The benefits of standardized data are well known — it improves communication; it makes better use of time and resources; it facilitates comparison; it adds transparency; it enhances data sharing and collaborators among scientists, studies and companies; and it eases the development of new software and tools.

Most importantly, said Clinipace’s Nicola Tambascia, more and more global regulatory agencies require standardized data as part of the submission process.

“Officials at the Food and Drug Administration receive hundreds of applications each year that reference thousands and thousands of pieces of data, so you can imagine how confusing that could be without standardization,” Tambascia said.

Tambascia, Principal Statistical Programmer at Clinipace, led a complimentary webcast April 5 called “An Overview in Clinical Data Standardization in Electronic Submissions (CDISC).” The purpose of the webcast was to provide an understanding of standardized data to help people stay abreast of evolving regulatory requirements.

During the webcast, Tambascia covered:

  • The benefits of clinical data standardization,
  • How international requirements for data standardization differ between regulatory agencies,
  • The goals and background of different CDISC standards, and
  • Deliverables.

Regulatory agencies that require standardized data include the FDA in the United States and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

As part of the webcast, Tambascia discussed CDISC, an acronym for Clinical Data Interchange Standards Consortium.

CDSIC is a global, open, multidisciplinary, nonprofit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. CDISC provides most of the data standards, like SDTM and ADaM, requested by regulatory authorities — making in-depth knowledge of these standards key for a successful submission.

An audio recording and slide deck of Tambascia’s presentation are available at no cost. Request the materials.

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