Telemedicine technologies hosts the database application (CleanWebTM). Telemedicine technologies S.A.S is located at 102-104, avenue Edouard Vaillant, 92100 Boulogne-Billancourt.
Data are entered on a web-based Case Report Form (CRF) through a secure data-entry system. Telemedicine technologies hosts the database application (CleanWebTM) in Paris, France. The data system is set up according to Good Clinical practice (GCP) guidelines, is United States Food and Drug Administration (FDA) compliant (21 CFR part 11) and meets the criteria of European legislation (EU Directive 2001/20/EC/Directive 2005/28/EC, Annex 11, cGMP).
Patient identifiable data
CleanWEB offers the availability to enter Patient Identifiable Data like the last and first name of a patient for practical use in clinic. This provides a clinically orientated database where you can search each patient by his name. Each center can decide if it wishes to use this feature or not, and should inform their Institutional Review Board before enrolling patients. It is the responsibility of the owner of the collected data to justify why such identifying data are needed.
The online database CleanWEB is compliant with the most demanding requirements. This includes the following:
- The Patient Identifiable Data is stored encrypted
- It is saved on a separate server than the medical parameters.
- Differentiation of access rights enables to fully control the access to the Patient Identifiable Data and allow such access only to relevant personnel (within the own site only).
- For other personnel (such as CRA, Data Manager, Project Manager, Principal Investigator) the corresponding data fields will be displayed in the user interface but their value will be set to *****. The term "User Interface" shall also include all dashboards and all printable material that may be generated using CleanWEB.
- Patient Identifiable Data cannot be included in the extraction files.
- CleanWEB provides features to fully delete such data if the patient so wishes.
"Personal Patient Data" are subject to special protection regulations.
CleanWEB is compliant with FDA (For additional information on this compliance, please refer to the following FDA 21 CFR Part 1 – Compliance analysis,) All activities related to development and provision of collaborative software for clinical research and epidemiology have been audited and are certified as complying with the requirements of standard ISO 9001:2008.