Validating electronic source data clinical trials
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.
Contract research organizations (CROs) report they plan to use more data sources than sponsors, and those with the highest trial volumes (greater than 15 trials per year) say they will use more sources of clinical data within the next three years compared to those with lower trial volumes.
While the industry expects to leverage a greater range of patient data in clinical trials, companies in 2017 are primarily managing electronic case report form (e CRF) data in their primary electronic data capture (EDC) system.
From an ethical perspective, clinical data affect treatment decisions, which affect patient health, and the patient population in question is virtually all of the United States and a significant fraction of the rest of the world.
For both of these reasons, clinical data quality and integrity are critical.
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 updated Guideline, issued in the form of a Q&A document, provides that it is the sponsor who is ultimately responsible for validating clinical trial processes that are supported by electronic systems.
In clinical trials settings, the use of electronic systems has proven to be more the standard than the exception.
The updated Guideline clarifies that the sponsor is ultimately responsible for validation of the clinical trial processes which is supported by electronic systems.
The updated Guideline further specifies that the approach to validation should be based on a risk assessment.