Documentation archiving in clinical data management / 药学学报
Acta Pharmaceutica Sinica
; (12): 1410-1414, 2015.
Article
en Zh
| WPRIM
| ID: wpr-320067
Biblioteca responsable:
WPRO
ABSTRACT
ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Estándares de Referencia
/
Ensayos Clínicos como Asunto
/
Almacenamiento y Recuperación de la Información
/
Curaduría de Datos
/
Métodos
Tipo de estudio:
Clinical_trials
Idioma:
Zh
Revista:
Acta Pharmaceutica Sinica
Año:
2015
Tipo del documento:
Article