14 Jul CDISC SDTM Implementation Guide (SDS Version ) This Implementation Guide comprises version of the Submission Data Standards. 12 Nov CDISC SDTM Implementation Guide (Version ) This is the implementation guide for Human Clinical Trials corresponding to Version 11 Jan ➢SDTM IG / SDTM ➢SDTM IG DRAFT. ➢SDTMIG-MD touched on throughout. ➢ Device Identifiers (DI). ➢ Device In-Use (DU).
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The data sets and columns required for a regulatory application are not prescribed by the standard.
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If dstm still can’t find the manual for your product, use our free customer service on Facebook. Instead, these requirements are based on the trial protocol and discussions with the regulatory authority in charge of reviewing the submission.
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