Validating electronic source data clinical trials
Over the next three years, 93% of respondents aim to use electronic patient reported outcomes (e PROs) and electronic clinical outcomes assessment (e COA) as sources, but today such data make up only 4% of the total data managed in EDC.
However the updated Guideline provides that different requirements will apply for the validation or qualification of electronic systems where the sponsor changes or adds functionalities to the system.
The systems are used for different purposes including data collection, data management, safety data management and evaluation, treatment allocations.
A considerable number of electronic case report forms and applications for instance collection of patient related outcome or clinical outcome assessment are provided by, or purchased from, vendors and customised to varying degrees.
The volume and diversity of data sources used in clinical trials are expected to skyrocket for the rest of the decade, according to new research from Tufts Center for the Study of Drug Development.
In the second report from the , 97% of companies say they will increase their use of at least one clinical data source to make faster, more accurate decisions during trials.