pediatric-clinical-research/Forms/FRM-006-Audit-Checklist.md

# Internal Audit Checklist - Pediatric Clinical Research

| Form ID | FRM-006 | Revision | 1.0 |
|---------|---------|----------|-----|

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## Audit Information

| Field | Entry |
|-------|-------|
| Audit Number | |
| Audit Date | |
| Area/Process Audited | |
| Study Protocol (if applicable) | |
| Lead Auditor | |
| Auditee(s) | |

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## General QMS Checklist Items

| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
|---|---------------------|-----------|---------|----------------|
| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
| 3 | Are training records current and complete? | SOP-003 | | |
| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
| 6 | Are CAPAs being completed on time? | SOP-002 | | |
| 7 | Is equipment calibrated and maintained? | | | |
| 8 | Are process controls being followed? | | | |
| 9 | Are quality objectives being monitored? | | | |

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## Pediatric Research-Specific Checklist

| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
|---|---------------------|-----------|---------|----------------|
| 10 | Are informed consent forms IRB-approved and current? | 45 CFR 46 | | |
| 11 | Are assent forms age-appropriate for target population? | 45 CFR 46.408 | | |
| 12 | Is parental permission properly documented? | 21 CFR 50.55 | | |
| 13 | Do consent/assent forms include all required elements? | ICH-GCP 4.8 | | |
| 14 | Are both parent signatures obtained when required? | 45 CFR 46.408(b) | | |
| 15 | Are assent refusals properly documented and respected? | 45 CFR 46.408(a) | | |
| 16 | Is study categorized correctly per 45 CFR 46.404-407? | SOP-PED | | |
| 17 | Are pediatric safety assessments conducted per protocol? | SOP-SAF | | |
| 18 | Are adverse events assessed with pediatric considerations? | ICH E11 | | |
| 19 | Are growth/development parameters monitored? | Protocol | | |
| 20 | Is pediatric dosing calculated and verified correctly? | Protocol | | |
| 21 | Are age-appropriate study materials being used? | SOP-PED | | |
| 22 | Are child-friendly facilities/equipment available? | Site SOPs | | |
| 23 | Is staff trained on pediatric research requirements? | SOP-003 | | |
| 24 | Are child abuse reporting procedures in place? | State Law | | |
| 25 | Is family burden minimized per protocol design? | ICH E11 | | |
| 26 | Are adolescent confidentiality provisions addressed? | HIPAA/State | | |
| 27 | Is DSMB oversight in place if required? | Protocol | | |
| 28 | Are protocol deviations reported per requirements? | ICH-GCP | | |
| 29 | Are serious adverse events reported timely? | 21 CFR 312 | | |
| 30 | Are eligibility criteria properly assessed (age ranges)? | Protocol | | |

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## Study-Specific Items (customize per protocol)

| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
|---|---------------------|-----------|---------|----------------|
| 31 | | | | |
| 32 | | | | |
| 33 | | | | |
| 34 | | | | |
| 35 | | | | |

**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable

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## Findings Summary

| Finding # | Type (Critical/Major/Minor) | Description | Regulatory/SOP Reference |
|-----------|---------------------------|-------------|-------------------------|
| | | | |
| | | | |
| | | | |

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## Positive Observations

*(Note any exemplary practices or strengths observed)*


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## Auditor Signatures

| Auditor | Signature | Date |
|---------|-----------|------|
| Lead Auditor | | |
| Co-Auditor (if applicable) | | |

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*Form FRM-006 Rev 1.0*