TheCase Report Form (CRF) Completion Guidelines (CCGs)are critical documents that guide site staff onhow to accurately and consistently record dataon CRFs across all participating sites, especially in multinational trials.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), one of the key components of the CCGs is alist of acceptable abbreviationsand conventions to be used during CRF entry. This standardization ensures data consistency across languages and countries, reduces ambiguity during data review, and facilitates database design and coding accuracy.
Whiletranslation (A)may be useful for training materials, it is not required for CCGs unless specified by regulatory bodies. OptionsCandDare incorrect because data collection should adhere to standardized terms in English (or the study’s official language) — allowing free use of local languages or arbitrary abbreviations introduces inconsistencies.
Hence,option B—“CCGs must contain the list of acceptable abbreviations to be used in the CRF”— is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: CRF Design and Data Collection, Section 5.3 – CRF Completion Guidelines and Standardization
ICH E6(R2) GCP, Section 5.5.3 – Consistency and Data Recording Requirements
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 – Data Entry Conventions and Documentation
