Clinical trial data validation and user acceptance testing / 药学学报
Acta Pharmaceutica Sinica
; (12): 1480-4, 2015.
Article
in Zh
| WPRIM
| ID: wpr-505011
Responsible library:
WPRO
ABSTRACT
For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Full text:
1
Index:
WPRIM
Type of study:
Clinical_trials
Language:
Zh
Journal:
Acta Pharmaceutica Sinica
Year:
2015
Type:
Article