PIL Standard Condition 20 Explained

The licence holder shall maintain a record of all animals on which procedures have been carried out, including details of supervision and declarations of competence by the project licence holder as appropriate. This record shall be retained for at least five years and shall, on request, be submitted to the Secretary of State or made available to an Inspector.
(View the Official list of Personal Licence Standard Conditions.)

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What does this mean in practice?

You should maintain accurate, clear, and accessible records relating to your animal research activities. Good record keeping supports animal welfare, legal compliance, scientific integrity, and the ability to review and refine procedures over time.

Examples of records that should be maintained include:

Breeding records

These may include:

• Parentage information
• Litters born
• Litter sizes and losses
• Breeding performance
• Genotyping outcomes where applicable

Records of defects or abnormalities

Any defects or unexpected findings observed in research animals should be recorded. This is particularly important in breeding colonies but also applies to animals supplied from external breeders.

Examples may include:

• Missing or abnormally small eyes
• Unexpected coat colour or patterning
• Curvature of the spine or tail
• Doming of the head
• Developmental abnormalities

Recording these findings can help identify:

• Genetic drift
• Spontaneous mutations
• Colony management issues
• Environmental concerns affecting the colony

Where appropriate, findings should also be reported to the animal supplier to support colony management and welfare monitoring.

Animal experience and procedural history

Records should clearly document the procedures animals have undergone and their overall experience throughout the study. These records support severity assessment and retrospective review of welfare impacts.

For specially protected species such as dogs, cats, and non-human primates, an individual history record must be maintained. This should include:

• Permanent identification details
• Date and place of birth where known
• Breeding status
• Veterinary history
• Procedural history
• Social history

For non-human primates, records must also state whether the animal is the offspring of captive-bred primates.

Welfare scoring and monitoring records

Welfare assessments and scoring records should be maintained in a clear and interpretable format.

These records may be required:

• As part of protocol controls
• As evidence of good practice
• During review of unexpected adverse effects
• During investigation of spontaneous deaths or SC18 reports

Good welfare records support the culture of care by demonstrating active monitoring and management of animal welfare. They may also provide useful scientific information, such as identifying disease progression trends, opportunities for refinement, earlier humane endpoints, or previously unrecognised adverse effects.

Procedure and surgical records

Records of procedures and surgeries should be retained, including anaesthetic and monitoring records where applicable.

These records may include:

• Anaesthetic monitoring sheets
• Surgical notes
• Recovery observations
• Post-operative care records

For special species, these records should also form part of the individual history file.

Personal procedure logs

You should maintain a personal record or log of the procedures you perform.

This should include:

• Dates
• Species and strain
• Animal IDs or cage IDs
• Procedures performed
• Relevant procedural details, such as routes or volumes administered
• The Project Licence under which the work was conducted
• Any associated Experimental Plans where used

These records may be reviewed during your five-year Personal Licence review to ensure your licence authorities, competencies, and species permissions remain appropriate.

Training and competency records

Training and competency records should be maintained centrally so that Named Persons and relevant staff can review them when required.

You should also have access to your own records so that you can:

• Track current competencies
• Identify skills gaps
• Monitor refresher requirements
• Arrange additional training or competency assessments where needed

Maintaining accurate records is an essential part of responsible animal research practice and demonstrates both good scientific practice and compliance with ASPA.

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How do I comply with PIL Standard Condition 20?

You can fulfil this Standard Condition by implementing reliable systems to support accurate, accessible, and consistent record keeping.

One effective approach is the use of shared electronic procedure records, such as centralised spreadsheets or database systems, which allow both individual users and the Project Licence Holder to review, sort, and monitor animal and procedural data efficiently.

Paper records, such as cage cards and room-based monitoring sheets, remain important for day-to-day animal care and quick access to information within animal areas. However, where possible, important records should also be transferred to secure electronic systems.

Electronic record systems provide several advantages, including:

• Easier review and oversight
• Improved traceability and audit trails
• Secure backup of information
• Reduced risk of records being lost or damaged

Paper documents can be accidentally misplaced, disposed of, or damaged through incidents such as fire, flooding, or general wear over time.

Where available, local colony management or breeding systems should also be used to maintain breeding records and pedigree information.

Carefully recording information such as breeding performance, defects or abnormalities, genetic trends, and colony lineage can enhance colony management and help identify issues like genetic drift, spontaneous mutations, or inherited defects within breeding lines.

• Breeding performance
• Defects or abnormalities
• Genetic trends
• Colony lineage

can help support better colony management and identify issues such as genetic drift, spontaneous mutations, or inherited defects within breeding lines.

Maintaining detailed breeding and pedigree records may also support decisions relating to:

• Backcrossing strategies
• Colony refinement
• Restocking from cryopreserved lines
• Long-term colony health and sustainability

Good record keeping supports animal welfare, scientific quality, traceability, and regulatory compliance across all aspects of animal research.

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What resources are available to support me?

LASA has produced guidance and recommendations on record keeping for Personal Licence holders. These resources should be reviewed by all licence holders to help identify gaps in current record-keeping practices and determine whether more effective systems or processes could be introduced.

The guidance can support improvements in:

• Procedure records
• Welfare monitoring documentation
• Breeding and colony management records
• Training and competency records
• Traceability and audit trails
• Data storage and retention practices

Reviewing these recommendations regularly can help ensure your records remain clear, compliant, accessible, and useful for both animal welfare management and regulatory oversight.

See below for a record-keeping matrix outlining mandatory requirements versus recommended good practice.

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What happens if I don’t comply with PIL Standard Condition 20?

During audits, PPL SC18 investigations, or Personal Licence reviews, you may be asked to produce your records. Failure to maintain records, or to keep them in an accessible and understandable format, may result in retraining or other corrective actions.

In more serious cases, poor or missing records could contribute to suspension or revocation of a Personal Licence, as these records provide evidence that you are complying with multiple other licence conditions and welfare requirements.

Some record-keeping failures may also affect the Establishment Licence Holder (PELh) or Project Licence Holder (PPLh), due to the close relationship between procedural records, welfare monitoring, training records, and compliance systems.

As a result, the impact of poor record keeping can extend beyond the individual licence holder and, in serious situations, may contribute to wider compliance concerns within the establishment, including increased regulatory oversight or special measures.

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How does ASRU assess compliance with PIL Standard Condition 20?

ASRU assesses compliance with PIL Standard Condition 20 by reviewing how Personal Licence holders maintain records of regulated procedures carried out on animals, including records relating to supervision and competency declarations where required.

During an inspection, ASRU may review Standard Operating Procedures and local systems used for recording procedures and maintaining procedural records. Inspectors may also examine examples of procedure logs, animal records, supervision records, and competency documentation to confirm that records are being completed accurately and retained appropriately.

Compliance may additionally be assessed through discussions with Personal Licence holders to confirm that they understand their responsibilities for maintaining clear, accurate, and accessible records of regulated procedures and associated supervision arrangements.

ASRU may also assess whether records are retained for the required minimum period and can be produced promptly when requested during inspections, audits, or investigations.

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How do I know if I am complying with PIL Standard Condition 20?

You can be confident that you are fulfilling this Standard Condition if you maintain accurate, clear, and easy-to-review records of the procedures you perform.

Your records should be organised, interpretable, and readily accessible if requested during:

• An ASRU audit or inspection
• A PPL SC18 investigation
• Your five-year Personal Licence review

You should also feel confident presenting these records alongside your training and competency records as evidence of:

• Appropriate licence use
• Ongoing procedural activity
• Current competency and authority
• Compliance with licence conditions and local requirements

Good records should allow another person to clearly understand what procedures were performed, when they were carried out, which animals were involved, and under which licence authority the work took place.