CDISC data standards are now applied to various phases of clinical research and are rapidly becoming industry standard.Starting at the end of 2016, the SDTM, ADa M and Define-XML will be the only supported formats for all clinical data submitted to the FDA.The position mandates a strong programming expertise in clinical trials with experience in CDISC SDTM and ADa M dataset/spec generation.and document statistical analysis programs for clinical trials based on the statistical analysis plan (SAP) and other specified trial documents following QPS standards and SOPs.QPS welcomes employees who want to be part of a growing organization.As a principal scientist global data and bioinformatics, position is responsible for coordinating with the data management and statistical heads within the QPS data and statistical centers in creating and maintaining Enterprise level (global) standards for clinical data, data transfers from external vendors, CDISC-compliant database nomenclature, SDTM output in data sets Associated with this responsibility will be oversight with the QPS clinical sites in the creation of global standard operating procedures for and quality management of processes of data management and statistical programming.FDA reviewers are requesting sponsors to use the SDTM model to vastly improve their review efficiency and accuracy.The analysis datasets can be prepared in the ADa M format to ensure traceability between the analysis domains and the SDTM domains.
For more information see the following PMDA page: When new study types or versions of the SEND Implementation Guide are brought online, when will they be required? When will Respiratory and Cardiovascular be required? It is expected that larger scale additions (such as completely new subject areas) will have a longer timeframe for Sponsors to implement and ramp up before it becomes required.
Note: The content of this page was prepared by Ph USE working group and SEND team members and should not be considered as official FDA responses.
This content exists to concisely summarize answers that are usually available buried within other documents or pages, to provide implementers with quick, unofficial, and useful answers to their questions. SEND, or the Standard for Exchange of Nonclinical Data, is an implementation of the CDISC Standard Data Tabulation Model (SDTM) which specifies a way to present nonclinical data in a consistent format. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is working to adopt CDISC standards including SEND. (Note: this pertains to updates made the initial SEND requirement laid out in the previous question, e.g., IG updates, new study types, etc.) After new standards or updates are published, pending an evaluation by CDER, CDER will add the standard to the Study Data Standards Resources page with a timeframe for requirement.
They can even produce ad-hoc reports and perform It will be very useful for the sponsor to run the Web SDM checks on the clinical data because the FDA reviewers also use the same application to review the data.
We are an active member of the Clinical Data Interchange Standards Consortium (CDISC) and a Registered Solutions Provider.