RugloopIIę GCP compliance

 

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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.
Requirements for the conduct of clinical trials in Europe including GCP and GMP and inspections of these, have been implemented in the Clinical Trial Directive (Directive 2001/20/EC). (...)

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 2003/63/EC).
(...) 
Europe has adopted the ICH-GCP in July 1996 and this is published in EudraLex Volume 3. ICH has developed unified standards for Europe, US and Japan. Further information on ICH can be found on the ICH site. "

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:

  • a systematic PDF-based set of case logfiles to be used as CRF. These log files are created automatically when the case is closed. As they are protected by password, you have the guarantee that they cannot be tweaked with. They contain the full case information, all events logged, and all timing information in a systematic and structured way. The detailed information is completed with case investigator, case details etc. Here is a screenshot of the generated PDF files




  • a required login for each user to use the system
  • support for study definition / case organization with studies

     

  • obviously, this new functionality will be backed up by detailed Standard Operation procedures and an appropriate user manual. 

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