Drug Evaluation Committee CDISC and Electronic Data Submission Documents Resource Book (4th Edition) (February 2021) (February 2021)
Data Science Subcommittee
February 2021
A great deal of information on CDISC standards and electronic data submission is continuously being disseminated not only by CDISC and regulatory authorities (FDA and PMDA) but also by various other organizations. It is important for pharmaceutical companies to identify important information from this vast amount of information and to keep up-to-date with the latest information, but this is a complicated and very time-consuming task.
In line with the updates to the various information websites, we have updated the CDISC and Electronic Data Submission Related Documents Resource Collection, Third Edition, which was released in February 2017.
We hope that this resource collection will serve as a compass to help you decide how to prioritize and understand/utilize the ever-increasing information on CDISC standards and electronic data submission.
Data Science Subcommittee
FY2020 Task Force 7
Supplement: To make better use of this resource collection, please also refer to the following presentation materials.
Presentation materials from the February 15, 2021 Workshop for Practitioners on Electronic Data Submission at the Time of Application
Deliverables of the Drug Evaluation Committee Return to list of all deliverables