FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions

Posted 07 November 2017 | By Michael Mezher 

FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions

The US Food and Drug Administration (FDA) on Tuesday opened for public consultation a proposed analysis data reviewer's guide (ADRG) template developed as part of a collaboration with the Pharmaceutical Users Software Exchange (PhUSE).

FDA says it is seeking comments from stakeholders to inform its review of the proposed template to determine whether the agency will recommend the template as is, or with modifications, for regulatory submissions involving study data.

According to FDA, preparing an ADRG is "recommended as an important part of a standards-compliant analysis data submission for clinical trials. The ADRG provides FDA reviewers with context for analysis datasets and terminology, received as part of a regulatory product submission."

While FDA does not yet recommend a specific ADRG template, the agency directs sponsors to the PhUSE ADRG template in its Study Data Technical Conformance Guide.

"The ADRG purposefully duplicates limited information found in other submission documents (e.g., the protocol, statistical analysis plan (SAP), clinical study report, define.xml) in order to provide FDA reviewers with a single point of orientation to the analysis datasets," FDA explains.

The current 1.1 version of the ADRG was released in January 2015, and includes the template, a completion guideline and two samples of completed ADRGs.

When submitting an ADRG for a clinical study, FDA says the document should be formatted as a PDF titled 'adrg.pdf' and placed with the analysis data in Module 5 of the electronic common technical document (eCTD).

Federal Register Notice

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