InElectronic Data Capture (EDC)systems, free text fields should be usedonly when a predefined list of acceptable responses cannot accommodate the full variability of input data— most notably forAdverse Event (AE) verbatim terms.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), AE verbatim terms are initially entered asfree textby site staff to accurately capture the investigator’s exact medical description of the event. These verbatim terms are latercodedusing standardized dictionaries such asMedDRAduring medical coding, ensuring both flexibility and standardization in reporting.
Conversely, fields such asurine sedimentation rate (A),date of birth (C), andBody Mass Index (D)requirestructured numeric or date formatsto enable validation, range checks, and consistency across datasets. Free text would compromise data integrity, accuracy, and validation efficiency for these structured data elements.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.3 – Use of Free Text and Coded Fields
ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Structure and Validation
MedDRA Introductory Guide, Section 2.3 – Verbatim Entry and Coding Requirements
