Collaboration and inclusivity have always been bedrocks of CDISC
It's been done in a way with too much overhead, [that's] too chaotic, for too long." CDISC
is advocating interoperable standards for clinical trial data to effectively streamline the process of validating some of the substances that go to the FDA for approval.
 Clinical Data Interchange Standards Consortium (CDISC
), Electronic Source Data Interchange (eSDI) Group.
Beyond migrating or mapping proprietary data to CDISC
standards, respondents said that a number of challenges pose significant demands on their already stretched resources, including: Development and support for new standards, processes and infrastructure; developing standards governance structures across functional areas; training people to implement the standards; and putting management processes in place to verify compliance with the new standards.
According to the purpose of how clinical trial data is used, CDISC
provides various standard models.
The Computerized Diagnostic Interview Schedule for Children (CDISC
) (Shaffer, 1992) is a structured, computerized interview used to determine whether youths meet DSM-IV-TR criteria for an alcohol or psychoactive substance use disorder.
He has served three terms as chair, Health Level 7, chair of ISO TC 215 WG2, and chair of the Joint Initiative Council (ISO, CEN, HL7, CDISC
, IHTSDO, and GS1).
The data model for storage would follow CDISC
ODM (or Janus) and SDTM structure to facilitate pooled analysis and regulatory submission.
ViewPoint FUSE 4.2, an electronic data capture platform, produces submission-compliant output, including bookmarked and hyperlinked PDF case report forms, as well as data that is compliant with the Clinical Data Interchange Standards Consortium (CDISC
) Study Data Tabulation Model (SDTM).
It is built on a service-oriented architecture (SOA) that adheres to open standards, such as CDISC
and Web services, and maintains exposed APIs that create a platform on which other clinical development applications can connect.
Models for standard-setting include the Clinical Data Interchange Standards Consortium (CDISC
2004) and the Standards for Exchange of Nonclinical Data (SEND 2004).
However, LOINC is now being used in Digital Imaging and Communication in Medicine (DICOM) ultrasound (9) messages and in Clinical Data Interchange Standards Consortium (CDISC
) pharmaceutical industry (10) messages to identify clinical and laboratory observations, respectively, and could well be used in clinical and research databases for the same purpose.