preregistration[Registry and identifier or "not registered"]
Version[0.1]
Status[Draft / In review / Approved]
Owner[@principal-investigator]
Approvers[@named-veterinary-surgeon], [@statistician]
Last updatedYYYY-MM-DD
Classification[Confidential until publication]

Approvals

RoleNameDecisionDate
Principal investigator[@name][Approved]YYYY-MM-DD
Named veterinary surgeon / attending veterinarian[@name][Reviewed welfare sections]YYYY-MM-DD
Statistician[@name][Approved]YYYY-MM-DD

Revision history

VersionDateAuthorChange summary
0.1YYYY-MM-DD[@name]First draft after unblinding
0.2YYYY-MM-DD[@name]Example: Added litter as random effect after statistical review
1.0YYYY-MM-DD[@name]Approved for submission

Contents

1. Title and abstract

The title names the species and the main intervention; the abstract summarises objectives, species, methods, results and conclusions.

Title: [Effect of [intervention] on [outcome] in [species and strain, sex] model of [condition]]

HeadingContent
Objective[Research question]
AnimalsExample: 48 male and female C57BL/6J mice, 10-12 weeks old
Design[Randomised, blinded, number of groups, experimental unit]
Main outcome[Primary outcome and time point]
Results[Effect size with 95% CI for the primary outcome]
Conclusions[Proportionate to the evidence]

2. Introduction

The introduction justifies the research and the use of animals.

2.1 Background (ARRIVE 12)

[Summarise the scientific background and the gap. Explain why animals were needed, why this species and model were chosen and how the model relates to the human or animal condition of interest.]

2.2 Objectives (ARRIVE 13)

IDObjective or hypothesisType
OBJ-01Example: Treatment with [compound] at 10 mg/kg reduces infarct volume at 24 hours compared with vehiclePrimary, confirmatory
OBJ-02[Secondary objective]Secondary
OBJ-03[Exploratory question]Exploratory

3. Methods

This section describes the ethical framework, design and procedures.

3.1 Ethical statement (ARRIVE 14)

[Name the ethical review body, the approval or licence number and the legislation or guidelines followed. If no approval was required, explain why.]

3.2 Study design (ARRIVE 1)

ItemDetail
Experiment ID[EXP-01]
GroupsExample: Vehicle; compound 3 mg/kg; compound 10 mg/kg; sham surgery
Control groups[Vehicle, sham, positive control]
Experimental unit[Single animal / cage / litter] and rationale
Design type[Completely randomised / randomised block / crossover]

The design is summarised below.

3.3 Sample size (ARRIVE 2)

For a two-group comparison of means, the number per group is:

n=2 σ2 (z1−α/2+z1−β)2Δ2n = \frac{2\,\sigma^{2}\,\left(z_{1-\alpha/2} + z_{1-\beta}\right)^{2}}{\Delta^{2}}

Example: Expected difference Δ=20 mm3\Delta = 20\ \text{mm}^3, standard deviation σ=15 mm3\sigma = 15\ \text{mm}^3 from pilot data, two-sided α=0.05\alpha = 0.05 and 80% power give n=2×225×(1.96+0.84)2/400≈8.8n = 2 \times 225 \times (1.96 + 0.84)^{2} / 400 \approx 8.8, rounded up to 9; 12 per group were used to allow for an expected 20% surgical mortality.

When a power calculation is not possible, for example in exploratory work, the resource equation gives an upper bound:

E=N−T,10≤E≤20E = N - T, \qquad 10 \le E \le 20

where NN is the total number of experimental units and TT the number of treatment groups.

GroupAnimals allocatedAnimals analysed
[Vehicle][12][10]
[Low dose][12][11]
[Total][48][42]

3.4 Inclusion and exclusion criteria (ARRIVE 3)

CriterionTypeSet a priori?
Example: Cerebral blood flow drop below 70% of baseline during occlusionInclusionYes
Death before outcome assessmentExclusionYes
[Criterion][Inclusion / Exclusion][Yes / No]
Animal IDGroupExcluded at stageReason
[M-017][Vehicle][Surgery][Haemorrhage]

3.5 Randomisation (ARRIVE 4)

[Say whether randomisation was used to allocate units to groups, the method used to generate the sequence (for example a computer random number generator, blocked by cage or batch), and how confounders such as order of treatment and measurement or cage location were controlled.]

Example: Animals were allocated to the four groups in blocks of four using a sequence generated in R (set.seed(20250314), sample()) by a colleague not involved in surgery. Each block was one surgery day, so every group was represented on every day. Cage positions on the rack and the order of outcome assessment followed the same random sequence.

Potential confounderControl method
Order of surgery[Randomised within day]
Cage position[Randomised rack location]
Operator[Single surgeon for all animals / balanced across groups]
Batch of compound[Single batch, lot number]

3.6 Blinding (ARRIVE 5)

StageWas the person aware of group?How blinding was achieved
Allocation[Yes / No][Method]
Conduct of experiment[Yes / No]Example: Solutions coded A to D by a colleague not involved in surgery
Outcome assessment[Yes / No][Coded image files]
Data analysis[Yes / No][Code broken after analysis was locked]

3.7 Outcome measures (ARRIVE 6)

IDOutcomeDefinition and methodTime pointPrimary?
OUT-01Example: Infarct volumeTTC staining, volumetric analysis corrected for oedema24 hYes
OUT-02[Neurological score][Scale and reference][24 h, 72 h]No
OUT-03[Body weight][Daily weighing][Daily]No

3.8 Statistical methods (ARRIVE 7)

ItemMethod
Primary analysisExample: One-way ANOVA with Dunnett's comparison against vehicle
Assumption checks[Residual plots; Shapiro-Wilk; transformations used]
Clustering[Litter or cage as random effect]
Effect measure[Mean difference with 95% CI]
Software[Name and version]

3.9 Experimental animals (ARRIVE 8)

ItemDetail
Species and strainExample: Mus musculus, C57BL/6J
Sex[Male and female; rationale if single sex]
Age and weight[10-12 weeks; 22-28 g at start]
Source[Supplier or in-house colony]
Genetic modification[Allele nomenclature, background, generation]
Health status[Specific pathogen free; health monitoring report]
Previous procedures[None / describe]

3.10 Experimental procedures (ARRIVE 9)

ProcedureWhat and howWhenWhereWhy
Anaesthesia[Agent, dose, route, monitoring][Day 0][Surgery room][Surgery]
InterventionExample: [Compound] 10 mg/kg intraperitoneally in 5 ml/kg saline30 min after occlusionHome cageTest hypothesis
Analgesia[Agent, dose, frequency][Peri-operative][Location][Welfare]
Euthanasia[Method][24 h][Location][End point]

3.11 Housing and husbandry (ARRIVE 15)

ConditionDetail
Housing[Individually ventilated cages, animals per cage]
Bedding and enrichment[Type]
Light cycleExample: 12:12 h light-dark, lights on 07:00
Temperature and humidity[Range]
Diet and water[Diet name, ad libitum]

3.12 Animal care and monitoring (ARRIVE 16)

[Describe steps to reduce pain, suffering and distress; the expected and unexpected adverse events and how they were managed; and the humane end points with their criteria and the frequency of monitoring.]

Humane end pointCriterionMonitoring frequencyAction
Weight lossExample: More than 20% of baselineDailyEuthanasia
[Clinical score][Threshold][Frequency][Action]

4. Results (ARRIVE 10)

This section reports the numbers analysed and the outcomes.

4.1 Animals analysed

GroupAllocatedExcludedAnalysed
[Vehicle][12][2][10]
[Low dose][12][1][11]
[High dose][12][2][10]
[Sham][12][1][11]

4.2 Outcomes

OutcomeGroupnMean (SD)Difference vs control (95% CI)
OUT-01Vehicle[10]Example: 62.4 (14.8)Reference
OUT-01High dose[10]41.9 (13.2)-20.5 (-33.7 to -7.3)
[Outcome][Group][n][Value][Value]

4.3 Adverse events

[Report all adverse events in each group, any modifications to procedures to reduce them, and animals reaching humane end points.]

EventVehicleLow doseHigh doseShamAction taken
Death during surgery[1][0][1][0]Example: Anaesthetic depth monitoring tightened from day 3
Humane end point reached[1][1][1][0]Euthanised per protocol
[Other event][n][n][n][n][Action]

5. Discussion

The discussion interprets the findings and their relevance.

5.1 Interpretation and scientific implications (ARRIVE 17)

[Interpret the results in light of the objectives and the literature. Discuss limitations, including sources of bias, limits of the model and imprecision. Describe any implications for replacement, refinement or reduction (the 3Rs).]

Example: A single dose of [compound] given 30 minutes after occlusion reduced infarct volume by about a third compared with vehicle. The estimate is imprecise, and the study was powered for one dose and one time point only. Efficacy in aged animals or animals with comorbidities, which better reflect the clinical population, was not tested.

5.2 Generalisability and translation (ARRIVE 18)

[Comment on whether, and how, the findings are likely to apply to other species, strains, sexes or experimental conditions, and their relevance to human biology.]

6. Other information

These items support transparency and reuse.

6.1 Protocol registration (ARRIVE 19)

[State whether a protocol, including the research question, key design features and analysis plan, was prepared before the study and whether and where it was registered, for example preclinicaltrials.eu or OSF.]

6.2 Data access (ARRIVE 20)

[Statement describing whether and where the study data are available, for example a public repository with a persistent identifier.]

6.3 Declaration of interests (ARRIVE 21)

ItemDetail
Competing interests[Statement for each author, or "none"]
Funding[Funder, grant number]
Role of funder[Role in design, analysis, publication, or none]

7. Appendices

Supporting material for reviewers:

AppendixContent
ACompleted ARRIVE 2.0 checklist with page numbers
BIndividual animal data and exclusion log
CWelfare scoring sheet and humane end-point criteria
DGlossary: [3Rs replacement, reduction, refinement; IACUC institutional animal care and use committee; SPF specific pathogen free]

Standard and licence note

Based on the ARRIVE guidelines 2.0: Percie du Sert N, Hurst V, Ahluwalia A, et al., The ARRIVE guidelines 2.0: updated guidelines for reporting animal research (PLoS Biol 2020;18(7):e3000410), https://arriveguidelines.org. The guidelines are published open access under a Creative Commons Attribution licence; this template uses their item topics and numbering only, paraphrased in original text, and reproduces no checklist wording. Use the official checklist and the explanation and elaboration document when submitting. This is a reporting format, not veterinary, ethical or statistical advice; follow your national legislation and institutional animal welfare policy. Template licence: MIT.

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