Validation and Data Integrity in eClinical Platforms – A Concept Paper by the ISPE GAMP CoP
Clinical trials are conducted and managed as an independent project even if several trials investigate the same Investigational Medicinal Product (IMP). Each clinical trial is different as each address different parts of the development cycle or varying product indications or endpoints. Trial projects vary greatly in terms of duration, number of patients to be recruited, the pace of enrollment and spread of geographic locations.
The Concept Paper addresses how eClinical platforms, for trial specific setups, may be built from various integrated technologies and tools designed to be utilized in clinical trials. As well as these platforms work together to share data, eliminate duplication of activities and streamline the use of multiple technologies for the end user. The Concept Paper was produced by members of the GAMP Global Steering Committee R&D and Clinical Systems Special Interest Groups.
An eClinical platform is defined as a pre-existing environment of integrated computerized systems that can be adapted to support the conduct of a clinical trial by utilizing existing, validated functionality and processes.
Typical platforms include Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTFM), statistical systems as well as safety systems and others. Individual components of the eClinical platform may require set-up or configuration to meet the requirement of the individual clinical trial.
The tightly integrated flow of data between multiple systems requires additional controls to ensure data integrity during the data creation and collection stage of the overall clinical data lifecycle. A risk-based approach to validation should not only be applied to individual systems but also taken upward to the next level. A holistic risk assessment of the eClinical platform, including data flows across integrated systems, should be performed with additional controls added as necessary.
Go here to read the complete concept paper.