Cited from the European Medicines Agency: http://www.emea.eu.int/Inspections/GCPgeneral.html
"Good Clinical Practice (GCP) is an international
ethical and scientific quality standard for designing, recording and reporting
trials that involve the participation of human subjects. Compliance with this
standard provides public assurance that the rights, safety and well being of
trial subjects are protected, consistent with the principles that have their
origin in the Declaration of Helsinki, and that the
clinical trial data are credible.
Clinical trials included in any marketing authorisation
application in the EU are required to be conducted in accordance with GCP (Directive
2001/83/EC Annex I, as amended by Directive
The GCP guidelines describe some essential documents, documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. Obviously, producing such documents is where you can largely benefit from using Rugloop's electronic data capture capabilities.
To facilitate research according to GCP guidelines when using RugloopII, we are updating the program. The following tools will be integrated:
We are currently in the process of evaluating the measures currently implemented with a local CRO. Based on their comments, modifications could be made to the program. In the very near future, we will be able to provide a GCP compliant version of Rugloop. Obviously, we could support you in further implementation teaming up with your local CRO or backed up by our CRO.
For more information, please contact us