When using acopyrighted or validated rating scale(e.g., Hamilton Depression Scale, Visual Analog Pain Scale), anymodification to the original instrument, including preprinting database codes on the CRF, must beapproved by the instrument’s owner or licensing authorityto ensure thevalidity and reliabilityof the instrument are not compromised.
According to theGCDMP (Chapter: CRF Design and Data Collection), validated rating scales are psychometrically tested tools. Any visual or structural modification (such as adding codes, changing layout, or rewording questions) can invalidate prior validation results. Therefore, the CRF designer mustconsult the independent source (copyright holder)for approval anddocument that the validity of the tool remains intact.
Merely consulting statisticians (option B) or verifying database alignment (option D) does not ensure compliance. Thus,Option Censures scientific and regulatory integrity.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 6.1 – Use of Validated Instruments and Rating Scales
ICH E6 (R2) GCP, Section 5.5.3 – Validation of Instruments and Data Capture Tools
FDA Guidance for Industry: Patient-Reported Outcome Measures – Use in Medical Product Development to Support Labeling Claims, Section 4 – Instrument Modification and Validation
