Key factors in design of case report form.
- Author:
Hai-jun FU
;
Xiao-xia LUO
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
standards;
Data Collection;
standards;
Documentation;
standards;
Research Design;
standards
- From:
Acta Pharmaceutica Sinica
2015;50(11):1452-1455
- CountryChina
- Language:Chinese
-
Abstract:
Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
