How are data errors detected?
All CRF images received undergo data entry/data review by at least two different people. As part of the study setup process, legal ranges, field requirements, and other field-level, cross-field, and cross-form edit checks are specified and defined. The mechanism for defining these is built into the DataFax study setup tool and DataFax edit check language.In conjunction with the protocol, the study team reviews the CRFs and identifies edit checks based on the following hierarchy of overall importance and relevance to the study: • Safety: Data items directly relating to participant safety. For example, adverse events, deaths, reactogenicity, etc. • Regulatory: Data items directly related to compliance to the protocol, GCP, and required governmental regulations. • Study Endpoints: Primary and secondary study endpoints, and other critical variables. • Data Flow: Study time lines and required, conditional, and optional forms and visits. • Data Integrity: Legal ranges, required/optional fiel
Related Questions
- If a PHA discovers errors in the data contained in the March Leasing Report and believes it is eligible to apply for reallocated vouchers, can it correct the error and apply for more vouchers?
- If we find errors or omissions in the submitted data during Stage 2, can we add, delete and change data that has not been identified in the ARC/SEER checks?
- How are data errors detected?
