| L'iniziativa CDISC |
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CDISC è l’acronimo di CLINICAL DATA INTERCHANGE STANDARD CONSORTIUM, da cui si deduce chiaramente l’obiettivo di questa organizzazione. Fra i principali standard implementati si identificano per esempio (dal sito http://www.cdisc.org/ ): Study Data Tabulation Model (SDTM) - The current version is 3.1.1. There is a lengthy Implementation Guide with instructions and examples of how to implement. Operational Data Model (ODM) – The current version is 1.2.1. Version 1.3 Draft is currently posted for comment. This version will enhance v 1.2 such that it can support SDTM metadata for regulatory submission. Case Report Tabulation Data Definition Specification (CRT-DDS) Define.xml – The current version is 1.0. This is a means to submit SDTM metadata to FDA in an ODM XML format. In particolare, per quanto riguarda la relazione dell'iniziativa CDISC e degli standard sviluppati e eCTD si evidenzia che "SDTM and define.xml are referenced as specifications for FDA Guidance". Ma molte altre presentazioni e documenti presenti nel sito FDA fanno riferimento a questi standard, fra questi indichiamo per esempio il documento Guidance for Industry - Pharmacogenomic Data Submissions - Companion Guidance – Draft del 24-8-2007 dove si evidenzia: "The preferred submission standard for clinical data is the Clinical Data Interchanges Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) standard." Interessante anche il “Docket No. FDA-2008-N-04281 - Electronic Study Data Submission for Phase 3 Janus Operational Pilot; Notice of Pilot Project - AGENCY: Food and Drug Administration, HHS” del 18-8-2008. Nel paragrafo background di questo documento si riporta: In guidance for industry titled "Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Application and Related Submissions Using the eCTD Specifications," FDA makes recommendations about how to submit documents in electronic format for investigational new drug (IND) applications, biologic license applications (BLAs), and new drug applications (NDAs) using the electronic common technical document (eCTD) specifications. In Section III.E.4 of that guidance, FDA refers to the CDISC SDTM as the Study Data Specification for voluntary electronic submission of clinical study data.Sul sito http://www.cdisc.org/ è inoltre presente una sezione specifica per “FDA Information/Documents relevant to CDISC” . Sottolineiamo inoltre che anche in EMEA si stanno valutando questi standard.
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