More Clarity Needed on FDA eSource Trial Data Draft Guidance

More Clarity Needed on FDA eSource Trial Data Draft Guidance

April 1st, 2013 // 8:15 pm @

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April 1, 2013

There are numerous calls among clinical trial stakeholders for more clarity on FDA draft guidance that tries to reduce pitfalls in switching to electronic source data for future clinical investigations.

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The draft guidance was released in 2011 and is called Electronic Source Data in Clinical Investigations. The aim of this guidance is to give CROs, sponsors and other clinical investigators more guidance on how to capture/review/archive source data in clinical investigations that are regulated by FDA. It also is trying to cut down on duplicate data, cut down on transcription errors, and to promote more real time access to clinical trial data.

While we have seen some support for the draft guidance, some stakeholders, such as ACRO, have voiced concern that many clinical sites are being quizzed during clinical FDA inspections about data system validation. That is why industry stakeholders would like to get FDA’s perspective on if it is needed for CROs to give FDA some type of validation summary with the systems provided. This would possibly help to answer some basic questions regarding validation, back ups and security protocols. This type of summary could help clinical sites to respond more efficiently to these questions from FDAers.

Drug company Medimmune has voiced support for this request, noting that it could be helpful if they could understand FDA’s requirements and expectations to access electronic systems during an audit. Many of these systems are run with strict security protocols and require training to be used.

Medimmune also noted that the draft guidance from FDA can be confusing when you are trying to grasp if it intends to set expectations for an electronic case report form (eCRF), regardless of the source of data, or for an electronic source of data.

We also are hearing there is more clarity needed on expectations for future electronic source data and whether it is only important if there is direct and clear transmitting to the eCRF, or if they are applicable at all times.

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