Process and method for CDISC-based CRF annotation.
- Author:
Hong-wei WANG
;
Ya-zhong DENG
;
Daniel LIU
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
Databases, Factual;
Documentation;
standards
- From:
Acta Pharmaceutica Sinica
2015;50(11):1474-1479
- CountryChina
- Language:Chinese
-
Abstract:
A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.
