ACRO Calls for Clarity on FDA Draft Guidance on eSource Trial Data
The draft guidance from 2011, called “Electronic Source Data in Clinical Investigations,” aims to provide CROs, sponsors and other investigators with guidance on how to capture, review and archive source data in FDA-regulated clinical investigations. It also aims to help eliminate duplicate data, reduce transcription errors, promote real-time access to data. The comment period for the draft guidance closed on Tuesday.
ACRO offers its support for the draft guidance but notes in its comment that some clinical sites are being asked during FDA inspections about the validation of data systems they are using.
“We would appreciate the Agency’s perspective as to whether it is necessary for CROs to consider supplying some type of validation summary with the systems we provide, to answer the basic questions surrounding validation, security controls, backups, etc. to help the sites to be able to respond to those regulatory questions,” ACRO executive director Douglas Peddicord writes.
Drugmaker MedImmune echoed that request, saying that it “might be helpful to understand FDA’s requirements/expectations” in accessing electronic systems during an inspection because many systems are governed by security policies and require certain training to use them.
MedImmune also notes that the draft is “at times confusing when trying to understand whether it is setting out expectations for an [electronic case report form (eCRF)] (irrespective of data source) or for electronic source data.”
Further clarity is necessary on the expectations for electronic source data and whether it is “only relevant if there is a direct transmittal to the eCRF or are generally applicable in all circumstances,” the company adds.
Access to Data
The guidance also “appears to suggest” that all originators of data should have access to what is input into the data systems, including labs and subjects, but ACRO says “it is not clear why the originators would need to be able to do this, and it is unlikely that originators would do their own check to ensure transmission is accurate.”
Subjects reviewing prior responses in a patient diary also may cause bias in future responses, ACRO says.
The clinical trials services unit of the UK's Oxford University also took issue with “a number of problems” in the draft related to when hospitals upgrade their EHR (electronic health record) systems periodically and do not make old data available.
“In these circumstances it would seem appropriate for an unmodified copy of the data that are transmitted to be stored (with appropriate metadata),” Oxford says. “This would mirror the ‘certified copy’ approach used for paper sources, with an electronic signature applied appropriately.”
