When using a copyrighted or validated rating scale (e.g., Hamilton Depression Scale, Visual Analog Pain Scale), any modification to the original instrument, including preprinting database codes on the CRF, must be approved by the instrument's owner or licensing authority to ensure the validity and reliability of the instrument are not compromised.
According to the GCDMP (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 must consult the independent source (copyright holder) for approval and document 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 C ensures 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