Following on from our previous blog posts on Integrated Summary tips, another aspect that can be considered is the cost and quality of producing integrated summaries and how CDISC and CDASH can aid in reducing costs and improving quality for ISS ISE submissions.
Some factors that may reduce cost include, but are not limited to, the following –
There are several recommendations that can be made when performing quality control of integrated summary studies.
Preparation of Datasets/Domains
Integrated Summary Analysis Plans
Taking these factors into consideration should aid in producing quality integrated summaries for regulatory submissions at a low cost. CDISC SDTM domains as mentioned are important in this process as the FDA recommends submissions to be made in this format.
Related Blog Posts
Address - UK HQ:
Address - US HQ: