measure-repository/Forms/Training/FRM-TRN-001-Administrator-Training-Record.md

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: _________________________________

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Competency Determination

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

Competency achieved on: __________

Specific limitations or supervision requirements: _____________________

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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