Technical Rejection Criteria: Are You Ready?
New technical rejection criteria are being added to the existing eCTD validation criteria to ensure study data standards are being utilized when submitting Clinical and Nonclinical data.
What are the new criteria?
What does it mean to the sponsor?
How does it impact your submission?
Shannon Heacock describes the new technical rejection criteria for study data, how they will impact your regulatory submission and ways to minimize the impact of the new criteria and ensure submission compliance.