# Administrator Training Record

| Form ID | FRM-TRN-001 |
|---------|-------------|
| Form Title | Administrator Training Record |
| Version | 1.0 |
| Effective Date | [DATE] |

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## Trainee Information

| Field | Information |
|-------|-------------|
| Name | |
| Employee/Study ID | |
| Department/Site | |
| Job Title/Role | |
| Education Level | |
| Clinical Credentials (if applicable) | |

## Training Session Information

| Field | Information |
|-------|-------------|
| Measure Name | |
| Measure Version | |
| Measure Type | ☐ PRO  ☐ ClinRO  ☐ ObsRO  ☐ PerfO |
| Training Date | |
| Training Duration | |
| Training Location | ☐ In-Person  ☐ Virtual  ☐ Self-Study |
| Training Materials Version | |

## Trainer Information

| Field | Information |
|-------|-------------|
| Trainer Name | |
| Trainer Qualifications | |
| Trainer Certification (if required) | |

## Training Content Covered

### General Training Topics

☐ PRO/ClinRO/ObsRO/PerfO concepts and definitions
☐ FDA PRO Guidance principles
☐ Standardized administration techniques
☐ Avoiding interviewer bias and response influence
☐ Handling participant questions appropriately
☐ Missing data minimization strategies
☐ Data quality and integrity requirements
☐ Good Clinical Practice (GCP) principles
☐ Informed consent and research ethics
☐ Privacy and confidentiality (HIPAA)

### Measure-Specific Topics

☐ Measure purpose and theoretical construct
☐ Target population and intended use
☐ Item content and response format
☐ Recall period specification
☐ Administration instructions (verbatim)
☐ Timing and scheduling requirements
☐ Scoring procedures and calculations
☐ Score interpretation and clinical meaning
☐ Handling incomplete responses
☐ Common administration errors to avoid
☐ Special considerations for this measure

### Additional Training (check all that apply)

☐ Electronic administration (eCOA platform training)
☐ Paper backup procedures
☐ Translation and language-specific considerations
☐ Cultural adaptation considerations
☐ Safety procedures (for PerfO)
☐ Equipment operation (for PerfO)
☐ Inter-rater reliability procedures (for ClinRO)

## Practical Components Completed

☐ Review of measure items and instructions
☐ Observation of demonstration administration
☐ Mock administration with standardized participant
☐ Role-play practice with feedback
☐ Video review of administration technique
☐ Inter-rater reliability exercise (for ClinRO)
☐ Scoring practice with sample data
☐ eCOA system navigation practice

## Knowledge Assessment

### Written Test

Test Version: __________

Number of Questions: __________

Score: __________ / __________     Percentage: __________%

☐ Pass (≥80%)     ☐ Fail (<80%)

If failed: Remediation plan and retest date: _________________________

### Practical Assessment

☐ Pass - Demonstrated competent administration
☐ Fail - Additional training needed

Specific areas needing improvement: _________________________________
________________________________________________________________
________________________________________________________________

## Competency Determination

☐ **COMPETENT** - May administer measure independently
☐ **NOT YET COMPETENT** - Additional training/supervision required

Competency achieved on: __________

Specific limitations or supervision requirements: _____________________
________________________________________________________________

## Copyright Holder Certification (if applicable)

Certification Required: ☐ Yes  ☐ No

If Yes:
Certification Program: ___________________________________________
Certification Number: ___________________________________________
Certification Date: __________
Expiration Date: __________
Certificate on file: ☐ Yes  ☐ No

## Study/Protocol Assignment

This training qualifies the administrator for the following studies/protocols:

| Protocol Number | Protocol Title | Principal Investigator |
|----------------|----------------|----------------------|
| | | |
| | | |
| | | |

## Signatures

**I certify that I have completed the training described above and understand the requirements for administering this outcome measure. I will follow all procedures as trained and seek guidance when uncertain.**

Trainee Signature: ______________________    Date: __________

**I certify that the trainee named above has successfully completed training and demonstrated competence in administering this outcome measure.**

Trainer Signature: ______________________    Date: __________

**I approve this individual to independently administer this outcome measure in the assigned studies/protocols.**

Supervisor Signature: ______________________    Date: __________

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## Retraining/Recertification Record

| Date | Reason for Retraining | Trainer | Result |
|------|----------------------|---------|--------|
| | ☐ Measure update  ☐ Performance issue  ☐ Extended absence  ☐ Certification renewal  ☐ Other: _____ | | ☐ Pass  ☐ Fail |
| | | | |
| | | | |

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## Distribution

Original: Personnel Training File
Copy: Study File
Copy: Training Database

**Record Retention:** Duration of employment + 3 years minimum; per study protocol requirements

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**Related Documents:**
- SOP-GEN-002: Training and Competence for Measure Administration
- SOP-ADM-001: Clinical Outcome Measure Administration
- FRM-TRN-002: Competency Assessment Form