Japanese Translation of GCDMP Released

Aug. 17, 2010 - PRLog -- MILWAUKEE – Through an international partnership, the Society for Clinical Data Management has published a Japanese translation of its Good Clinical Data Management Practices document.

The translation, of more than 300 pages of English copy, was completed through a partnership with the Center for Pharmaceutical Publishing in Toyko and the Japan Pharmaceutical Manufacturing Association.

“In accordance with SCDM's mission to support data managers worldwide, SCDM is proud to produce the GCDMP in Japanese,” said Ralph J. Russo, CCDM, SCDM Board Chair. “Japan has a bustling pharmaceutical industry with many data managers supporting the pipeline of products with high quality data management practices. Having the GCDMP available in their native language is an ideal way for our Japanese-speaking colleagues to continue fostering best practices in our field.”

Good Clinical Data Management Practices is an award-winning resource of best practices. It is updated frequently to establish industry guidelines as technology and processes evolve. The GCDMP contains 28 chapters on topics including data quality, data base validation, metrics and electronic data capture. It serves as a primary resource for the Certified Clinical Data Manager (CCDM®) exam.

The GCDMP is the first widely accepted set of best practices to be written in Japanese since JPMA published the Green Book in 1994. As homage, the printed copies of the GCDMP are adorned with a green cover.

“The impact of GCDMP translation is immeasurable,” said Osamu Komiyama, vice chair of JPMA’s Biostatistics & Data Management Subcommittee. “Data managers and site personnel have a hunger for a cyclopedic and up-to-date textbook on data management. The Green Book was a bible for Japanese data managers; the GCDMP is their new bible.”

Paper copies of the translation are available for purchase through JPMA; an electronic version can be purchased on the SCDM website at http://www.scdm.org/gcdmp.

The Japan Pharmaceutical Manufacturers Association is an organization of 69 research-oriented pharmaceutical companies. More information can be found at http://www.jpma.or.jp/english.

The Society for Clinical Data Management is a nonprofit professional organization dedicated to promoting excellence in clinical data management through professional development, education and certification. Established in 1994, SCDM has more than 2,600 members with an interest in advancing data management practices. For additional information, please visit http://www.scdm.org.

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The Society for Clinical Data Management is a nonprofit professional organization dedicated to promoting excellence in clinical data management through professional development, education and certification.