Data quality in clinical trials: the role of blind review / 药学学报
Acta Pharmaceutica Sinica
; (12): 1498-1501, 2015.
Article
in Zh
| WPRIM
| ID: wpr-320050
Responsible library:
WPRO
ABSTRACT
Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Full text:
1
Database:
WPRIM
Main subject:
Biostatistics
/
Reproducibility of Results
/
Clinical Trials as Topic
/
Databases, Factual
/
Data Accuracy
Type of study:
Guideline
Language:
Zh
Journal:
Acta Pharmaceutica Sinica
Year:
2015
Document type:
Article