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Phase US Connect 2019 Paper SA06Developing SEND for CBR Collaborative Work stream Initiative Lisa Lin, FDA, White Oak, MD, USA Susan Heaven, Sanofi US Inc., Bridgewater, NJ, USA ABSTRACT The Center
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Researchers and statisticians involved in clinical studies or trials that utilize SAS software and adhere to CDISC standards may need SAS CDISC proceedings.
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Regulatory authorities, such as the FDA, may require the submission of SAS CDISC proceedings for the review of clinical trial data.
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Pharmaceutical companies or organizations engaged in drug development may also need SAS CDISC proceedings for documentation and compliance purposes.
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SAS CDISC proceedings refer to the submission of clinical trial data in CDISC (Clinical Data Interchange Standards Consortium) format using SAS software.
Biopharmaceutical companies conducting clinical trials are required to file SAS CDISC proceedings.
SAS CDISC proceedings can be filled out using SAS software and following the CDISC standards for data submission.
The purpose of SAS CDISC proceedings is to standardize the submission of clinical trial data to regulatory authorities for review.
SAS CDISC proceedings must include standardized clinical trial data such as demographics, adverse events, efficacy endpoints, etc.
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