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  • Regulatory NewsRegulatory News

    CDER Plots Pilot Project to Test CDISC Standard

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated standard, known as the SEND 3.1, from the Clinical Data Interchange Standards Consortium (CDISC). CDER is seeking a maximum of five participants for the pilot, which will evaluate the compliance of sample SEND 3.1 datasets subm...
  • Regulatory NewsRegulatory News

    CDISC Unveils New Standard for Clinical Trial Registries

    • 09 May 2016
    The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov from a single file. The standard, known as the Clinical Trial Registry (CTR) XML, is inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 2...
  • FDA Looks to Evaluate Probable Replacement for Current Drug, Biologic Data Submission Standard

    US regulators have announced the launch of a new pilot project that will see the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) move toward a new data submission format. Background As FDA explained in a 26 November 2013 Federal Register posting , FDA currently supports an ASCII-based data submission format known as SAS Transport, or XPORT (v.5). The standard was first deve...
  • FDA Dropping Support for Study Data Submission Format

    The US Food and Drug Administration (FDA) will cease to support an older version of an electronic study data submission format in favor of a newer version of the same standard, it has announced . The change affects all submissions made to the Centers for Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER) or Devices and Radiological Health (CDRH) using the Clinical Data Interchange Standard Consortium (CDISC) Study Tabulation Model (SDTM) Imple...
  • Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

    The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...
  • Consortium Brings Together FDA, Industry to Release New Data Reporting Standard

    Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies. The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial...
  • FDA, Data Standard Groups Promote Adoption of EHRs

    The US Food and Drug Administration (FDA), the US Department of Health and Human Services' (DHHS) Office of the National Coordinator for Health Technology (ONC) and the Clinical Data Interchange Standards Consortium (CDISC) have together issued a call for greater use of electronic health records (EHR) in clinical research. In a 6 August statement, CDISC, a nonprofit devoted to clinical regulatory standards, said the agencies' challenge involved the, "Use at least two d...
  • New Regulatory Data Standards Partnership Formed to Accelerate Research

    A new partnership between two regulatory organizations supported by the US Food and Drug Administration (FDA) has the potential to accelerate clinical research and medical product development, the groups said in a statement. In a 21 June statement, the Clinical Data Interchange Standards Consortium (CDISC) and the Critical path Institute (C-Path), announced the formation of a partnership with FDA to develop new data standards, tools and methods to guide the development o...
  • CBER Announces Electronic Submission Pilot Program

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) announced 28 February that it intends to conduct a pilot evaluation program for a new electronic data standard format to support application reviews. The new standard, developed by the Clinical Data Interchange Standards Consortium (CDISC), is known as the Standard for Exchange of Nonclinical Data (SEND). "FDA believes the use of standardized SEND datasets, together with ne...