pediatric-clinical-research/Forms/FRM-004-Training-Record.md

Training Record Form

Form ID	FRM-004	Revision	1.0

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Section 1: Employee Information

Field	Entry
Employee Name
Employee ID
Department
Job Title

Section 2: Training Information

Field	Entry
Training Title
Training Date
Training Duration
Trainer Name
Trainer Qualification

Training Type

• Initial Training
• Retraining
• Refresher
• Procedure Update
• Protocol-Specific Training

Training Category

• Good Clinical Practice (GCP)
• Human Subject Protection
• Pediatric Research Ethics (45 CFR 46 Subpart D)
• Pediatric Safety Requirements (21 CFR 50 Subpart D)
• ICH E11 Pediatric Guidelines
• Pediatric Assent Process
• Parental Permission
• Age-Appropriate Communication
• Child Development
• Child Abuse Recognition and Reporting
• Pediatric Procedures/Techniques
• Study Protocol Training
• Other: ____________

Delivery Method

• Classroom
• On-the-Job
• Self-Study
• Computer-Based
• Simulation/Role-Play
• Other: ____________

Section 3: Training Content

(List topics covered or attach training materials)

Pediatric-Specific Content (if applicable)

• Applicable age groups: [ ] Neonates [ ] Infants [ ] Children [ ] Adolescents
• Special populations covered: ___________________________

Section 4: Assessment

Assessment Method

• Written Test
• Practical Demonstration
• Verbal Assessment
• Observation
• Competency Checklist
• Role-Play/Simulation (for assent discussions)

Assessment Results

Metric	Result
Score (if applicable)
Pass/Fail
Passing Score Required	80% (or per protocol)

Competency Achieved

• Yes - Authorized to perform independently
• No - Requires additional training/supervision

Next Retraining Due Date

Section 5: Signatures

Role	Name	Signature	Date
Trainee
Trainer
Supervisor

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Form FRM-004 Rev 1.0