3.6 KiB
3.6 KiB
Internal Audit Checklist - Pediatric Clinical Research
| Form ID | FRM-006 | Revision | 1.0 |
|---|
Audit Information
| Field | Entry |
|---|---|
| Audit Number | |
| Audit Date | |
| Area/Process Audited | |
| Study Protocol (if applicable) | |
| Lead Auditor | |
| Auditee(s) |
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? |
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 |
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
Findings Summary
| Finding # | Type (Critical/Major/Minor) | Description | Regulatory/SOP Reference |
|---|---|---|---|
Positive Observations
(Note any exemplary practices or strengths observed)
Auditor Signatures
| Auditor | Signature | Date |
|---|---|---|
| Lead Auditor | ||
| Co-Auditor (if applicable) |
Form FRM-006 Rev 1.0