FDA Guidance on Clinical Data Standards

Thamar Draper, a 20 year pharma industry veteran with expertise in project management, clinical software implementation and training, and Senior Director of Professional Services at Omnicomm (www.omnicomm.com), talked about FDA guidance on clinical data standards at http://www.bio2devicegroup.org .

The current new draft of FDA Guidance on Standardized Study Data was released February 2012. The actual guidance is expected to come in 2013, NDAs are expected to conform by 2015, and INDs are expected to conform by 2016. This guidance establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format. The guidance guidelines apply to collecting the data in electronic format and to standardization of data itself. Also when moving data around or integrating systems, it should be standardized and validated. Sponsors should consider during planning phase of study which data standards are applicable. Conversion of data to a standardized format at a later date reveals errors that could have been fixed earlier. Therefore, conversion of non standardized data to standardized format at a later date, is discouraged. For clinical and non clinical studies, sponsors should describe in the IND, their plan to submit standardized study data. Draper is a subject matter expert in the areas of EDC systems, clinical data bases and clinical data standards and is actively involved with CDSIC, a global, open, multidisciplinary, non-profit organization that has helped establish these standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

FDA uses certain review tools to review data and they want to review data in the same software. All data collected in the study are required to be submitted. Data validation is required and includes guidance on identifying issues early in data process and use manual inspection for data deficiencies. Technical validation guidance pertains to edit checks to validate the data and Business validation guidance pertains to supporting the data with meaningful analysis and finding errors in the data.

Draper then discussed Omnicomm’s Electronic Data Capture (EDC) and eClinical technologies with standards for Library, Data Collection, Data Exports, and Data Analysis, that can effectively and efficiently help companies comply with FDA guidance while also expediting clinical decisions and submissions. The talk was followed by Q&A.


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