CDISC Makes Major Strides with Global Regulatory Agencies!
Regulatory agencies worldwide increasingly acknowledge CDISC and its initiatives, paving the way for one Global Standard for Clinical Research!
Study Data Standards for U.S. Regulatory Submissions On 13 September 2013, The U.S. Food and Drug Administration (FDA) released a position statement, recognizing the efforts of a great number of CDISC volunteers over the last decade, and verified publicly that FDA will soon “require study data in conformance to CDISC standards.” The 2013 CDISC International Interchange, to be held from 4-8 November 2013 in Bethesda, MD, will include presentations given from speakers from FDA. For more information on this conference, please visit the CDISC website.
FDA Makes $2 M in Funding Available to CFAST “The money will be used to support an initiative set up last year called the Coalition for Accelerating Standards and Therapies (CFAST), which has the aim of providing a framework to help FDA reviewers assess new therapies more efficiently.” CFAST is an initiative of CDISC and C-Path. Other collaborators are FDA, ACRO, NCI and IMI.
FDA Releases eSource Guidance On 17 September 2013, FDA released Final eSource Guidance. This guidance supports the use of EHRs for
clinical research, as in the CDISC Healthcare Link Initiative. FDA, HHS/ONC and CDISC are still awaiting an innovative Study Sponsor to accept the challenge of 2012. To view details of this challenge, please see our press release.
EMA Draft Policy for Data Access References CDISC
On 24 June 2013, the European Medicines Agency (EMA) released the draft policy on the publication and access to clinical-trial data for a three-month public consultation. Stakeholders had until 30 September 2013 to send their comments on the draft policy to the Agency, so we await the new version. The draft contained the following language: “Wherever technically possible, analysable, de-identified raw CT data should be made available for downloading in the format in which they were analysed by the applicant, submitted and evaluated. For the time being, this can be according to CDISC or other appropriate standard. In future, CDISC shall be the required standard, in line with future guidance from the Agency.” For further information, please visit the EMA press release.
PMDA Begins Pilot Project Requiring CDISC Standards
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) released a statement on 2 September 2013, requesting that companies participate in a pilot, submitting electronic clinical study data to PMDA that has been “amassed and summarized according to the CDISC standards.” This project, which is anticipated to be complete by the end of fiscal year, is to assist the PMDA in boosting the submission of electronic study data. PMDA officials will be presenting at the CDISC International Interchange in Bethesda on 6 November and the Japan Interchange on 5 December with more details on their strategy with respect to CDISC standards. For more details on the 2013 CDISC International Interchange and the 2013 CDISC Japan Interchange, please visit the CDISC website. PMDA also has a liaison to the Japan CDISC Coordinating Committee (J3C).
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