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GCP-compliant
data handling in clinical trials
Database:
GCP-Trial
by Gerhard Svolba
Data management in clinical trials is
regulated by the "ICH-Topic E6- Guideline for Good Clinical
Practice", which came into operation on Janaury 17th, 1997. Chapter
5.5 on this regulation is dedicated to the field "Trial Managment, Data
Handling and Record Keeping", the full text of the guideline can be found
under http://www.eudra.org/emea.html (exactly under http://www.eudra.org/humandocs/PDFs/ICH/013595en.pdf), for the most important regulations concerning data
management click here.
For the description of a clinical trial, for
which the GCP-compliant database "GCP-Trial" has been implemented click here.
The database: GCP-Trial
System Description
Data Trailing
Query Handling
Security
Trial Administration
Monitoring Quality Characteristics
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