Drug Evaluation Committee CDISC and Electronic Data Submission Documents Resource Collection (4th Edition) (February 2021)
February 2021
A vast amount of information regarding CDISC standards and electronic data submission is continuously being released not only by CDISC and regulatory authorities (FDA and PMDA) but also by various other organizations. While it is crucial for pharmaceutical companies to identify key information from this vast amount of data and stay up to date, this process is cumbersome and extremely time-consuming.
In light of updates to various information websites, we have updated the “CDISC and Electronic Data Submission Resource Collection, 3rd Edition,” which was originally published in February 2017.
We hope this resource collection will serve as a “compass”—a tool to help companies prioritize, understand, and utilize the ever-increasing volume of information regarding CDISC standards and electronic data submission.
Data Science Subcommittee
FY2020 Task Force 7
Note: To make the most effective use of this resource collection, please also refer to the following presentation materials:
Presentation materials from the workshop for practitioners on electronic data submission at the time of application, held on February 15, 2021
Introduction to the Resource Collection on Electronic Data for Regulatory Submissions (2.8MB)