Electronic data submission

Some data submitters were concerned about whether the supplemental files would be archived along with the data, and whether the supplemental files would be subject to Freedom of Information Act (FOIA) requests. OPP expects to maintain the CD provided as the electronic data submission, and archive the supplemental files on CD along with the rest of the electronic data submission. However, the official archive format at the present time is paper, and the supplemental files duplicate material in the paper submission. Supplemental files may be released upon FOIA requests after the first registration for the pesticide active ingredient, subject to the requirements of FIFRA 10(g), which include an affirmation statement from the requestor and a notice to the data owner, and exclude any FIFRA CBI. 

OPP scientists evaluated PDF submissions and supplemental files. For a pilot electronic data submission, OPP discussed the content of supplemental files with the registrant interested in providing an electronic data submission and worked on the data fields of interest for several toxicology studies. OPP evaluated SAS-XPORT (SAS Transport) files as a neutral file format for data tables. Two programs were evaluated by OPP DBMA Copy and Stat Transfer, which will transfer the data from the SAS-XPORT format into a format usable by the reviewer. 

XML will become more integral to the work of statistical programmers in the pharmaceutical industry as the standards, applications providers, and vendors make more use of this technology. Eventually you should expect the FDA to move away from SAS transport files to XML files as their standard data format for electronic data submission. 

ANDAs. Information on electronic data sets that accompany an ANDA submission ... 

It is recognized that harmonized formats for data submissions are beneficial. Detailed guidance in this area wiU lead to a lower submission rejection rate by regulatory jurisdictions, will facilitate electronic submission, and will result in efficiency gains. There are several initiatives underway in this area. 

Values in at least two [laboratory records] were altered. Altered values were written under computer generated values. .. and used in potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to the Drug Master File. [FDA Warning Fetter, 2000]... 

Report of the OECD Workshop on Electronic Tools for Data Submission (2003). 

For the data collection, the HEDSET software package (Harmonized Electronic Data SET), a special computer programme, was developed. Industry must use this software for the compilation and submission of the data. The software has been designed to run on standard personal computers and is available in 9 EU-languages. 

Laboratory notebooks—It may be debatable to consider laboratory notebooks as text documents, but they should be mentioned here because of their importance in preclinical development. Laboratory notebooks are used to record experimental procedures, observations, raw data, and other important information. Although laboratory notebooks are rarely used for submission to regulatory agencies directly, they are available for inspection by the authorities in the Preapproval Inspection (PAI) and other GMP/GLP-related inspections. Currently, most of the major pharmaceutical companies still use paper-based laboratory notebooks. Electronic-based notebook systems are being developed and commercialized, which are discussed in Chapter 9. 

There are hidden gold mines under our noses—in house data becomes the new lamps for old on the tons of old clinical data from 50 years of R D— but of course, none of it is electronically accessible. It is called a library Many organizations have undertaken huge OCR (optical character recognition) projects to scan laboratory notebooks—some data even exists on microfilm and microfiche. As it is a legal requirement for a drug submission to provide provenance of scanned notebooks [38], paper, and microfilm, many businesses concentrate solely on the capture and verification of this data, rather than considering it a valuable resource to be remined. 

The success of electronic submissions depends on the ability of industry to publish documents electronically and on paper. These versions must be identical the electronic version must offer the ease of use of the Web. The current way of thinking is in the direction of how do we get our data on to paper . Perhaps a better way to think... 

OPP scientists are identifying the data elements (or fields) of interest for each study type where the reviewers felt that supplemental files would be useful, are identifying other information for each study type, which would be useful to have as electronic files, and are developing guidance for submission of supplemental files. This guidance is not ready to be published, but the scientists will work with the data submitters to ensure that the supplemental files for the particular study will be useful to the science reviewers. Even when guidance becomes available, OPP intends to be fiexible about the format of the supplemental files and will modify the guidance as needed. 

Case Report Tabulation Data Definition Specification (Define.xml). Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it. 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

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