The US FDA´s Center for Biologics Evaluation and Research (CBER) announced that the Office of Vaccines Research and Review (OVRR) is accepting submission of study data in...[more]
The Submission Data Standards Metadata Team (SDS) of the Clinical Data Interchange Standards Consortium (CDISC) has released a draft version of the Metadata Submission Guidelines,...[more]
A new list (MS Excel) with controlled vocabulary for the RPS R2 DSTU (Draft Standard for Trial Use) has been released on the HL7wiki website by the RPS Controlled Vocabulary...[more]
The US Food and Drug Administration (FDA) has published information concerning an issue with the Electronic Submission Gateway (ESG). According to that, multi-file...[more]
A new version of the ESG (Electronic Submission Gateway) user guide has been released by the FDA. Besides minor corrections, this new version (version date February 9, 2010) takes...[more]
The US Food and Drug Administration (FDA) released a new revision 1.5.1 of the Study Data Specifications applicable for submitting animal and human study datasets in electronic...[more]
RPS release 2 schema files and the DSTU (Draft Standard for Trial USE) agenda and additional material have been posted on the HL7 wiki/Regulated Product Submission...[more]
