Electronic Clinical Data Submission to the FDA
S-Cubed® CRT is Datafarm’s answer to a complete solution that automatically creates the entire CRT section of an electronic
submission along with the define.pdf and/or define.xml files, SAS transport files and Table of Contents files, including all of the
necessary links and bookmarks. As a Certified CDISC Solutions Provider, Datafarm designed S-Cubed CRT according to the Case
Report Tabulation Data Definition Specification (CRT-DDS) developed by CDISC define.xml team.
S-Cubed CRT helps ensure our clients are compliant with the FDA regulatory requirements that clearly stipulate that all study data must
be delivered in an electronic format - even if the marketing application is in paper format.
The solution lets users automatically
create the CRT in a required format for
the study data that would commonly
including the following:
- SAS Transport files
- Data Definitions file
- Annotated CRT
Regulations in 21 CFR Part 11 require that all datasets submitted in electronic format provide an accurate and complete copy of the data suitable for inspection, review and copying. Currently, the FDA requires that all clinical data be submitted in the SAS System XPORT transport format (Version 5 SAS transport file) for review and archiving. The data definition file describes the format and content of the submitted datasets. In order to increase the level of automation and improve the efficiency of the Regulatory Review process, the FDA announced specifications for dataset data definitions using CDISC SDTM standards. These are then incorporated into the Case Report Tabulation Data Definition Specification (CRT-DDS) developed by the CDISC define.xml team.
S-Cubed CRT Features
- Define files in PDF, XML and RTF formats to meet current and future requirements.
- Create an entire CRT section for a given submission.
- Store, manage and edit metadata in a central repository.
- Supports multi-user access with security, using domain user-id and password.
- Provides 21 CFR Part 11 compliant audit-trail.
- Offers administrative features for application maintenance.
- Supports multiple data sources and SAS dataset versions.
- Enables multi-study operations within a session through the MDI feature.
- Allows user-defined table properties, font attributes and page orientation.
- Verifies CDISC SDM (Submission Data Model).
- Verifies and reports whether your datasets and variables are in compliance with the SDM model.
- Supports the ability to create links to the annotated case report form (blankcrf.pdf) and to external documents.
- Facilitates maintenance for the client such as information management on a shared network area with multiple user access.
- Provides simple metadata import/export.
Compliance Ensured
Included in S-Cubed® CRT is a function that automates the process of annotating case report forms (blankcrf.pdf), which are required by the FDA in all electronic submissions.
- Connects directly to metadata (data dictionary) stored in ODBC compliant database.
- Supports the ability to filter data view by protocol and table names.
- Sorts items by any column.
- Supports the option to define annotation attributes (e.g. table, field, derived field…).
- Enables adding notes for decodes next to annotation.
- Allows annotating multiple pages in one instance.
- Offers the option to save annotation data to a log (CSV) file.
S-Cubed® - When it is this easy and effective, why choose anything else?
S-Cubed® CRT is part of the S-Cubed suite of software that integrates to provide a complete electronic submission solution. The S-Cubed suite includes state of the art modules that deliver comprehensive authoring, publishing, compilation, review, printing and complete lifecycle management of the submission throughout the entire drug development process. Working with Datafarm as your partner and using the S-Cubed® solution will help ensure your regulatory operations delivers compliant applications to the global regulatory agencies today and in the future.
