|
Experience, Expertise, Excellence |
|
Electronic Submission Datasets |
|
The Electronic Records; Electronic Signatures Regulations (21 CFR Part 11) provides FDA the authority to identify types of submissions that the agency will accept in electronic form. General guidelines for how to proceed with electronic submissions have been documented in the Guidance for Industry document Providing Regulatory Submissions in Electronic Format- General Considerations (CDER and CBER, 1999). The FDA plans to issue a series of guidance documents that will focus on specific submission types, the first of which, Providing Regulatory Submissions in Electronic Format – NDAs (CDER) was issued in January 1999. Format and Organization “Part 11” requires that datasets presented in electronic format provide an accurate and complete copy of the data suitable for inspection, review, and copying. Currently, the FDA accepts datasets in SAS® XPORT transport format (Version 5 SAS® transport file). This is an open format in that its specifications are in the public domain and data can be translated to/from the format without the use of vendor specific programs. SAS® CPORT transport format is not supported by the FDA sinceit is proprietary in that it requires the SAS® software for translation.
SAS® files are processed to and from XPORT format by PROC XCOPY in SAS® version 5 and by the XPORT engine in SAS® versions 6 and above. Further details of the XPORT format are documented in SAS® Technical Report P-195.
The organization and dataset elements should be discussed with the review division prior to submission. The uncompressed transport files should be less than 25 MB per file and should be accompanied by documentation. The documentation should consist of a dataset definition table followed by an individual table for each dataset containing an organized listing of variable names, descriptive labels, data types, and codes.
General Considerations Each animal should be identified with a unique number that, along with treatment group and sex, should be included in all datasets. Each record of the dataset should contain a single observation for an individual animal (eg. multiple clinical chemistry endpoints for an individual animal should be represented in the dataset as multiple records for that animal rather than a single record with multiple variables). Variable names and codes should be consistent across all studies and, if codes are used (eg. organ weight codes), then an additional text name variable should be included.
The BioSTAT Solution The objective of the guidelines for electronic datasets is ease of review and analysis. Drawing from years of experience in the design of analysis datasets for the SAS® system, βioSTAT works with the client to produce electronic datasets that meet the specifications of the guidelines. Call for more detail. |
|
To contact us: |
|
BioSTAT Consultants, Inc |
