Appendix_B_-_NIMS_Salient_Characteristics.pdf

Appendix B

Nonclinical Information Management Systems (NIMS) Software Salient Characteristics

If not brand name as specified above, the proposed products shall meet the following salient characteristics:

Nonclinical Data Visualization/Analysis Software Tool – (SDIS & ToxVision++)

1) Software tool shall facilitate access, visualization, and analysis of nonclinical toxicology datasets.

2) Contractor shall propose a tool that provides an integrated environment that includes a hosting repository, visualization and analysis functions, and search and discovery capabilities.

3) Contractor shall install, maintain, and support the software tool.

4) Software tool shall support for the conversion of paper/PDF study data tabulations to a standard electronic format that can be accessed, visualized and analyzed in a consistent manner.

5) Software shall provide integrated data management, access, visualization, and analytical functions to facilitate search and discovery across multiple studies in support of signal identification and validation for toxicity findings.

6) Software tool shall be capable of supporting the export of the converted data in a variety of formats, including .CSV, .XPT, and SEND.XPT.

7) Software tool shall be capable of providing search and discovery in support of signal identification and validation to toxicity findings.

Validation and Search/Discovery Module – (XTEND)

1) Module shall be able to validate against specified rules that ensure conformance to a standardized format. Initially, the validation module shall validate datasets for conformance to the CDSIC SEND standard. Information concerning CDSIC SEND can be found at:

http://www.fda.gov/ForIndustry/DataStandards/default.htm

2) Module shall provide a report stating the outcome of the validation. If validation fails, the report should clearly state the source of the validation failure and prevent loading of datasets with failed validation. If validation passes, the datasets shall be automatically loaded onto the repository and be available for viewing and manipulation in the visualization and analysis tool (described below).

3) Module shall be flexible to accommodate changes in the validation rules.

4) Module shall be based on publicly available validation rules.

5) Module shall work seamlessly with the repository and visualization and analysis tool.

6) Module shall allow scientists to explore toxicological trends, signals, and investigate study correlations within and across product submissions in the repository.

7) Software module shall enable scientists to search results and interact with results through tabular views, graphical visualizations and thematic data browsers.

8) Provide the capability to search for correlations, patterns, trends, and outliers in multiple dimensions, including study types, findings, compounds, and animals.

Appendix B

Nonclinical Data Repository – (NSDR)

1) Contractor shall provide a repository for staging and hosting the nonclinical data. This data repository shall be seamlessly integrated with the visualization and analysis software.

2) Repository shall have search and discovery capabilities.

3) Repository shall be based on a data model that is capable of uploading validated data from various formats including CDISC SEND, HL7 standards, and non-standardized datasets.

4) Repository shall support and work seamlessly with a validation module for standard data.

Initially, the validation module shall validate datasets for conformance to the CDSIC SEND standard.

5) Repository shall support automated data extraction (including metadata), normalization, transformation, and loading of non-standardized electronic datasets. These datasets shall then be available for viewing and manipulation in the visualization and analysis tool (described below).

6) Repository shall support extraction, normalization, transformation, and loading of datasets generated from a data conversion service (i.e., from paper/pdf). These datasets shall then be available for viewing and manipulation in the visualization and analysis tools.

7) Repository shall be able to publish/export data in various formats including .XPT, .CSV, .XML, and SEND.XPT