The pilot project is being run by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and is aimed at testing a new way of entering patient data into electronic media - which allows real-time data validation checks - instead of currently used in paper-based CRFs.
"This pilot will test the ability of a new data format to support all review activity, which our current submission format is incapable of doing," the FDA said.
The new format is based on the operational data model (ODM) developed by the Clinical Data Interchange Standards Consortium, the body which sets industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data.
The project, if successful, will allow the agency to routinely accept CRFs from studies that use electronic data capture (EDC) in ODM format in marketing applications already submitted in electronic format.
Under existing regulations, drug companies must provide CRFs with a drug marketing application and since 1997, the FDA has accepted eCRFs - in the form of a PDF document - instead of paper.
But according to the agency, PDF-based CRFs from clinical trials that use electronic data capture (EDC) are not "ideal".
As the use of EDC in clinical trials is escalating, CDER and CBER are now interested in adopting a new, standard format that can replace the PDF documents and that can reliably provide all three components of the CRF in an electronic format - data, metadata and audit trail.
The agency said that only five clinical trial sponsors are needed for the pilot and it will choose participants based on their previous experience submitting CRFs in accordance to existing guidelines.
Interested CROs must apply by the beginning of September.
The agency is also accepting general comments on the subject.