Are Your Clinical Trial Data Collection Methods Compliant?
In Australia, there is no regulatory requirement for your study to collect data using an EDC, however all clinical data must comply with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments, for data collection.
These ICH-GCP guidelines are similar in nature to the FDA Code of Federal Regulation Number 21 Part 11. For electronic data handling systems, these requirements include maintaining a quality system, evidence of secure user access, assurance that the EDC system exhibits traceable data changes (an audit trail), assurance that data is never deleted nor lost, validation of the system and adequate backup of data.
The Mobius Medical EDC is fully compliant with FDA CFR 21 Part 11 and ICH GCP.