Data submission

FDA. Food and Drug Administration. Guidance for Industry, Pharmacoge-nomic Data Submissions. March 2005. 

A online query management system that allows sites to receive queries within minutes of data submission and resolution to be handled and documented immediately (Fig. 23.3)... 

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. 

Ocean Data Evaluation System (ODES) Data Submissions Manual QA/QC Guidance for Sampling and Analysis of Sediments Water and Tissue for Dredged Material Evaluations Chemical Evaluations Quality Assurance Plan for the National Pesticide Survey of Drinking Water Wells Analytical Method 2, Chlorinated Pesticides Quality Assurance Project Plan for Analytical Control and Assessment Activities in the National Study of Chemical Residues in Lake Fish Tissue... 

Guidance for Industry Pharmacogenomic Data Submissions. U.S. Department of Health and Human Services. Food and Drug Administration. Available at http //www.fda.gov/cder/ guidance/5900dft.pdf. 

Frueh FW, Rudman A, Simon K et al. Experience with voluntary and required genomic data submissions to the FDA summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharma-eogenomies workshop. Pharmacogenomics J 2006 6. 296-300. 

However, it is clear that the ease of collecting proteome data currently exceeds the capacity to analyse it. Therefore, international standards are being sought for proteomic experiments, such as the proteomics standards initiative (PSI, http //psidev.source forge.net/), and the proteomics experiment data repository (PEDRo, http //pedro.man.ac.uk). The aim is to provide proteomic researchers with the opportunity to query and reproduce protocols, analyse raw or metadata from other laboratories, and to link the proteome with the respective transcriptome and the metabolome. The Human Proteome Organization (HUPO) is establishing a defined infrastructure for human data submission, and annotation for the numerous proteomic data platforms. This will also be required to effectively develop parasitic flatworm proteomics. 

Salerno RA, Lesko LJ. Pharmacogenomics in drug development and regulatory decision-making the genomic data submission (GDS) proposal. Pharmacogenomics 2004 5(l) 25-30. 

Data submission is an important function of the GenBank site. The most important sources of new data for GenBank are direct submissions from scientists. 

To assist investigators in meeting the requirements of the standard, the MGED Society provides a MIAME-checklist. The checklist outlines the most pertinent points of the standard to facilitate data submission compliance (www.mged.org/Workgroups/MIAME/miame.html). The MIAME standard includes a glossary of the controlled vocabulary used throughout the MIAME document to assist data for submission. 

All three centers are separate points of data submission, but they all exchange this information and make the same database available to the international communities. 

US FDA (2003) Draft Guideline for Industry Pharmacogenomic Data Submissions. November 2003... 

Water Samples. Each water sample received will consist of at least two 1-liter (or quart) amber glass bottles. Store at 4 2°C from collection until extraction. Do not freeze. After a portion of the sample is removed for analysis, the unused portion of the sample is stored at 4 2°C in a locked, limited access area for at least 60 days from the date of data submission. 

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